Withania somnifera / Ashwaganda
Ashwagandha: Wonder Herb of India.
There is an herb regarded as a 1st class adaptogenic tonic in one of the world's greatest herbal medical systems, an herb which can compare favorably to the world’s most renowned herbal tonics such as ginseng (Panax ginseng) , astragalus (Astragalus membranaceus) , dang gui (Angelica sinensis), reishi mushroom (Ganoderma lucidum) and South American suma (Pfaffia paniculata) and like these has been held in high regard by generations of people over the course of millennia for its ability to increase vitality, energy, endurance and stamina , promote longevity and strengthen the immune system without stimulating the body’s reserves. In fact having the ability to nurture the nervous system, counteract anxiety and stress to promote a calm state of mind. this same herb, having powerful anti-inflammatory properties, is specific for treating arthritic and rheumatic conditions. As if all of this were not enough, it is easily the most potent tonic aphrodisiacs in the entire botanical kingdom. With all of these uses, Withania somnifera, better known in India as ashwagandha, is destined to rise significantly and take its place with all the other better known tonics.
In 1978, as part of a tour to India, I had the opportunity to live in a small South Indian village outside of Bangalor, for three weeks. One day my gracious host and I were walking at sunset along the dirt road adjacent to a cultivated field of rice, and knowing my interest in native Indian herbs and the ancient traditional system of medicine called Ayurveda, he casually pointed out a few non-descript plants growing on the border of a rice field as Ashwagandha. I was very excited to see this remarkable plant which I had only recently studied in various books in the United States. I made way walking along the drier border of the rice field and picked several of the seed laden red berries to bring back to my residence and herb school in Santa Cruz, called the Garden of Sanjivani.
It was early in my career and I was so linked with my identity as an herbalist that I often mused whether I could serve as an herb doctor in a country where the native plants were unfamiliar. So far, in the village where I stayed, ashwagandha and the neem tree were the only native herbs I knew. Notwithstanding this fact, many local villagers, wanting to meet their esteemed visitor from America, hearing that I was involved in healing, came to the abode where I was staying seeking advice for a wide variety of problems. Fortunately, most of these were of a chronic type associated with aging and it just so happened that the single native herb to which I was recently introduced, ashwagandha, was perfect.
One of the important lessons I was to learn from this experience was that being an herb doctor meant more than a knowledge of a particular set of familiar herbs. It also included the ability to ‘think like an herbalist’ to be ever vigilant and watchful for the gifts that nature abundantly provides everywhere in the form of both botanicals as well as the local knowledge and wisdom of the use of plants.
One man in his early 80’s came complaining of chronic pain in his lower back and elbow. I directed him to my new found patch of ashwagandha and he sent one of his sons out to dig some roots for him to make tea. Three days later, he came to thank me since he had already showed considerable improvement. Another young child was suffering from a severe adverse reaction to a recent polio vaccine. The arm that had been injected with the vaccine only a few months previous hung limp and malformed from lack of proper maturation. The villagers commented that every time the local medical core visited their village to administer vaccinations, there were always a few such casualties. I remember thinking how in a more alienated society such as the Western world, such things may also happen, but our neighbors have no opportunity to witness such reactions because our lives are so separate compared to that of a South Indian village. Once again, ashwagandha was the perfect herb to give for non-inflammatory childhood mal-development.
A young boy around the age of 14 was brought to me with chronic bronchitis. After taking ashwagandha for only a week, he was completely cured. I must confess that I was a little trepidatious of becoming known as the “one herb doctor from America”. Since no one else seemed to care and everyone was getting such positive results from ashwagandha. I took consolation in the famous axiom of the late Dr. Christopher, “it is better to know one herb well, than a smattering of many”.
During my stay, I had the opportunity to prescribed ashwagandha for a wide variety of conditions ranging from male impotence, for which Withania is a near specific, to chronic vaginal discharge. For many of these I was not there long enough to directly observe the results, but I was later told that everyone to whom I had recommended the herb had either experienced significant improvement or in more had completely recovered from their chronic condition.
Interestingly, the people took no notice of the fact that I was recommending the same herb to everyone. In fact, it was a local herb with which they were all very familiar. Its a curious thing that I had observed when living in proximity with the Karok Indians of Northern California that some native people, having recently fallen under the seduction of Western ways including Western medicine, actually appreciated being reminded, especially from a representative of much envied and powerful country such as the US, of the powerful yet much safer effects of their native medicine. Placebo effect notwithstanding, it seemed that the fact that I recommend it seemed to make it all the more powerful and effective in their eyes.
Three months later I returned to the Garden of Sanjivani in Santa Cruz and planted my ashwagandha seeds. I was amazed at how easily they germinated and continue to re-seed themselves year after year in the area bordering the San Lorenzo river, long after I had moved away. Despite this, one need not be concerned about its becoming an invasive pest. Since it is as easy to control as another more famous Solanaceae representative, the tomato to which it is closely related.
Over the years I have noticed how herbs with more complex, seemingly opposite properties, such as ashwagandha, are generally the strongest and most useful. Unlike many tonics, Ashwagandha is also anti-inflammatory, anti-arthritic, anti-anxiety calmative and aphrodisiac. To herbalists, this seems strange since it is also a member of a family of plants that include the familiar belladonna and henbane, also well respected anti-inflammatory nervines but toxic not particularly known for their nutritional tonic properties. This certainly qualifies ashwagandha as one of the most paradoxical herbs. Perhaps it is for this reason that so far it has not yet established itself with the equal esteem of the other more well known tonics mentioned above.
There is still one other highly significant and practical fact about ashwagandha. Most tonics like ginseng, require special growing conditions and several years to develop their tonic properties (ginseng requires 7 years). Ashwagandha is unique as a tonic herb in that it is exceptionally easy to cultivate and is ready for harvest after only one year of growth. This represents a very real consideration that if ashwagandha were used more, would relieve some of the threat of extinction from the wild of other highly popular herbs such as wild ginseng (Panax quinquefolium), golden seal (Hydrastis canadensis) , suma (Pfaffia paniculata) and lady’s slipper (cypripedium pubescens) for instance. This is not to say that any tonic can be substituted for each other, but too often, because of excessive commercial promotion, people are induced to overuse and just as often, misuse certain endangered herbs for purposes that another more common herb may be even more effective.
The unique properties of ashwagandha  , while being an energy tonic like ginseng or codonopsis for instance, is uniquely more beneficial for calming the mind, relieving arthritis and building sexual energy while ginseng and codonopsis (Codonopsis pilosula also known as “bastard ginseng” because it is an acceptable milder substitute) is more specifically effective for low energy caused by digestive weakness. Astragalus, classified as another Qi or energy tonic in Traditional Chinese Medicine (TCM), is stronger as an immune tonic. Again, these properties are equally shared by ginseng, codonopsis and ashwagandha, but more indirectly because of their effects on other physiological systems. Ashwagandha is also useful for strengthening the female reproductive system for which it is commonly combined with another Ayurvedic herb called shatavari (Asparagus racemosa) but the Chinese herb, dang gui (Angelica sinensis and A. acutiloba), renowned as a blood tonic, is especially beneficial in gynecology for deficient blood conditions, anemia and irregular menstruation. The uniqueness of Ashwagandha is that it achieves its results through strengthening the nervous system and potentiate reproductive hormones.
Also known in English as winter cherry, Ashwagandha is one of the most highly valuable herb in the Ayurvedic medical system. On another trip to India I met with several Ayurvedic doctors and heads of prominent Ayurvedic pharmacies. I decided to ask them the kind of inane  question that I am often asked, “what do you think is the most valuable Ayurvedic herb?” There was an unequivocal answer that ashwagandha was at least equally regarded in Ayurvedic medicine as ginseng is in TCM.
In order to appreciate the traditional uses and properties of ashwagandha it is necessary to offer a brief description of the Ayurvedic system of medicine. Ayurveda, translated as Science of Health, is probably the oldest existing system of natural healing in the world. Dating back over many millennia, it is likely to be even older than Traditional Chinese Medicine (TCM) and may be its origin, as it certainly is the origin of Tibetan medicine, Middle Eastern Tibb medicine and our own ancient Greco-Roman medicine. Nearly suppressed by the English during their occupation of India through the 19th and first part of the 20th centuries, Ayurveda is finally making significant inroads of acceptability throughout all countries of the Western world.
Ayurveda is based on a system of Tridosha or Three Humours which classifies all Dating back over many millennia, it may go back even further in antiquity than TCM and is certainly the basis for Traditional Tibetan Medicine  , Middle Eastern Tibb or Unani medicine which form the basis for much of ancient Greco-Roman medicine  . Nearly suppressed in India by the occupying English during the 19th and early 20th centuries, Ayurveda is gaining in popularity throughout many Western countries.
Ayurveda is based on a system of Tridosha or Three Humours which classifies all individual constitutions of people, diseases, herbs and other non-herbal remedies and therapies according to whether they are Vata (air or nerve oriented), Kapha (water or mucoid type) or Pitta (fire type)  . Herbs that have pungent, sour and salty flavors stimulate fire; herbs that are astringent (drying) and bitter stimulate vata-air, or the nerve centered humour; herbs that are sweet, salty and sour stimulate or increase Kapha-water, or the mucoid humour. In contrast, herbs that are sweet, sour and salty flavored ameliorate Vata-air, which means that they have a particular affinity for the nervous system. Herbs that are astringent, sweet and bitter ameliorate Pitta-fire, meaning that they are soothing and anti-inflammatory. Finally herbs that are pungent, bitter and astringent ameliorate Kapha-water, which means they tend to increase digestive fire, expel and dry excessive fluid build up in the system, including clearing excessive fat from the body, and the accumulation of cholesterol and other fatty deposits in the veins and arteries of the body.
Because the primary quality and flavor of ashwagandha is sharp and pungent, this indicates that it is warming, raises metabolism, stimulates digestion, clears mucus, improves circulation. Unlike TCM, Ayurvedic also identifies a secondary post-digestive flavor, which for ashwagandha is sweet. It is this effect, which is not necessarily directly identified by one’s sense of taste, that occurs when a substance is converted into a still purer nutritive extract  . Following this, the post digestive sweet flavor of ashwagandha represents its deep nutritive, hormonal properties as well as its ability to strengthen and nourish the nervous system.
An even deeper and more profound transformation of food occurs after 7 days. This is when food is transformed into blood. Only after a month does the most refined essence of food transform into semen. It is at this deepest level that ashwagandha exhibits its profound aphrodisiac properties.
In the TCM system, ashwagandha would be used as a Kidney Yang tonic because of its warming, aphrodisiac properties. In this, it is deeper acting than other herbs, such as the African yohimbe, the South America muira puama or the milder Central American damiana. One may have to take ashwagandha longer, at least a month, to notice its aphrodisiac effects.
The distinctive earthy odor and flavor of ashwagandha is due to the presence of certain steroidal lactones or Withanolides  . It is from this characteristic odor which its Sanskrit name, "like a horse", derives. While the largest majority of medicinal herbs are not particularly prized or known for their appealing flavor, ashwagandha for most may be promoted to the forefront of those herbs with the least taste-smell appeal. Fortunately, it is possible to formulate ashwagandha into pills, capsules and alcoholic extracts to create greater public acceptance.
Traditionally, herbs are classified organoleptically according to their smell, flavor, texture, shape and even their color  . This has been the traditional way for herbalists in older times to come to a recognition of the unique biochemistry and therapeutic actions of plants. It is only in recent times that this is being replaced by complex laboratory analysis. The post digestive flavor of Ashwagandha is not so much sensorially identified, but because it exhibits tonic nutritive properties. The classification of herbs, foods and substances into the category of flavors, may not always be based on individual sensory experiences but also according to function.
Different people will have different reactions but for most, at first the reaction to taking ashwagandha even after a few days is a sense of increased warmth and more energy. As stated, eventually this further transmutes to heightened libido. For this reason, tonics like ashwagandha or ginseng are seldom prescribed to otherwise normal and relatively healthy adolescents or for that matter, otherwise normal individuals under the age of 40 years. Given specific signs and indications of chronic weakness and deficiency, ashwagandha is, however, specifically indicated for individuals of all ages. For such conditions, it is best to take ashwagandha in powder or alcoholic extract with warm scalded milk and honey.
So why is it that more people do not know or use ashwagandha? Mainly because it has not yet permeated the arena of the largely fad-driven natural supplements industry of the West. An important second reason is that many, including most Western herbalists, as yet do not fully understand and appreciate the many diametrically opposed and therefore, confusing therapeutic properties of this valuable herb. Supplements become best sellers when the industry can latch onto one specific attribute of a particular substance to popularize. This, unfortunately, has happened to many herbs such as Feverfew and St. Johnswort (Hypericum perfoliatum), both herbs having more extensive therapeutic properties than that for which they have become popularly known.
The issue of herbal marketing poses some further serious reservations among herbalists, not only because it can create a demand for a particular herb that can threaten its survival, as in the case of wild golden seal (Hydrastis canadensis), American ginseng (Panax quinquefolium), osha (ligusticum porteri) and ladies slipper (Cypripedium pubescens), but also because of the y to create concentrated extracts to heighten certain drug-like effects. This has certainly been true of Chinese ephedra also known as Ma Huang which has epinephrine and pseudo-epinephrine alkaloids that are very similar to adrenaline. Ma Huang is traditionally one of the best herbs for treating asthma. However, by overly concentrating its herbal constituents, it is more drug-like with properties similar to meth-amphetamine, and it is in that form that it is abused in the popular herb market place included as a stimulant in herbal pep pills, diet formulas and even in pseudo-mind altering formulas. When prepared in this way, Ma Huang can be more of a health risk than a benefit. As a result of incidents implicating it as the cause of certain adverse reactions, the popular availability of the herb may be threatened as a result of stepped up legal restrictions.
Given the sensational tendency of marketeering, the aphrodisiac effects of ashwagandha may take precedence over all its other outstanding properties. Ashwagandha should be considered as the premiere herb for all negative conditions associated with aging  . This includes its use for the prevention and inhibition of senile dementia and Alzheimer’s Disease  , low energy and arthritis  .
The other important properties of ashwagandha includes its traditional use as an alterative for detoxification, anti-inflammatory, antiseptic, antitussive (alleviating coughs), bitter (in small doses, stimulating appetite), sedative and as an overall rejuvenative.
Ashwagandha is specific for a wide range of conditions including arthritic inflammation, anxiety, insomnia, respiratory disorders including emphysema, asthma bronchitis and coughs, nervous disorders, gynecological disorders, especially functional female and male infertility and impotence. From this it would seem that ashwagandha should be considered for all immuno-compromised diseases including TB and AIDS, chronic upper respiratory diseases, degenerative symptoms attendant to aging, juvenile mal-development and growth, chronic neurological diseases especially anxiety, nervousness, depression and insomnia, weak digestion, fluid retention caused by lowered body metabolism and last but certainly not least, for low sexual libido.
Other Species and Parts of the Herb that are Used
So far, all discussion is about the use of the root which possesses the most valued tonic properties. However, the bitter leaves are used as a hypnotic in the treatment of alcoholism and to relax the spasms of the lungs for the treatment of asthma and emphysema. They can also be made into an anti-inflammatory poultice and topically applied for boils and carbuncles. Internally, as with so many other strongly bitter herbs, they are anthelmintic (clearing worms). The seeds of the fruits are diuretic and can be used as a substitute for rennet to curdle milk.
Ashwagandha Coagulans, a related species and occasional adulterant, primarily uses the inside kernel of the seed capsule containing “withanin” which is similar to rennet to curdle milk. “About a tablespoon of the mixture of seeds with a little milk (1 in 40) is enough to coagulate a gallon of milk in approximately a half an hour.”  Alcohol will destroy the coagulating principle but the dried capsules can be used. A. coagulans is also therapeutically used as an alterative and emetic.
History, Description and Pharmacology
The use of ashwagandha in Ayurvedic medicine extends back over 3000 to 4000 years to the teachings of an esteemed rishi (sage) Punarvasu Atriya  . It has been described in the sacred texts of Ayurveda, including the Charaka and Sushruta Samhitas where it is widely extolled as a tonic especially for emaciation in people of all ages including babies, enhancing the reproductive function of both men and women. It has also been used for inflammations especially for arthritic and rheumatic conditions and as a major tonic to counteract the ravages of aging and promote youthful longevity. Some of its other traditional uses have been as a mild purgative for chronic constipation and for the treatment of swollen glands.
Ashwagandha is a small woody shrub or herb in the Solanaceae family that grows usually about 2 feet in height and is naturally found in diverse areas ranging from Africa, the Mediterranean and East into India. Because of its wide range, there is considerable morphological and chemotypical variations in terms of local species. Considering its powerful healing properties, except for the bright red fruit, it is a fairly plain, nondescript plant. The fruit is harvested in the late fall and the bright yellow seeds are dried for planting in the following spring. The cultivated Nagori species of Ashwagandha seems to be significantly larger, one source describing it as a shrub growing from 5 to 7 feet tall. However, the primary alkaloids of both the wild as well as the cultivated species are the same.
The commercial supplies of ashwagandha are obtained from both wild and commercial sources. The fresh root of one year old plants are harvested from January to March. It is either dried whole or cut in short transverse pieces and dried directly in the sun. Quality is determined by the size of the main tap root as well as its color, odor and flavor.
The major biochemical constituents of ashwagandha from which its primary medicinal properties emanate, are based upon the actions of certain steroidal alkaloids and steroidal lactones in a class of constituents called withanolides  . These serve as important hormone precursors which the body is then able, as needed, to convert into human physiological hormones. If there is an excess of a certain hormone, the plant based hormone precursors occupy the so-called hormone receptor sites, without converting to human hormones, to block absorption. In this way, ashwagandha, like other adaptogenic tonic herbs, is amphoteric and can serve to regulate important physiological processes, increasing or decreasing as needed.
The term adaptogen was first defined by the Russians  as a result of their extensive research on the tonic, Siberian Ginseng (Eleutherococcus senticosus). The definition of adaptogen is based on the following, according to Brekhman: 1). Safety of the adaptogen’s action on the organism; 2). A wide range of regulatory activity, but manifesting its action only against the actual challenge to the system; 3). Act through a nonspecific mechanism to increase the nonspecific resistance (NSR) to harmful influences of an extremely wide spectrum of physical, chemical and biological factors causing stress; 4). Has a normalizing action irrespective of the direction of foregoing pathological changes.
An adaptogenic herb of which ashwagandha would be a first rate example  , allows one to adapt to a variety of is a class of herbs that allows one to adapt to a variety of heightened stressful circumstances. This will result in heightened stamina and endurance for athletic competition, the workplace and conditions of inclement environment and weather conditions.
With its ease of cultivation, there is hardly a reason that most people and certainly old age nursing homes does not have its own garden patch of ashwagandha as a hedge, so to speak, against the ravages of aging decrepitude. Given the fact that for better or worse, more people are living longer in the world than any other time in its history, trying to save enough money in long term retirement accounts for a comfortable old age and at the same time sensing real concerns at the thought of dwindling governmental entitlement benefits, it seems imperative that everyone grow their personal supply of ashwagandha and learn how to prepare and take it.
Besides over 3000 years of empirical experience, numerous studies on both animals and humans have attested to the anti-arthritis and mind calming properties of crude preparations of the herb. The combined alkaloids seem to exhibit calming, anti-convulsant and antispasmodic properties against many spasmogenic agents on the intestinal, uterine, bronchial, tracheal and blood-vascular muscles. It is described as similar but considerably weaker that papaverine and phenobarbitone  . Other constituents, namely the sitoindosides enhance pathogenic devouring phagocytes. Even anti-tumor properties have been found based on the use of the crude extract on mice both in living specimens as well as against cancer cells in the petri dish.
Ashwagandha is used in Ayurvedic medicine as a powder, decoction, medicated wine, mixed with clarified butter, combined with honey or sugar syrup or as a medicated oil. The most common form is as an alcoholic extract or capsules, of the powdered root.
Dosage is as follows:
Powder: 3-6 grams daily or up to 5 to 10 grams as an occasional tonic
Decoction: 16 to 31 grams added to heated cow’s milk
Alcoholic Extract: 2 Tblsp., 2-4 times daily.
Mixed with ghee or honey: 1 tsp. 2 times daily
Narayana Taila Oil: Internally, 3-10 drops; or freely applied externally to painful, arthritic joints.
Contraindications and Toxicity:
Large doses of ashwagandha may possess abortifacient properties so that it should not be taken drink pregnancy unless under the direction of an experienced health professional. It is also contraindicated in conjunction with sedatives or anxioletics (a substance that reduces anxiety) or if one is suffering from stomach ulcers. Traditionally, like other tonics such as ginseng, ashwagandha should not be taken when there are signs of inflammation or advanced arterial congestion. For this reason is may be best to precede or accompany taking it with a general detoxifying herb or formula such as Yogaraj guggul.
Ashwagandha is relatively safe when taken in the prescribed range of dosage.  Large doses, however, have been shown to cause gastrointestinal upset, diarrhea and vomiting. Finally, because ashwagandha has been found to potentiate the effects of barbituates, it is generally recommended that it be not taken under such conditions.
Ashwagandha according to the TCM model:
Because of its actions and flavors, ashwagandha would be classified as a Yang tonic with particular affinity for the Kidneys, because of its hormonal action, and the Heart, because of its ability to calm the mind and relieve anxiety and insomnia. As an anti-arthritis and antispasmodic, it has wind dispelling properties. Ashwaganda is used by herbalist Alan Tillotson and his Chinese herbalist wife, Naixin, for cases where ginseng is too stimulating or hot and the patient appears nervous and fragile. For fatigue caused by overwork without nervousness, he prefers to use Siberian ginseng.
Some Traditional and Non-Traditional Ayurvedic Combinations Using Ashwagandha are as Follows:
General Use: The root is taken in 30 gram dosage for general debility, consumption, mal -nourishment in children, senile debility, rheumatic and arthritic conditions, nervous exhaustion, fatigue, brain-gag, memory weakness, senile dementia, muscular weakness, spermatorrhea and leucorrhea. Normally this can be taken as a powder 10 grams three times daily mixed with warm milk or water, or as a one to 5 alcoholic extract, one or two tablespoonsful three times daily.
For insomnia, ashwagandha can be mixed with valerian root and oyster shell.
As a general nerve tonic, especially for hypoglycemia or low blood pressure, ashwagandha is combined with Goksura.
For chronic fatigue ashwagandha is combined with another great Ayurvedic tonic herb, shatavari (Asparagus racemosa), licorice, amla (emblica myrobalan) and multi-minerals, especially calcium and magnesium. If there is mild inflammation or low grade fevers Dr. Mana, a prominent Nepalese Ayurvedic doctor gives a separate formula to reduce inflammation along with the ashwagandha preparation.
For impotence it can be used alone or combined with fried Cow-hage seeds. The method is to remove the inside of the seeds and mix this with ashwagandha and ginger.
For weak lungs, ashwagandha is combined with Sida cordifolia (Bala).
Milk, to stimulate production: combine with equal parts Dioscorea batatas (also available as Shan Yao, a Chinese herb) and licorice and make a decoction of 30 grams of the mixture. Take three times daily.
Nerve tonic: combine with Goksura (Hygrophila spinosa) equal parts. This is especially good for hypoglycemia and low blood pressure.
Nutrition of malnourished children, Improving: Make a paste of the root with ghee and milk. Administer three times daily.
Skin diseases: Make a salve of ashwagandha or mix the powder with sesame oil and apply topically.
Sterility, Female: Boil a decoction of 30 grams in water down to half a cup, add mild and one tablespoon of ghee (clarified butter) and a teaspoon of honey. Take three times daily for two weeks after menstruation.
American Herbal Pharmacopoeia and Therapeutic Compendium, Ashwagandha Root Monograph, coordinated by herbalist Upton, Roy, President of the American Herbalist Guild, et al. 1996 (pending publication).
Arseculeratne, S.N. "Studies on Medicinal Plants of Sri Lanka Part 14: Toxicity of some Traditional Medicinal Herbs" Journal of Ethnopharmacology 13(3):323-35; 1985.
Atal, C.K.; Gupta O.P.; Raghunathan, K.; Dhar, K.L., "Pharmacognosy and Phytochemistry of Withania Somnifera", Central Council for Research in Indian Medicine and Homeopathy, New Delhi, 1975.
Bhatnagar, S.S.et al., eds, The Wealth of India: A Dictionary of Indian Raw Materials and Industrial Products. vol. 10. New Delhi: Publicity and Information Directorate, Council of Social and Industrial Research; 1976:582-585.
Bector, N.P., Puri, A.S., Sharma, D.; "Role of Withania somnifera (Ashwagandha) in various Types of Arthropathies", Indian Journal of Medical Research, 56, 10 October, 1968.
Bhattacharya, S.K et al. "Anti-Stress activity of Sitoindosides VII and VIII, New Acylsteryglucosides from Withania somnifera". Phytotherapy Research 1(1):32-37; 1987.
Kapoor, L.D. CRC Handbook of Ayurvedic Medicinal Plants, Boca Raton, FL:CRC Press, Inc.; 337-8; 1990
Karnick, C.R."A Double-Blind, Placebo-Controlled Clinical Study on the Effects of Withania somnifera and Panax Ginseng Extracts on Psychomotor Performance in Healthy Indian Volunteers." Indian Medicine 3(2,3):1-5; April-July, 1991.
Nadkarani, A.K., Indian Materia Medica, Bombay Popular Prakashan, vol. 1, pp. 1292-94; 1976.
Rao, Prabhu, M.Y., Karahth, K.S., "Neuropharmacological Activity of Withania Somnifera," Fitoterapia, Vol. LXI, No. 3; 1990.
Rahman, A.U., et al., "New Withanolides from Withania spp.," Journal of Natural Products, vol. 56, No. 7, pp. 1000-06; 1993.
Schwarting, A.E., et al., "The Alkaloids of Withania somnifera," Lloydia 26(4):258-73; 1963.
Shibnath, G., et al., "Immunomodulatory and CNS Effects of Sitoindosides IX and X, Two New Glycowithanolides from Withania Somnifera," Phytotherapy Research 3(5); 1989.
Subramanian, S. "Ashwagandha--An Ancient Ayurvedic Drug," Arogya-Journal Health Sciences VIII:135-39; 1982.
Wagner, H. et al. "Plant Adaptogens," Phytomedicine 1(1); 69-70; 1984.
 Grandhi, A., “Comparative pharmacological investigation of ashwagandha and ginseng”, Journal of Ethnopharmacology (Ireland), 1994: vol. 3, pp 131-135
 ”inane” because the most valuable herb is always the one that will be the most effective.
 Rinpoche, R. Tibetan Medicine, University of California Press; 1976: 14:15)
 Frawley, D,; Ayurvedic Healing, Passage Press, 1989: Introduction xv-xvi and Svobada, R.; Lade, A. Tao and Dharma: Chinese Medicine and Ayurveda, Lotus Press, 1995: 80-92.
 Dash, V.B., Junius, A.M. M., A Handbook of Ayurveda, Concept Publishing, New Delhi, 1983: 15-25
 Sharma, P.V., Introduction to Dravyaguna, i.e. Indian pharmacology; Chaukhambha Orientalia, Varanasi, India, 1976: 38-41)
 Bhatnagar et al., 1976 also Schwarting et al., 1963)
 Tierra, M., Planetary Herbology, 1988: 3-34; also Frawley, D., Lad, V., The Yoga of Herbs. Santa Fe: Lotus Press; 1986:28-35)
 Kuppurajan, K., et al. “Effects of Ashwagandha (Withania Somnifera Dunal) on the Process of Aging in Human Volunteers,” Journal of Research in Ayurveda and Saddai: 247-258, 1980
 Effect of Glycowithanolides from Withania somnifera on an Animal Model of Alzheimer's Disease and Perturbed Central Cholinergic Markers of Cognition in Rats
 Kulkarni, R.R., Treatment of osteoarthritis with a herbomineral formula: double-blind, placebo controlled, cross-over study, Journal of Ethnopharmacology (Ireland) Citation: 33 (1-2 1991):91-95
 Nadkarani, 1976)
 Upton, R. et. al, American Herbal Pharmacopoeia, 1996 (unpublished to date)
 Schwarting, 1963
 Brekhman, I.I., “Man and Biologically Active Substances”, The Effect of Drugs, Diet and Pollution on Health; Pergamon Press, 1980: 1-89
 Badmaev, M.D., Ph.D, Majeed, Muhammed, Ph.D., Ayurvedic Adaptogens and “Bioprotectants”, ?
 (Bhatnagar, 1976; Ral et al., 1983)
 When the entire plant was administered to mice as 25% of the diet, microscopic lesions were found in various organs including the liver and lungs along with vascular congestion and tubular congestion of the kidneys. Considering the widely recognized benefits of taking the herb, and that tonic dosage levels are not really comparable to its experimental administration to animals, it should be considered generally safe, especially when taken with other herbs (arseculaeatne, 1985)
Ashwagandha is one of the most revered plants in traditional Ayurvedic medicine in India. It is an erect, greyish, subshrub with inconspicuous yellow or greenish flowers followed by small, spherical, orangish-red berries containing yellow, kidney-shaped seeds. It grows three-to-five feet tall, mainly on waste land, but is cultivated widely as the whole plant; most commonly the root and leaf are used medicinally.1,2
The species is widely distributed in the northwestern Indian states of Gujarat, Madhya Pradesh, Maharashtra, Rajasthan, Uttar Pradesh, and the Punjab plains extending to the mountainous regions of Himachal Pradesh and Jammu.3 It also is cultivated in parts of Madhya Pradesh and Rajasthan.4 Northwest of India, its habitat extends into the Pakistani provinces of Sindh and Baluchistan, and on into Afghanistan. To the southeast of India, it occurs in Sri Lanka.5 In China, it is reported to grow in the western provinces of Gansu and Yunnan.6
HISTORY AND CULTURAL SIGNIFICANCE
The species name, somnifera, refers to ashwagandha’s use as a sedative.1 The common name comes from the Sanskrit ashvagandha,2,7 i.e., ashwa for horse, and gandha for smell, hence the common idea that the name means “smells like a horse.” The Ayurvedic health practitioner Vaidya R. K. Mishra states that the translation can be taken literally, or that it could be interpreted to mean “horse essence” and that ashwagandha provides the strength, character, essence, or stamina of a horse.8
Ashwagandha is the Bengali name and variations are used in Nepalese (aasogandha) and Japanese (aswangandha).2 Other common names include asgandh (Hindi), amukkara (Sinhalese), asgandh valaiti (Unani), bahman (Persian, Arabian), ba-dzi-gandha (Tibetan), kutilad (Pustu), amurkkuralckizhangu (Tamil), winter cherry (English), and blærebæger (Danish).2,9 It is sometimes erroneously called Ayurvedic or Indian ginseng, an incorrect appellation because it is not in the genus Panax or in the ginseng family, Araliaceae.10
Preparations of various plant parts have been credited with the following actions: abortifacient, adaptogenic, alterative, analgesic, antiarthritic, antiasthmatic, antibiotic, antidyspeptic, anti-inflammatory, antimitotic, antiproliferative, antitumor, aphrodisiac, astringent, bactericide, carminative, contraceptive, depurative, diuretic, emetic, febrifuge, fungicidal, hypnotic, immune-modulating, laxative, proteolytic, tonic, and nervine sedative.1,2,7,9,11 Additionally, it may have cytotoxic, chemopreventative, and radiosensitizing actions.9
Ashwagandha is one of the rasayana herbs in Ayurveda — one of the herbs that purportedly promotes youth and longevity and alleviates suffering.12 It is thought to be especially rejuvenative for men; to strengthen bone marrow, muscle, and semen; and to imbue the user with intellectual facility, in addition to long life and youthful vitality.1 However, it also is believed to be quite helpful to the elderly by providing energy and relieving pain, inflammation, and nervous debility.12
Ashwagandha has a wide variety of traditional uses, many of which have not been tested scientifically. Ethnobotanist James Duke, PhD, writes that ashwagandha (various plant parts) is a folk remedy for “adenopathy, anthrax, arthritis, asthma, bronchitis, cancer, candida, cold, cough, cystitis, debility, diarrhea, dropsy, dyspepsia, erysipelas, fever, furuncle, gynecopathy, hiccups, hypertension, inflammation, lumbago, marasmus, nausea, piles, proctitis, psoriasis, rheumatism, ringworm, scabies, senility, smallpox, sores, syphilis, tuberculosis, tumors, typhoid, uterosis, and wounds.”11 Additional uses attributed to the plant, in general, are the treatment of alcoholism, anemia, colds, dropsy, fever, hypertension, insomnia, lumbago, ulcers, wasting in children, and removal of obstructions in any human body system.1,7,9,12
Some of the documented uses of the root of ashwagandha include as a hypnotic for treating alcoholism (along with leaf); treatment for brain fog, colds and chills, childhood emaciation, emphysematous dysphonia (difficult speech caused by emphysema, with leaf), fever, glandular swelling, impotence or seminal debility; to increase breast milk; and to counteract loss of memory and muscular energy, nervous exhaustion, rheumatic fever, rheumatic swelling, senile and general debility, spermatorrhea, syphilis, and ulcers.2,7,11 In Tanzania, the root is used as a sexual stimulant and to promote uterine contractions.11
The leaves are used to expel worms and are combined with warm castor oil (Ricinis communis, Euphorbiaceae) on carbuncles, inflammations, and swellings.2,7,11 The Masai use the leaf juice for conjunctivitis.11 The fresh bruised berries are used on ringworm.2,11 The fruits or seeds are used to coagulate milk.2,7,11 The seeds also are used as a masticatory.11 A bark infusion is used in Lesotho internally for asthma and externally for bedsores.11 The tender shoots are eaten as a vegetable in India.11
The dried root and the whole plant are used in the traditional medicine systems of Ayurveda, Siddha, Sowa-Rigpa (Amchi), and Unani, as well as in Indian folk medicine. The materials of commerce are obtained from both cultivated and wild-collected sources, mainly in India.13
Although ashwagandha is now cultivated on farms outside of its native habitat, and the unprocessed dried roots are being used as components of dietary supplement products and natural health products, in the Indian systems of medicine, the dried roots may be subjected to certain traditional fermentation, purification, or detoxification processes prior to therapeutic use.14
There are W. somnifera standards monographs published in the Ayurvedic Pharmacopoeia of India (Vol. I, 1989),15 Siddha Pharmacopoeia of India (Vol. I, 2008),16 Unani Pharmacopoeia of India (Vol. I, 2007),17 the World Health Organization (WHO) Monographs (Vol. 4, 2009),18 as well as in the currently valid editions of the British Pharmacopoeia (BP 2012),19 Indian Pharmacopoeia (IP 2010),20 and United States Pharmacopeia (USP 36).21
CURRENT AUTHORIZED USES IN COSMETICS, FOODS, AND MEDICINES
In countries where the Ayurvedic system of medicine is officially recognized and practiced (e.g., India, Bangladesh, Bhutan, Malaysia, Nepal, and Sri Lanka), the powdered dried root of ashwagandha is used, as a component of preparations, for treating inflammatory disorders, phthisis (any wasting or atrophic disease, weakness, diseases due to vata dosha), and male impotence.15
In countries where the Unani system of medicine is officially recognized and practiced (e.g., Bangladesh, India, Malaysia, Pakistan, and Sri Lanka), the dried mature root, referred to as “asgand,” is used as a component of medicinal formulations to treat leucorrhoea, spermatorrhoea, decreased viscosity of semen, sexual debility, lumbago, and arthritis. Ashwagandha is often dispensed as a component of compound Unani medicines known as majoon or halwa. These preparations are made with prepared and powdered botanicals mixed with honey, resulting in a soft or semi-solid consistency like the popular confection halva.17
In Siddha medicine — a Dravidian system of medicine originating in the southeastern Indian state of Tamil Nadu, now also practiced in the neighboring states of Karnataka, Kerala, and Andhra Pradesh, as well as in parts of Malaysia, Singapore, and Sri Lanka — the dried root (purified before use), referred to as amukkara, is used as a component of formulations indicated for treatment of conditions including oligospermia, lancinating pain, loss of body strength, anemia, convulsions/seizures/fits, disordered humor, eczema, edema/swelling, and tuberculosis.22
In Canada, ashwagandha root is classified as an active ingredient of licensed natural health products (NHPs), requiring pre-marketing authorization from the Natural Health Products Directorate (NHPD) and manufacture in compliance with NHP Good Manufacturing Practices (GMPs). Authorized uses outlined in its NHPD compendial monograph include “traditionally used in Ayurveda as rasayana (rejuvenative tonic),” “traditionally used in Ayurveda to relieve general debility, especially during convalescence or old age,” “traditionally used in Ayurveda as a sleep aid,” “traditionally used in Ayurveda to balance aggravated Vata (nervine tonic, sedative),” and “traditionally used in Ayurveda for memory enhancement.”23
In the United States, ashwagandha is not listed as Generally Recognized as Safe (GRAS) in the Code of Federal Regulations (CFR) for any uses in conventional food products, nor does it appear in FDA’s GRAS Notice Inventory database. Ashwagandha is permitted, however, for use as a dietary supplement component, requiring FDA notification within 30 days of marketing a product (if a “structure-function” claim is made) and product manufacturing according to dietary supplement GMPs. USP has developed dietary supplement quality standards monographs for “Ashwagandha Root,” “Powdered Ashwagandha Root,” and for “Powdered Ashwagandha Root Extract.” These USP monographs are acceptable for use as dietary supplement component specifications and quality control testing to verify conformance to specification before use in a product.21
In the European Union (EU), ashwagandha is not subject to the Novel Food Regulation because it was on the market as a food or food ingredient and consumed to a significant degree before May 15, 1997. Other specific legislation, however, may restrict the placing of ashwagandha as a food or food ingredient on the market in some Member States.24
For example, in 2008, the Government of India, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) — as part of a global strategy for brand-building of Ayurvedic medicine — prioritized the promotion of ashwagandha preparations, in particular, for attaining marketing authorizations as medicinal products in several foreign markets including selected EU member states, as well as in Australia, Canada, and Commonwealth of Independent States (CIS) countries. The ashwagandha strategy was developed in collaboration with the International Trade Centre (ITC) of UNCTAD (Geneva, Switzerland).25
By 2010, the BP developed a quality standards monograph for the dried mature root of W. somnifera specifically for use in Traditional Herbal Medicinal Products (THMPs), as defined under the EU Traditional Herbal Medicinal Products Directive (THMPD).19 The BP monograph was an important first step that provided applicants with a requisite quality control specification, thus paving the way for the use of ashwagandha as an active ingredient of THMPs that could be authorized by the Medicines and Healthcare products Regulatory Agency (MHRA) for marketing in the United Kingdom.
In July 2011, the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) began the process of developing a labeling standards monograph (for use by applicants for the labeling of ashwagandha THMPs in the EU) by putting out a call for submission of scientific data that would be used in the assessment of W. somnifera radix as part of the establishment of Community herbal monographs and/or Community list entries.26
Following their assessment, in October 2012, the EMA issued a draft public statement with the opinion that a Community herbal monograph on W. somnifera radix could not yet be established because the HMPC had not been able to find adequate evidence allowing them to develop a description of ashwagandha preparations, i.e., insufficient extract specifications according to EU pharmaceutical quality requirements, despite the existence of data on uses within the EU of products containing W. somnifera radix. Additionally, the HMPC stated that they were unable to find evidence demonstrating the requirement of at least 30 years of medicinal use of ashwagandha preparations including at least 15 years in an EU member state.27 As of the time of this publication, there are still no known ashwagandha-containing THMPs with marketing authorization granted in any EU member state.
Concerning its use in cosmetic products, the European Commission Health and Consumers Directorate lists several defined W. somnifera ingredients (root powder, root extract, leaf and root extract, and flower extract) for skin-conditioning function (maintains the skin in good condition). “Withania somnifera leaf extract,” however, is approved for several functions in cosmetic products, including as an antimicrobial (helps control the growth of micro-organisms on the skin), antioxidant (inhibits reactions promoted by oxygen, thus avoiding oxidation and rancidity), bleaching (lightens the shade of hair or skin), emollient (softens and smoothes the skin), and humectant (holds and retains moisture).28
The main active chemical constituents in ashwagandha are steroid lactones (withaferin A, sitoindoside IX and X, [carbon-27 glycowithanolides], and acylsteryl glucosides [sitoindosides VII, VIII]); phytosterols; and alkaloids: tropane type (tropine and pseudotropine), plus isopelletierine, and anaferine.1,9
An open-label, prospective, non-randomized, comparative clinical study published in 2013 addressed the potential use of ashwagandha root extract powder (Himalaya Drug Co.; New Delhi, India) for the mitigation of fatigue caused by chemotherapy and for improving quality of life in patients with breast cancer.29 Patients undergoing chemotherapy for breast cancer were assigned alternately into the study group (n=50) or control group (n=50) and assessed for fatigue. The study group took 500 mg ashwagandha dry extract three times daily throughout six cycles of chemotherapy. The ashwagandha patients experienced less fatigue and better quality of life during chemotherapy than the control group.
In another 2013 clinical trial, three groups of infertile male patients were recruited from the infertility clinic at King George’s Medical University, Lucknow, India; 60 with normal semen profile and infertility of unknown etiology, 60 with low sperm count and normal morphology, and 60 with normal sperm count and normal morphology but reduced sperm motility.30 Controls were 50 age-matched men with normal semen profile who had initiated at least one pregnancy previously. Each patient in the study group took 5 g/day ashwagandha root powder (roots purchased from the Central Council for Research in Unani Medicine; New Delhi, India; dried in shade and ground to fine powder) orally in milk for three months. Semen samples were collected and centrifuged and the seminal plasma was assessed. Results showed that ashwagandha normalized markers in seminal plasma and may resolve infertility via action on metabolic, enzymatic, and hormonal pathways.
A 2010 prospective clinical study investigated the impact of ashwagandha on semen profile, oxidative biomarkers, and reproductive hormone levels in infertile men.31 The control group comprised normal healthy, fertile men (n=75) with normal semen profile who had initiated at least one pregnancy previously. The test groups comprised patients with infertility for more than one year (n=75; 25 with normal semen profile and infertility of unknown etiology, 25 with below-normal semen profile, and 25 with below-normal sperm motility). Patients with conditions known to influence oxidative stress were excluded from the study. For three months, the test group took 5 g/day ashwagandha root powder (Central Council for Research in Unani Medicine, New Delhi) orally with milk. Sperm concentration increased significantly in all three test groups after treatment. Sperm motility improved in all three groups but not significantly in the group with below-normal sperm motility. Semen volume increased significantly in all test groups except the group with below normal sperm motility. The ashwagandha also inhibited lipid peroxidation in the test groups, effectively reducing oxidative stress. Finally, the ashwagandha groups experienced increased serum testosterone and luteinizing hormone levels and reduced levels of follicle-stimulating hormone and prolactin — all indicators of semen quality.
A 2012 clinical study with a pilot arm and a therapeutic arm investigated the efficacy of ashwagandha as an adjunct therapy in treating tuberculosis.32 Recently diagnosed pulmonary tuberculosis patients who had yet to take any anti-tuberculor drugs (ATD) were enlisted. In the pilot study, Phase 1 patients took either ATD or ATD plus ashwagandha (Stresscom, standardized to 4.5% withanolides, Dabur Research Foundation; New Delhi, India). In Phase 2, patients took either ATD, ATD plus ashwagandha, or ATD plus the Ayurvedic multi-herb-and-fruit formulation Chyawanprash (Dabur Research Foundation; New Delhi, India). The treatment groups in the therapeutic study were the same as those in Phase 2 of the pilot study. More improvement was seen in both herbal adjunct groups than in the ATD-only group, including reduced bacterial counts after 26 days in the ashwagandha group and 29 days in the Chyawanprash group.
A 2012 single-arm, uncontrolled, observational, dose-response study assessed the safety, tolerability, and activity of escalating doses of ashwagandha.33 For 30 days, at 10-day intervals, 18 healthy participants took increasing doses of ashwagandha (8:1 pulverized ashwagandha root extract; source, preparation, and manufacturer not stated) starting with 250 mg in the morning and 500 mg in the evening (750 mg total/day) on days 1-10, 500 mg in the morning and 500 mg in the evening (1000 mg total/day) on days 11-20, and 500 mg in the morning and 750 mg in the evening (1250 mg total/day) on days 21-30. There were no significant changes in vital signs (blood pressure, pulse, body temperature, and respiration rate, taken at baseline and on days 11, 21, and 31), body weight, or blood markers during the study, nor were any significant changes in appetite, waste elimination habits, or sleep duration reported — although 33% of the subjects reported improved sleep quality. Muscle strength increased significantly and, although body weight and body mass index (BMI) did not change significantly, there was a trend toward increased lean body weight and decreased body fat percentage. Total cholesterol decreased significantly and decreasing trends were seen in fasting blood sugar, triglycerides, and LDL cholesterol.
A six-week clinical trial in 2012 evaluated the safety of an Ayurvedic formula used in the treatment of osteoarthritic knees.34 The formula (preparation and manufacturer not stated) contained ashwagandha root powder, ginger (Zingiber officinale, Zingiberaceae), Indian tinospora or guduchi (Tinospora cordifolia, Menispermaceae), and tribulus (Tribulus terrestris, Zygophyllaceae). The formula showed no serious adverse events and none of the participants withdrew due to any drug-related toxicity.
A 2010 uncontrolled clinical study assessed the efficacy of ashwagandha and arjuna (Terminalia arjuna, Combretaceae) alone and in combination on physical performance and cardiorespiratory endurance in healthy young adults.35 Of 40 subjects over the course of eight weeks, 10 received 500 mg/day standardized aqueous root extract of ashwagandha, 10 received 500 mg/day standardized aqueous bark extract of arjuna, and 10 received 500 mg/day both ashwagandha and arjuna extracts encapsulated together (all herbs provided by the Central Council for Research in Ayurveda and Siddha; Delhi, India). A control group of 10 participants received encapsulated flour. The ashwagandha group experienced increased velocity, power, and maximum oxygen consumption, while the arjuna group experienced increased maximum oxygen consumption and lowered resting systolic blood pressure. In combination, participants experienced improvement in all the parameters mentioned above. None of the groups experienced improved balance or diastolic blood pressure.
Two 2009 double-blind, pilot studies investigated ashwagandha and four other Ayurvedic herbs for their immune-enhancing effect.36 Study 1 included 32 volunteers randomized to two treatment groups of 16 each who consumed three cups daily of Natural Care tea (ashwagandha [0.5%]; licorice [Glycyrrhiza glabra, Fabaceae, 0.5%]; ginger [1.5%]; holy basil [Ocimum tenuiflorum, Lamiaceae, 0.5%]; and cardamom [Elettaria cardmomum, Zingiberaceae, 1.5%]; Hindustan Unilever Research Center; Bangalore, India) or regular tea (Camellia sinensis, Theaceae) for two months. Natural killer (NK) cell activity was measured after one and two months of tea consumption. There were no significant changes in either group at the end of month one, but NK cell activity was significantly increased after two months in the NC tea drinkers but not in the regular tea group.
Study 2 was a larger, double-blind, crossover study in which 110 subjects (60 male, 40 female [sic]) were randomly assigned to two groups.36 Each group consumed three cups of tea (Natural Care or regular tea) per day for two months. NK cell activity was measured before a 15-day washout period when no tea was drunk. The groups then switched to the other tea for another two months, after which NK cell activity was measured again. NK cell activity increased in both groups after two months, but the increase in the Natural Care tea drinking groups was approximately 4.2 times higher than before, while the NK cell activity in the regular tea group was about 2.9 times higher.
A randomized, controlled trial published in 2009 addressed the efficacy of ashwagandha for moderate-to-severe anxiety lasting more than six weeks per self-assessment.37 Participants were randomized to receive naturopathic care with ashwagandha (n=41), a multi-vitamin, dietary counseling, and cognitive-behavioral therapy, or standardized psychotherapy intervention (n=40). The ashwagandha group took 300 mg, two per day, for six weeks of ashwagandgha extract standardized to 1.5% withanolides from root obtained from Swiss Herbals (now Swiss Natural; Richmond Hill, ON, Canada). Outcomes were measured at four, eight, and 12 weeks, with the results suggesting that both treatments caused a significant reduction in anxiety, but the ashwagandha group also experienced significant improvement in quality of life, including reduction of stress, improved vitality, motivation, general health, and patient-specific concerns. The authors stated that it is difficult to assess the precise effect of each of the component therapies and that future studies should focus on isolating the effects of component therapies and use a blinded independent assessment rather than a patient-reported assessment.
A small, uncontrolled study assessed the immunologic effects of ashwagandha.38 Twice a day for 96 hours, five participants consumed 6 mL ashwagandha root liquid extract (grain ethanol and spring water extraction, Gaia Herbs; Brevard, NC) followed by 8 fl oz whole cow’s milk. Blood samples were taken at 0, 24, and 96 hours, and analyzed for immune cell activation. A significant change in immune cell activation occurred across the sample indicating that further study is warranted to determine if ashwagandha might be helpful in the prevention and treatment of infectious disease, cancer, and other immune-related conditions.
Bone and Mills (2013) reported on four studies between 1980 and 2008 that investigated ashwagandha for its tonic activity, a concept often misunderstood in Western medicine. Tonics are restorative, supportive, sometimes adaptogenic (i.e., helping the body to adapt to stressors) substances. In these studies, ashwagandha was found to significantly increase hemoglobin, red blood cell count, seated stature, and hair melanin content, as well as decrease serum cholesterol and erythrocyte sedimentation, improve men’s sexual performance, and counter decrease in nail calcium. It also improved alertness and state of awareness, responsiveness, sleep patterns, and physical capabilities of trainee mountaineers over a six-day trek with a 5,200 m (17,000 ft.) altitude gain; modestly improved muscle strength and muscle performance in healthy elderly men; and improved stress markers for chronically stressed patients.9
Of the estimated 960 medicinal plant species that form the source of 1,289 botanical raw drugs in trade in India, W. somnifera is among the top 117 species whose annual domestic consumption exceeds 100 metric tons (MT). Ranking at #4 in terms of volume, Indian domestic consumption of ashwagandha is estimated at 4,575 MT, of which about 24% relates to production by large herbal manufacturing units and about 76% by small and very small companies. Annual trade volume was estimated at between 2,000 to 5,000 MT in 2008. Much of the commercial supply is now produced by cultivation in Madhya Pradesh, Rajasthan, and parts of peninsular India.39
Although the Government of India’s strategy to promote Ayurvedic medicine to the world, initially focusing on ashwagandha as an emblematic Indian medicinal product, has not yet manifested as hoped — in part due to the EU regulatory framework, which makes it exceedingly complex, expensive, and almost impossible for even the larger Indian Ayurvedic medicine manufacturing companies to achieve marketing authorization for any non-European herbal medicinal products — ashwagandha-based products are taking hold in non-EU markets. The EU’s THMPD is viewed by Indian herbal medicine companies as a legislative market access barrier while entering the market in Commonwealth of Nations countries; in particular, entering Australia, Canada, Malaysia, and New Zealand has been less burdensome. Additionally, there are herbal companies situated in these countries interested in formulating new products that contain ashwagandha.
At the same time, some ashwagandha-containing Ayurvedic medicines are being labeled and marketed as food products, even in some EU member states. For example, the well-known Ayurvedic multi-herb tonic formulation Chyawanprash is available in the EU from several different Indian manufacturing companies. Some EU companies also are marketing products with food supplement labeling, for example Pukka Organic Ashwagandha vegetarian capsules (Pukka Herbs Ltd.; Bristol, England).
In the Australian market, at the time of this writing, there are 130 listed medicines that contain ashwagandha as an active ingredient.40 In the Canadian market there are presently 325 licensed NHPs that contain ashwagandha as a medicinal ingredient.41 In the United States, ashwagandha dietary supplement products are marketed by many of the major herbal brands.
—Gayle Engels and Josef Brinckmann
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17. Unani Pharmacopoeia Committee. The Unani Pharmacopoeia of India, Part I, Volume I, New Delhi, India: Government of India, Ministry of Health and Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). 2007;7-8.
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19. British Pharmacopoeia Commission. Withania Somnifera for use in THMP. In: British Pharmacopoeia 2012. London, UK: The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA). 2012.
20. Government of India Ministry of Health and Family Welfare. Indian Pharmacopoeia 2010. Ghaziabad, India: The Indian Pharmacopoeia Commission; 2010.
21. United States Pharmacopeia Convention. Ashwagandha Root; Powdered Ashwagandha Root; and Powdered Ashwagandha Root Extract. In: United States Pharmacopeia, 36th Revision (USP 36). Rockville, MD: United States Pharmacopeial Convention. 2013;1336-1341.
22. Siddha Pharmacopoeia Committee. Appendix 5.2 Cutti (Purification) of crude drugs. In: Siddha Pharmacopoeia of India, Part I, Vol. I, First Edition. New Delhi, India: Govt. of India, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). 2008;278-281.
23. Natural Health Products Directorate (NHPD). Monograph: Ashwagandha. Ottawa, Ontario: NHPD. April 18, 2007. Available at: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=35&lang=eng. Accessed July 4, 2013.
24. European Commission Health & Consumers Directorate. Novel Food Catalogue. Brussels, Belgium: European Commission. Available at:http://ec.europa.eu/food/food/biotechnology/novelfood/novel_food_catalogue_en.htm. Accessed July 4, 2013.
25. Basant S. Support to sustainable export development of Indian Ayurveda products [Letter to Josef Brinckmann, ITC Consultant]. New Delhi, India: Govt. of India, Ministry of Health and Family Welfare, Department of AYUSH. July 16, 2008.
26. Committee on Herbal Medicinal Products (HMPC). Call for scientific data for use in HMPC assessment work on Withania somnifera (L.) Dunal, radix. London, UK: European Medicines Agency (EMA). 15 July 2011. Available at: www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Call_for_data/2011/07/WC500109102.pdf. Accessed July 4, 2013.
27. Committee on Herbal Medicinal Products (HMPC). Public statement on Withania somnifera (L.) Dunal, radix. London, UK: European Medicines Agency (EMA). 20 November 2012. Available at:www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2012/12/WC500136129.pdf. Accessed July 4, 2013.
28. European Commission Health & Consumers Directorate. Cosmetic Ingredients and Substances (CosIng®) Database. Brussels, Belgium: European Commission. Available at:http://ec.europa.eu/consumers/cosmetics/cosing/. Accessed July 4, 2013.
29. Biswal BM, Sulaiman SA, Ismail HC, Zakaria H, Musa KI. Effect of Withania somnifera on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients. Integr Cancer Ther. 2013;12(4):312-322.
30. Gupta A, Mahdi AA, Shukla KK, et al. Efficacy of Withania somnifera on seminal plasma metabolites of infertile males: a proton NMR study at 800 MHz. J Ethnopharmacol. June 21, 2013 doi:pii: S0378-8741(13)00444-3. 10.1016/j.jep.2013.06.024. [Epub ahead of print].
31. Ahmad MK, Abbas AM, Shukla KK, et al. Withania somnifera improves semen quality by regulating reproductive hormone levels and oxidative stress in seminal plasma of infertile males. Fertility and Sterility. August 2010;94(3):989-996.
32. Raut AA, Rege NN, Tadvi FM, et al. Exploratory study to evaluate tolerability, safety, and activity of ashwagandha (Withania somnifera) in healthy volunteers. J Ayurveda Integr Med. July 2012;3(3):111-114.
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