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Tests a. Foreign organic matter: Not more than 2.0 per cent. b. Ethanol – soluble extractive: Not less than 10.0 per cent c. Water – soluble extractive: Not less than 15 per cent d. Ash: Not more than 7.0 per cent e. Acid – insoluble ash: Not more than 1.2 per cent f. Heavy metals: 1.0 g. g. Loss on drying: Not more than 12.0 per cent, determined on 5 g by drying in an oven at 105° h. Microbial contamination: Complies with the microbial contamination tests. i. Assay: Ashwagandha contains not less than 0.02 per cent of total withanolide A and withaferin A, calculated on the dried basis. 3. EFFICACY & SAFETY OF ASHWAGANDHA i. History and Uses The drugs derived from the plant kingdom have been used to alleviate or cure human diseases since ages. Ashwagandha is one such traditional ancient plant whose roots have been employed as a valuable drug in Indian traditional systems of medicine Ayurveda, Siddha and Unani. Ashwagandha is given the name ‘Indian Ginseng’ mainly because of its aphrodisiac and restorative properties. 1 Ashwagandha (Withania somnifera) is well known for its medicinal properties since the time of Puranvasu Atreya, an ancient scholar who taught medicine at Taxila university about 1000 BC and mentioned numerous medicinal uses of Ashwagandha. Ayurvedic Texts including Charak Samhita, Sushrut Samhita and Astang Hridaya and Bhav- Prakasha mention Ashwagandha to be general tonic as well as a cure of morbidity arising from diseases such as pain, arthritis and inflammation. Ashwagandha has been described as one of the components of the Balya (Tonics), Brimhaneeya (Weight promoting drugs) and Madhurskandha by Charaka (Su. 4/2.7; V. 8/139). Ancient authentic Ayurvedic Text books like Kaiyadeva Nighantu and Madanpal Nighantu have referred Ashwagandha for its properties and uses. It was used in many tonic preparations as prescribed by Chakradutta and others and was a major constituent of aphrodisiac formulations. Ashwagandha mixed with honey and butter was recommended for sexual debility. The plant was first mentioned in the English language texts by Van Rheede who called it ‘Pevetti’. 1 The uses and properties of the roots of Ashwagandha (Withania somnifera) are mentioned in various texts. In the Pharmacopoeia of India, the root of Ashwagandha are used in rheumatism and dyspepsia. 1 The roots are astringent, bitter, thermogenic, stimulant, aphrodisiac, diuretic and tonic. They are useful in leucoderma, constipation, insomnia, lumbar pain, nervous disorders, asthma, cardiac disorders, ulcers, carbuncles, scabies, marasmus of children, senile debility. 2 It is mainly indicated in the treatment of Sosha (Malnutrition), Sukra dosa (Defects of Semen), Vata vyadhi (Nervine Diseases), Unmada (Mental Diseases) and Apasmara (Epilepsy). 1 ii. Folk Lore Uses of Ashwagandha 1 In the foot hills of western Himalaya region, the root powder of Withania somnifera is used in pulmonary tuberculosis. The root paste is used in the info Ayurveda, Volume 2, No.5, July - Sept’ 2013 treatment of glandular swelling of bubonic plague. In Madhya Pradesh, the drug (root) is used for toning up uterus of women who habitually miscarry. The berries and seeds are given in chest complaints. The parts of Ashwagandha are heated and applied to painful joints and boils by the Meo community of Gurgaon district in Haryana. The tribal people of Eastern Rajasthan use Ashwagandha for treatment of lumbago, rheumatism and asthma. In Mysore district the crushed berries along with the juice of castor plant are drunk in cases for relieving the poison of serpent. In Tibet, powder of the roots is used as general tonic in seminal diseases as a nervine tonic. iii. Reference available in published Ayurvedic literature about Ashwagandha • Charak Samhita, Sutrasthanam 5 Ashwagandha has been referred as one of the bulk promoters. • Charak Samhita, Vimanasthanam 5 Ashwagandha is refered in Madhurskandha (Sweet Group) and a preparation of it with milk is described in various disorders. • Bhavprakash Nighantu, Guduchyadi Varga 6 Ashwagandha is referred as Balkarak (Strength Promoter), Sukravardhak (Increases Semen), Rasayana (Rejuvenating agent), Sotha (Inflammation) and Ksaya nashak (Anti –Tubercular). • The Ayurvedic Pharmacopoeia of India 2 Ashwagandha is described to have actions as Balya (Strength Promoter), Rasayana (Rejuvenating agent), Vajikarana (Aphrodisiac). It is having therapeutic uses in Ksaya (Tuberculosis), Daurbalya (Weakness), Vataroga (Neurological Disease), Sotha (Inflammation) and Klaibya (Male Impotence) • Kaiyadeva Nighantu 7 Ashwagandha is described as Sukra vardhak (Increases Semen), Bala karak (Strength Promoter), Rasayana (Rejuvenating agent, Pushtikarak (Provides nourishment). The therapeutic uses in Ksaya (Tuberculosis), Kasa (Cough), Vrana (Ulcer), Sopha (Oedema), Kandu (Itching), Vish (Poison), Krimi (Helminthiasis/Worm infestation), Swasa (Dyspnoea/Asthma) and Ksata (Wound). • Madanpal Nighantu 8 iv. Ashwagandha is used in treating Sotha (Inflammation), Kshaya (Tuberculosis) and acts as Strength Promoter and Rasayana (Rejuvenating agent). Concurrent use of Ashwagandha Ashwagandha (Withania somnifera) is used in varied number of formulation in Ayurveda, both in Patent & Proprietary and other textual medicines. The herb has been widely used in a diverse number of conditions for hundreds of years, in India. It is evident from the below mentioned formulations indicated in different health conditions – • Drakshadi Prayogati 9 Ashwagandha has been mentioned as an ingredient of a formulation stated as strength promoting and indicated in general weakness, 10
urinary stones and hemorrhagic diseases. • Mahasarasvati Churnam 10 Used as main ingredient in the formulation indicated as a memory enhancer. • Masatailam (Brhat) 11 One of the ingredients of the formulation indicated for the treatment of paralytic conditions. • Bhujangi Gutika 12 The formulation containing Ashwagandha has been mentioned in this text. It is indicated for the treatment of all types of nervous afflictions (Vatavyadhi) • The Ayurvedic Formulary of India 13 AFI, published by Government of India, Ministry of Health and Family welfare, Department of Indian Systems of Medicine & Homoeopathy, New Delhi has indexed many formulations containing Ashwagandha as one of the ingredient. Few formulations among those as mentioned in the AFI part I and II are given below in table 1 - Table 1: Different formulation in which Ashwagandha is used alongwith its usage S.No Preparation / Formulation Percentage of Ashwagandha (Approx) Dosage Form Use 1 Asvagandhadyarista 1.93% Liquid Syncope (Murccha), Epilepsy (Apasmara), Cachexia (Sosa), Digestive impairement (Agnimandya), Neurological Disorder (Vatavyadhi) 2 Balarista 6.45% Liquid Digestive impairement (Agnimandya), Weakness (Daurbalya), Neurological Disorder (Vatajroga), Cachexia (Karshya) 3 Asvagandhadi Lehya 5.53 % Paste 4 Guducyadi Modaka 1.07% Tablet 5 6 Maha Rasnadi Kvatha Churna Trayodasanga Guggulu Cachexia (Krsatva), Disorders of Blood (Raktavikara), Rejuvinator (Rasayana), Balya (Strength Promoter), Vajikarana (Aphrodisiac) Dysuria (Mutrakrichha), Mutraghata (Urinary Obstruction), Pthisis (Ksaya), Bleeding disorders (Raktapitta) 1.33% Powder Rheumatism, Tremors, Diseases of female genital tract 7.14% Pills Katigraha, Grdhrasi, Hanugraha, Asthivata, Hrtgraha, Yanidosa, Asthibhagna, Khanja vata 7 Dadhika Ghrta 1.13% Ghee 8 Phala Ghrta 1.20% Ghee 9 Prameha Mihira Taila 1.26% Oil Epilepsy (Apasmara), Mania /Psychosis (Unmada), Vata roga, Udara roga, Grahani, Anaha, Arsa Diseases of Children (Bala roga), Specific Disorders of Children (Bala graham), Disorders of semen (Sukra vikara), Disorder of female genital tract (Yoni vikara), Infertility (Vandhyatva), Disease during pregnancy (Garbhini roga), Emaciation (Karsya) Neurological Diseases (Vata vyadhi), Intermittent Fever (visama Jvara), Urinary Disorder (Prameha), Dhvajabhanga, Burning sensation (Daha), Thirst (Pipasa), Emesis (Chardi), Dryness of mouth (Mukha sosa) 10 Balaguduchyadi tail 0.95% Oil Gout (Vataraktaa) 11 Masabaladi Kvatha curna 14.28% Powder Paralysis/Hemiplegia (Paksaghata), Neck Rigidity (Manyastambha), Tinnitus (Karnanada), Ear ache (Karnaruja) 12 Brhat Asvagandha Ghrta 55.84% Ghee Oligospermia (Ksinasukra), Loss of muscle mass (Hinamamsa), Infertility (Vandhyatva), Cataract (Timira), Neurological Disorder (Vatavyadhi), Pthsis (Ksaya), Cough (Kasa), Asthma (Svasa), Hiccup ( Hikka), Intermittent Fever (Visama Jvara), 13 Sarasvata Curna 8.33% Powder Epilepsy (Apasmara), Mania/Psychosis (Unmada) 14 Ashvagandha Taila 53.09% Oil 15 Mahalaksadi Taila 2.31% Oil Neurological Disorder (Vataroga), Bleeding Disorder (Raktapitta), Menorrhagia/ Metrorrhagia or both (Asrgdara), Disorder of Female Genital Tract (Yonivikara), Mamsa Ksaya (Emaciation of Muscle) Fever (Jvara), Intermittent Fever (Visama Jvara),Cough (Kasa), Asthma (Svasa), Coryza (Pratisaya), Itching (Kandu), Lower Backache (Katisula) 16 Asvagandhadi Churna 21.77% Powder Tridosaksaya info Ayurveda, Volume 2, No.5, July - Sept’ 2013 11
Page 1 and 2: Volume 2, No.5, July to September
Page 3 and 4: Regulatory Update REGISTRATION OF C
Page 5 and 6: GOOD CLINICAL PRACTICE GUIDELINES F
Page 7 and 8: STORAGE Store in a cool place in ti
Page 9: BRIEF REVIEW ON ASHWAGANDHA (Withan
Page 13 and 14: Double Blind Randomized Placebo Con
Page 15 and 16: 3.6. TOLERANCE The drug was well to

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