ASHWAGANDHA - WITHANIA SOMNIFERA

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

• Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

February 25, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)	Preparation
Withania somnifera	Asgandh Ashwagandha Asvagandha Winter-cherry Withania	Withania somnifera	Root	Dried

References: Proper name: USDA 2018; Common names: API 2001, McGuffin et al. 2000; Source material: API 2001.

Route of Administration

Oral (API 2001)

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) (Sukh Dev 2006; API 2001; Upton 2000).
• Traditionally used in Ayurveda to relieve general debility, especially during convalescence or old age (API 2001; Kapoor 2001).
• Traditionally used in Ayurveda as a sleep aid (Khare 2004; Upton 2000).
• Traditionally used in Ayurveda to balance aggravated Vata (nervine) (Kapoor 2001; Khory and Katrak 1999; Nadkarni 1954).
• Traditionally used in Ayurveda for memory enhancement (Sukh Dev 2006; Upton 2000; Nadkarni 1954).
• Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress) (Winston and Maimes 2007; Bone 2003; Williamson 2002).

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Ayurveda as a sleep aid and to balance aggravated Vata (nervine) (Khare 2004; Kapoor 2001; Upton 2000; Khory and Katrak 1999; Nadkarni 1954.

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Traditional Ayurvedic Claims

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

2 - 6 grams of dried root, per day (Williamson 2002; API 2001; Kapoor 2001; Nadkarni 1954).

Adaptogen

Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

2.5 - 6.5 grams of dried root, per day (Winston and Maimes 2007; Bone 2003; Williamson 2002).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep Aid

Consult a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002; Dipiro et al. 2002).

All Uses

• Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding (Upton 2000; McGuffin et al. 1997).
• Avoid taking with alcohol or products that cause drowsiness (Berardi et al. 2002; Gennaro et al. 2000; McGuffin et al. 1997).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness (Berardi et al. 2002).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

• API 2001: The Ayurvedic Pharmacopoeia of India, Part I, Volume I, 1st edition. New Delhi (India): Government of India, Ministry of Health and Family Welfare, Department of Indian Systems of Medicine & Homoeopathy; 2001.
• Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA and Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
• Bone K. A clinical guide to blending liquid herbs: Herbal formulations for the individual patient. St. Louis (MI): Churchill Livingstone; 2003.
• Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A pathophysiologic approach. 5th edition. New York (NY): The McGraw-Hill Companies, Inc.; 2002.
• Gennaro AR, editor. Remington: The Science and Practice of Pharmacy, 20th edition. Baltimore (MD): Lippincott Williams and Wilkins; 2000.
• Kapoor LD. Handbook of Ayurvedic Medicinal Plants: Herbal Reference Library. Boca Raton (FL): CRC Press; 2001.
• Khare CP. Indian Herbal Remedies: Rational Western Therapy, Ayurvedic and Other Traditional Usage, Botany. New York (NY): Springer; 2004.
• Khory RN, Katrak NN. Materia Medica of India and Their Therapeutics. Delhi (India): Komal Prakashan; 1999.
• McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press, LLC; 1997.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
• Nadkarni AK, Nadkarni KM. India Materia Medica with Ayruvedic, Unani-Tibbi, Siddha, Allopathic, Homeopathic, Naturopathic & Home Remedies, Volume 1, 3rd edition. Bombay (India): Popular Book Depot; 1954.
• Sukh Dev. Prime Ayurvedic Plant Drugs. Tunbridge Wells (UK): Anshan; 2005.
• Upton R, editor. American Herbal Pharmacopoeia and Therapeutic Compendium: Ashwagandha Root (Withania somnifera) - Standards of Analysis, Quality Control, and Therapeutics. Santa Cruz (CA): American Herbal Pharmacopoeia; 2000.
• USDA 2018: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN), Withania somnifera. National Germplasm Resources Laboratory, Beltsville, Maryland (MD). [Accessed 2018 December 17]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=102407
• Williamson EM, editor. Major Herbs of Ayurveda. London (UK): Churchill Livingstone; 2002.
• Winston D, Maimes S. Adaptogens: Herbs for strength, stamina and stress relief. Rochester (VT): Healing Arts Press; 2007.