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Drugs and Health Products

KUTKI - PICRORHIZA KURROOA

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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

October 30, 2018

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(s)

Picrorhiza kurrooa

  • Kutki
  • Picrorhiza

Picrorhiza kurrooa

  • Root
  • Rhizome

Dried

References: Proper name: USDA 2018; Common names: USDA 2018, API 2001; Source materials: WHO 2009, Duke et al. 2002, Williamson 2002.

Route of Administration

Oral

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

  • Traditionally used in Ayurveda as a bitter tonic to help stimulate appetite and aid digestion (stomachic) (Williamson 2002; API 2001; Kapoor 2001).
  • Traditionally used in Ayurveda as a hepatoprotectant/liver protectant (Williamson 2002; Kapoor 2001).
  • Traditionally used in Ayurveda as a laxative for the relief of occasional constipation (Sudarshan 2005; API 2001; Kapoor 2001).

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

  • Traditionally used in Ayurveda as a bitter tonic to help stimulate appetite and aid digestion and as a laxative for the relief of occasional constipation (Sudarshan 2005; Williamson 2002; API 2001; Kapoor 2001).

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)

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

Bitter tonic; Liver protectant

1-3 grams of dried rhizome/root, per day (WHO 2009; API 2001)

Laxative

1.5-3 grams of dried rhizome/root, per day (Paranjape 2005)

Direction(s) for use

No statement required.

Duration(s) of Use

Laxative

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days (Pray 2006; CPhA 2002; HC 1994).

Risk Information

Caution(s) and warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician if you have or develop abdominal pain, nausea, fever, vomiting or diarrhea (Williamson 2002; Kapoor 2001).

Bitter tonic; Laxative

Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

All products

Do not use this product if you are pregnant or breastfeeding (Brinker 2010).

Known adverse reaction(s)

Bitter tonic; Liver protectant

Laxative effect may occur (Sudarshan 2005; API 2001; Kapoor 2001).

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.
  • Picrorhiza kurrooa is listed in Appendix II of the Convention on International Trade of Endangered Species of Wild Fauna and Flora (CITES). This species is protected under Canada's Wild Animal and Plant Protection and Regulation of International and Interprovincial Trade Act (WAPPRIITA) and its Regulations (GC 2013). Please ensure the required CITES import/export permit accompanies each shipment. For more information, see http://www.cites.ec.gc.ca/eng/sct3/sct3_4_e.cfm (EC 2012).

References Cited

  • API 2001: The Ayurvedic Pharmacopoeia of India. Part I, Volume II, First Edition. Delhi (IN): The Controller of Publications; 1991. [Accessed 2018 August 14]. Available from: http://www.ayurveda.hu/api/API-Vol-2.pdf
  • Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts with Medicines, expanded 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • CPhA 2002: Repchinsky C, editor-in-chief. Patient Self-Care: Helping Patients Make Therapeutic Choices. 1st edition. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Duke JA, Bogenschutz-Godwin MJ, duCellier J, Duke PK. Handbook of Medicinal Herbs.2nd edition. Boca Raton (FL): CRC Press; 2002.
  • HC 1994: Laxatives: General - Laxatives - Labelling Standard [Internet]. Ottawa (ON): Drugs and Health Products; Health Canada; 1994. [Accessed 2018 August 14]. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/laxat-eng.pdf
  • Kapoor LD. Handbook of Ayurvedic Medicinal Plants. Baton Roca (FL): CRC Press LLC; 2001.
  • Paranjpe P. Indian Medicinal Plants: Forgotten Healers: A Guide to Ayurvedic Herbal Medicine. Delhi (IN): Chaukhamba Sanskrit Pratishthan; 2005.
  • Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
  • Sudarshan SR. Encyclopaedia of Indian Medicine, Materia Medica-Herbal Drugs.Volume 4.Banglore (IN): Popular Prakashan; 2005.
  • USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Picrorhiza kurrooa Royle ex Benth. Last updated 2003 March 05; Accessed 2018 August 14]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • WHO 2009: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 4. Geneva (CH): World Health Organization; 2009.
  • Williamson EM, editor. Major Herbs of Ayurveda. Edinburgh (GB): Churchill Livingstone; 2002.

References Reviewed

  • Ansari RA, Tripathi SC, Patnaik GK, Dhawan BN. Antihepatotoxic properties of picroliv: an active fraction from rhizomes of Picrorhiza kurrooa. Journal of Ethnopharmacology 1991;34: 61-68.
  • CITES . Convention on International Trade in Endandered Species of Wild Fauna and Flora. March 3, 1973. [Accessed 2014 June 27]. Available from: http://www.cites.org/
  • Lupper S. A Review of Plants Used in the Treatment of Liver Disease: Part 1. Alternative Medicine Review 1999;3(6):410-421.
  • MHFW 2007: Ministry of Health and Family Welfare, Monograph on Popular and Effective Select Traditional Home Remedies. [Internet]. Department of Ayush, New Delhi, In collaboration with WHO Country office for India. 2006-2007:30. [Accessed 2014 June 11]. Available from: http://fr.scribd.com/doc/162277056/Traditional-Medicine-Monograph-onPopular-Home-Remedies
  • Nadkarni AK. Dr. KM Nadkarni's Indian Materia Medica, With Ayurvedic, Unani-Tibbi, Siddha, Allopathic, Homeopathic, Naturopathic & Home Remedies, Appendices & Indexes, Volume One. Bombay Popular Prakashan;1976.
  • Saraswat B, Visen PKS, Parnaik GK, Dhawan BN. Ex vivo and in vivo investigations of picroliv from Picrorhiza kurroa in an alcohol intoxication model in rats. Journal of Ethnopharmacology 1999;66:263-269.
  • Shetty SN, Mengi S, Vaidya R, Vaidya ADB. A study of standardized extracts of Picrorhiza kurroa Royle ex Benth in experimental nonalcoholic fatty liver disease. Journal of Ayurveda Integrative Medicine 2010;1(3):2013-2010.
  • Shukla B, Visen PKS, Patnaik GK, Dhawan BN. Choleretic Effect of Picroliv, the Hepatoprotective Principle of Picrorhiza kurroa. Planta Medica 1991;57:29-33.
  • Vaidya AB, Antarkar DS, Doshi JC, Bhatt AD, Ramesh VV, Vora PV, Perissond DD, Baxi AJ, Kale PM. Picrohiza kurroa (Kutaki) Boyle ex Benth as a hepatoprotective agent - experimental & clinical studies. Journal of Postgraduate Medicine 1996;42(4):105-108.