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Monograph: Holy Basil - Ocimum Tenuiflorum - Leaf

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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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

September 29, 2015

Proper name(s)

Ocimum tenuiflorum L. (Lamiaceae) (USDA 2007; McGuffin et al. 2000)
Synonym: Ocimum sanctum L. (ITIS 2011, McGuffin et al. 2000, API 1999)

Common name(s)

  • Holy basil (USDA 2007; McGuffin et al. 2000)
  • Sacred basil (USDA 2007; McGuffin et al. 2000)
  • Tulasi (McGuffin et al. 2000; API 1999)
  • Tulsi (USDA 2007; McGuffin et al. 2000; API 1999)

Source material(s)

Leaf (API 1999; Agrawal et al. 1996)

Route(s) of administration

Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:
  • Traditionally used in Ayurveda (as an expectorant and/or demulcent) to help relieve cough (Kasa) and colds (Premila 2006; Paranjpe 2005; Sudarshan 2005; Mishra 2004; Williamson 2002; Kapoor 2001; Gogte 2000; API 1999; Jain 1991).
  • Traditionally used in Ayurveda (as an expectorant) to help relieve respiratory catarrh (Premila 2006; Paranjpe 2005; Sudarshan 2005; Mishra 2004; Williamson 2002; Kapoor 2001; Gogte 2000; API 1999; Jain 1991).
  • Traditionally used in Ayurveda as a cardiotonic (Hrdya) (Paranjpe 2005; Sudarshan 2005; Murthy 2004; Warrier 2003; Williamson 2002; Gogte 2000; API 1999).
  • Traditionally used in Ayurveda to aid digestion (Dipani) and stimulate appetite (stomachic) (Paranjpe 2005; Murthy 2004; Warrier 2003; Kapoor 2001; Gogte 2000; API 1999; Khory 1999; Jain 1991).
  • Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (in case of mental and physical fatigue related to stress) (McIntyre 2011; Winston and Maimes 2007; Hoffman 2003; Williamson 2003).
  • Source of/Provides antioxidants (Hakkim et al. 2007; Winston and Maimes 2007; Williamson 2003).
Note
A claim for traditional use must include the term "Herbal Medicine" or "Ayurvedic Medicine/Ayurveda".

Dose(s)

Statement(s) to the effect of:

Subpopulation(s)

Adults (≥ 19 years)

Quantity(ies)

Ayurveda
Decoction, infusion, and non-standardized aqueous extract:
7 - 28 g dried leaf, per day (Williamson 2002; Kapoor 2001).

Adaptogen
Decoction, infusion, and non-standardized aqueous extract:
4.2 - 28 g dried leaf, per day (Winston and Maimes 2007; Williamson 2002; Kapoor 2001).

All claims
Powder, extract dry, extract liquid, fluid extract, tincture:
2 - 3 g dried leaf, per day (API 1999).

Antioxidant
Decoction, infusion, and non-standardized aqueous extract:
Not to exceed 28 g dried leaf, per day (Williamson 2002; Kapoor 2001).

Powder, extract dry, extract liquid, fluid extract, tincture:
Not to exceed 3 g dried leaf, per day (API 1999).

Duration of use

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

All products:
  • If you are breastfeeding, consult a health care practitioner prior to use (WHO 2002).
  • If you are taking any heart or blood pressure medication, consult a health care practitioner prior to use (Rai et al. 1997; Agrawal et al. 1996).
  • If you have a heart condition or diabetes, consult a health care practitioner prior to use (Rai et al. 1997; Agrawal et al. 1996).
Relief of cough and Digestive aid:
If symptoms persist or worsen, consult a health care practitioner.

Contraindication(s)

If you are pregnant, do not use this product (Prakash et al. 2005; Ahmed et al. 2002; WHO 2002; Wohlmuth 2002; Kapoor 2001).

Known adverse reaction(s)

No statement is required.

Non-medicinal ingredients

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

Specifications

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

References cited

  • Agrawal P, Rai V, Singh RB. Randomized placebo-controlled, single blind trial of holy basil leaves in patients with noninsulin-dependent diabetes mellitus. International Journal of Clinical Pharmacology and Therapeutics 1996;34(9):406-409.
  • Ahmed A, Ahamed RN, Aladakatti RH, Ghoseawar MG. Reversible antifertility effect of benzene extract of Ocimum sanctum on sperm parameters and fructose content in rats. Journal of basic and clinical physiology and pharmacology 2002;13:51-59.
  • API 1999: The Ayurvedic Pharmacopoeia of India. 1st edition, Part I, Volume I. Delhi (IN): The Controller of Publications; 1999.
  • Gogte VVM. Ayurvedic Pharmacology and Therapeutic Uses of Medicinal Plants. Mubai (IN): Bharatiya Vidya Bhavan; 2000.
  • Hakkim FL, Shankar CG, Girija S. Chemical Composition and Antioxidant Property of Holy Basil (Ocimum sanctum L.) Leaves, Stems, and Inflorescence and Their in Vitro Callus Cultures. Journal of Agricultural and Food Chemistry 2007;55(22):9109-9117.
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • ITIS 2013: Integrated Taxonomic Information System [Internet]. [Last updated: 2013 March 8; Accessed 2013 March 22]. Available from: http://www.itis.gov
  • Jain SK. DeFillips RA. Medicinal Plants of India. Volume 1. Algonac (MI): Reference Publications, Inc; 1991.
  • Kapoor LD. Handbook of Ayurvedic Medicinal Plants. Baton Roca (FL): CRC Press LLC; 2001.
  • Khory RN, Katrak NN. Materia Medica of India and their Therapeutics. Delhi (IN): Komal Prakashan; 1999 [Reprint of 1903 publication].
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • McIntyre A. Le guide complet de la phytothérapie. Paris (FR) : Le Courrier du Livre; 2011.
  • Mishra LC, editor. Scientific Basis for Ayurvedia Therapies. Baton Roca (FL): CRC Press LLC; 2004.
  • Murthy KRS. Bhavaprakasa of Bhavamisra. Volume 1. Varanasi (IN): Chowkhamba Krishnadas Academy; 2004.
  • Paranjpe P. Indian Medicinal Plants: Forgotten Healers: A Guide to Ayurvedic Herbal Medicine. Delhi (IN): Chaukhamba Sanskrit Pratishthan; 2005.
  • Prakash P, Gupta N. Therapeutic uses of Ocimum sanctum Linn (Tulsi) with a note on eugenol and its pharmacological actions: A short review. Indian Journal of Physiology and Pharmacology 2005;49(2):125-131.
  • Premila MS. Ayurvedic herbs: A clinical guide to the healing plants of traditional Indian medicine. New York (NY): The Haworth Press Inc; 2006.
  • Sudarshan SR. Encyclopaedia of Indian Medicine, Materia Medica - Herbal Drugs. Volume 4. Banglore (IN): Popular Prakashan; 2005.
  • Rai V, Iyer U, Mani UV. Effect of Ocimum sanctum leaf powder on blood lipoproteins, glycated proteins and total amino acids in patients with non-insulin-dependent diabetes mellitus. Journal of Nutritional and Environmental Medicine. 1997;7(2):133-118.
  • USDA 2007: ARS, National Genetic Resources Program. Next link will take you to another Web site Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Ocimum tenuiflorum L. Last updated: 29-Oct-2007; Accessed 2012 July 27].
  • Warrier PK, Nambiar VPK, Ramankutty C, editors. Indian Medicinal Plants: a compendium of 500 species. Volume 4. Chennai (IN): Orient Longman Private Limited; 2003.
  • WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.
  • Williamson EM, editor. Major Herbs of Ayurveda. Edinburgh (GB): Churchill Livingstone; 2002.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.
  • Winston D, Maimes S. Adaptogens: Herbs for strength, stamina and stress relief. Healing Arts Press; Rochester (VT); 2007.
  • Wohlmuth H. Sacred basil - an Ayurvedic adaptogen. Botanical Pathways, 2002; Issue 11.

References reviewed

  • American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
  • Bhattacharyya D, Sur TK, Jana U, Debnath PK. Controlled programmed trial of Ocimum sanctum leaf on generalized anxiety disorders. Nepal Medical College Journal 2008;10(3):176-179.
  • Bradley P. British Herbal Compendium - A handbook of scientific information on widely used plant drugs. (Volume 2) Bournemouth (GB): British Herbal Medicine Association; 2006.
  • Brinker F. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Brinker F. 2010. Next link will take you to another Web site Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition. including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 February 01].
  • Brinker F. The Toxicology of Botanical Medicines. Sandy, Oregon: Eclectic Medical Publications; 2000.
  • Next link will take you to another Web site Dr. Duke's Phytochemical and Ethnobotanical Databases. [Accessed 2013 February 19].
  • Next link will take you to another Web siteCanada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 February 03].
  • Next link will take you to another Web site Canadian Nutrient File. Food Directorate, Health Canada; 2009. [Accessed 2012 February 03].
  • Evans WC. Trease and Evans Pharmacognosy, 16th edition. Toronto (ON): Saunders Elsevier; 2009.
  • Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Grover JK, Yadav S, Vats V. Medicinal plants of India with anti-diabetic potential. Journal of Ethnopharmacology 2002;82(1):81-100.
  • Next link will take you to another Web site Holy Basil (Ocimum sanctum L.) Natural Standard Professional Monograph [Internet]. Natural Standard Inc; 2012 [Accessed 2012 February 06].
  • Kapoor S. Ocimum sanctum: A therapeutic role in diabetes and the metabolic syndrome. Hormone and Metabolic Research 2008;40:296
  • Liu JP, Zhang M, Wang M, Grimsgaard S. Chinese herbal medicines for type 2 diabetes mellitus (Review). Cochrane Database of Systemic Reviews 2002, Issue 3. Art. No.: CD003642. DOI: 10.1002/14651858.CD003642.pub2.
  • McGuffin, M., Hobbs, C., Upton, R., Goldberg, A. American Herbal Products Association's Botanical Safety Handbook. Boca Raton, Florida: CRC Press LLC. 1997.
  • Miller R, Miller S. Tulsi Queen of Herbs: India's Holy Basil. The Green Isle Enterprise: Salt Spring Island (BC); 2003.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Mondal S, Mirdha BR, Mahapatra SC. The science behind sacredness of Tulsi (Ocimum sanctum Linn). Indian Journal of Physiology and Pharmacology 2009;53(4):291-306.
  • Mondal S, Varma S, Bamola VD, Naik SN, Mirdha BR, Padhi MM, Mehta N, Mahapatra SC. Double-blinded randomized controlled trial for immunomodulatory effects of Tulsi (Ocimum sanctum Linn.) leaf extract on healthy volunteers. Journal of Ethnopharmacology 2011; 136 (3): 452-456.
  • Rosenbaum CC, O'Mathúna DP, Chavez M, Shields K. Antioxidants and anti-inflammatory dietary supplements for osteoarthritis and rheumatoids arthritis. Alternative Therapies in Health and Medicine 2010;16(2):32-40.
  • Shekelle PG, Hardy M, Morton SC, Coulter I, Venuturupalli S, Favreau J, Hilton LK. Are Ayurvedic herbs for diabetes effective? The Journal of Family Practice 2005;54(10):876-886.
  • Singh N. A new concept on the possible therapy of stress diseases with "adaptogen" (anti-stress drugs) of indigenous plant origin. Current Medical Practice 1981:25:1-50.
  • Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives. Next link will take you to another Web site Eugenyl Methyl Ether. [Internet]. [Updated 12 November 2001; Accessed 2012 February 7].
  • Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives. Next link will take you to another Web site Beta-Caryophyllene. [Internet]. [Updated 28 January 2006; Accessed 2012 February 7].
  • Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives. Next link will take you to another Web site Eugenol. [Internet]. [Updated 31 January 2006; Accessed 2012 February 7].
  • Ulbricht C, Basch E, Weissner W, Hackman D. An evidence-based systematic review of herbs and supplement interactions by the Natural Standard Research Collaboration. Expert Opinion on Drug Safety 2006;5(5):719-728.
  • Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. Systematic review of herbs and dietary supplements for glycemic control in diabetes. Diabetes Care 2003;26(4):1277-1294.
  • Zamin M. Ocimum sanctum may overcome fatigue stress. Pakistan Journal of Biological Sciences. 2011: 14 (21), 1000-1001.