HOLY BASIL - OCIMUM TENUIFLORUM - SEED

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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

December 18, 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
Ocimum tenuiflorum	Holy basil Rama tulsi Sacred basil Tulsi	Ocimum tenuiflorum	Seed	Dried

References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, API 1999; Source material: API 1999.

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 demulcent) to help relieve cough (Kasa) (Mishra 2004; Kapoor 2001; API 1999).
• Traditionally used in Ayurveda as a cardiotonic (Hrdya) (API 1999).
• Traditionally used in Ayurveda to aid digestion (Dipani) (API 1999).

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

Traditionally used in Ayurveda (as a demulcent) to help relieve cough (Kasa), as a cardiotonic (Hrdya) and to aid digestion (Dipani) (Mishra 2004; Kapoor 2001; API 1999).

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)

1 - 2 grams of dried seed, per day (Williamson 2002; Kapoor 2001; API 1999).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All products

• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant, breastfeeding or have a cardiovascular condition (Rai et al. 1997; Agrawal et al. 1996).
• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking any heart or blood pressure medication (Rai et al. 1997; Agrawal et al. 1996).

Relief of cough; Digestive aid

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

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement 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.

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

• 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.
• API 1999: The Ayurvedic Pharmacopoeia of India. 1st edition, Part I, Volume I. Delhi (IN): The Controller of Publications; 1999.
• ITIS 2018: Integrated Taxonomic Information System [Internet]. [Accessed 2018 September 28]. Available from: http://www.itis.gov
• Kapoor LD. Handbook of Ayurvedic Medicinal Plants. Baton Roca (FL): CRC Press LLC; 2001.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2^nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
• Mishra LC, editor. Scientific Basis for Ayurvedia Therapies. Baton Roca (FL): CRC Press LLC; 2004.
• 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 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). [Accessed 2018 September 28]. Available from: http://www.arsgrin.gov/cgi-bin/npgs/html/tax_search.pl
• Williamson EM, editor. Major Herbs of Ayurveda. Edinburgh (GB): Churchill Livingstone; 2002

References Reviewed

• 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.
• 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): 176179.
• 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. Final updates and additions for Herb Contraindications and Drug Interactions, 3^rd 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 April 18]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
• Brinker F. The Toxicology of Botanical Medicines. Sandy, Oregon: Eclectic Medical Publications; 2000.
• Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2012. [Date modified: 2012 May 04; Accessed 2012 July 11]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
• Canadian Nutrient File. Food Directorate, Health Canada; 2012. [Date modified: 2012 April 26; Accessed 2012 July 11]. Available from http://webprod3.hc-sc.gc.ca/cnf-fce/startdebuter.do?lang=eng
• Dr. Duke's Phytochemical and Ethnobotanical Databases. [Accessed 2013 February 19]. Available from http://www.ars-grin.gov/duke/
• Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
• Gogte VVM. Ayurvedic Pharmacology and Therapeutic Uses of Medicinal Plants. Mubai (IN): Bharatiya Vidya Bhavan; 2000.
• Holy Basil (Ocimum sanctum L.) Natural Standard Professional Monograph [Internet]. Natural Standard Inc; 2012 [Accessed 2012 April 18]. Available from http://naturalstandard.com/databases/herbssupplements/holybasil.asp
• Jain SK. DeFillips RA. Medicinal Plants of India. Volume 1. Algonac (MI): Reference Publications, Inc; 1991.
• Kapoor S. Ocimum sanctum: A therapeutic role in diabetes and the metabolic syndrome. Hormone and Metabolic Research 2008; 40: 296.
• Khory RN, Katrak NN. Materia Medica of India and their Therapeutics. Delhi (IN): Komal Prakashan; 1999 [Reprint of 1903 publication].
• 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.
• 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.
• 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.
• Sudarshan SR. Encyclopaedia of Indian Medicine, Materia Medica - Herbal Drugs. Volume 4. Banglore (IN): Popular Prakashan; 2005.
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• 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.
• Warrier PK, Nambiar VPK, Ramankutty C, editors. Indian Medicinal Plants: a compendium of 500 species. Volume 4. Chennai (IN): Orient Longman Private Limited; 2003.
• Winston D, Maimes S. Adaptogens: Herbs for strength, stamina and stress relief. Healing Arts Press; Rochester (VT); 2007.
• WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.
• Wohlmuth H. Sacred basil - an Ayurvedic adaptogen. Botanical Pathways, 2002; Issue 11.
• 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.