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Monograph: Holy Basil - Ocimum Tenuliflorun - 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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for traditional use must include the term "Ayurvedic Medicine/Ayurveda".

Date: 2013-03-22

NHPID Name

Ocimum tenuiflorum (USDA 2008)

Proper Name(s)

Common Name(s)

Source Material

Seed ( API 1999 )

Route 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:

General
  • 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)


Dose(s)

Adults:

Preparation: Powdered

Dose(s): 1 - 2 Grams per day, powdered dry seed

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
  • If you have a cardiovascular condition, or are taking any heart or blood pressure medication, consult a health care practitioner prior to use  (Rai et al. 1997, Agrawal et al. 1996)
  • Relief of cough; digestion:
    If symptoms persist or worsen, consult a health care practitioner.

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database 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 NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (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. Int J Clin Pharmacol Ther 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.
  • 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. 2nd 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 2007: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Ocimum tenuiflorum L. Last updated 2007 October 29; Accessed 2012 April 26]. Available from: http://www.ars-grin.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. J Basic Clin Physiol Pharmacol 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 Med Coll J 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. 2010. 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 April 18]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • 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/start-debuter.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.
  • Grover JK, Yadav S, Vats V. Medicinal plants of India with anti-diabetic potential. J Ethnopharmacol 2002; 82(1): 81-100.
  • 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. Horm Metab Res 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.
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  • Mondal S, Mirdha BR, Mahapatra SC. The science behind sacredness of Tulsi (Ocimum sanctum Linn). Indian J Physiol Pharmacol 2009; 53(4): 291-306.
  • Murthy KRS. Bhavaprakasa of Bhavamisra. Volume 1. Varanasi (IN): Chowkhamba Krishnadas Academy; 2004.
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  • Rosenbaum CC, O'Mathúna DP, Chavez M, Shields K. Antioxidants and anti-inflammatory dietary supplements for osteoarthritis and rheumatoids arthritis. Altern Ther Health Med 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.
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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 Opin Drug Saf 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.
  • WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.
  • 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.
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