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 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	Leaf	Dried

References: Proper name: USDA 2018; McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, API 1999; Source material: API 1999, Agrawal et al. 1996.

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 for the specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• 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 mucus buildup (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; Hoffmann 2003; Williamson 2003).
• Source of/Provides antioxidants (Hakkim et al. 2007; Winston and Maimes 2007; Williamson 2003).

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

Traditionally used in Ayurveda (as an expectorant and/or demulcent) to help relieve cough (Kasa) and colds and respiratory mucus buildup (catarrh) (Premila 2006; Paranjpe 2005; Sudarshan 2005; Mishra 2004; Williamson 2002; Kapoor 2001; Gogte 2000; API 1999; Jain 1991).

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)

Antioxidant

Not to exceed 3 grams of dried leaf, per day (API 1999).

Ayurveda; Adaptogen

2 - 3 grams of dried leaf, per day (API 1999).

Methods of preparation: Non-Standardised Aqueous Extracts (Dry extract, Decoction, Infusion)

Antioxidant

Not to exceed 28 grams of dried leaf, per day (Williamson 2002; Kapoor 2001).

Ayurveda

7 - 28 grams of dried leaf, per day (Williamson 2002; Kapoor 2001).

Adaptogen

4.2 - 28 grams of dried leaf, per day (Winston and Maimes 2007; Williamson 2002; Kapoor 2001).

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 breastfeeding, have a heart condition or diabetes (WHO 2002; 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/cold/respiratory mucus buildup; Digestive aid; Adaptogen

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

Contraindication(s)

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

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.
• 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 2018: Integrated Taxonomic Information System [Internet]. [Accessed 2018 September 27]. 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 2018: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 September 27]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=25491
• 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. 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.
• Williamson EM, editor. Major Herbs of Ayurveda. Edinburgh (GB): Churchill Livingstone; 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.

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):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. 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• 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 February 01]. 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; 2011. [Accessed 2012 February 03]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
• Canadian Nutrient File. Food Directorate, Health Canada; 2009. [Accessed 2012 February 03]. 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/
• 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.
• Holy Basil (Ocimum sanctum L.) Natural Standard Professional Monograph [Internet]. Natural Standard Inc; 2012 [Accessed 2012 February 06]. Available from http://naturalstandard.com/databases/herbssupplements/holybasil.asp
• 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.
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• 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.
• 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.
• 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. Eugenol. [Internet]. [Updated 31 January 2006; Accessed 2012 February 7]. Available from http://www.inchem.org/documents/jecfa/jeceval/jec_841.htm
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• 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.