GINKGO - GINKGO BILOBA
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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 applicants discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
January 27, 2023
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | |
---|---|---|---|
Source material(s) | Part(s) | ||
Ginkgo biloba |
|
Ginkgo biloba | Leaf |
References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000, WHO 1999, Source information: Birks and Evans 2007.
Route(s) of administration
OralDosage form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
Use(s) or Purpose(s)
- Helps to enhance cognitive function in adults (Cieza et al. 2003; Santos et al. 2003; Mix and Crews 2002; Stough et al. 2001; Kennedy et al. 2000; Mix and Crews 2000).
- Helps to enhance memory in adults (Santos et al. 2003; Stough et al. 2001; Kennedy et al. 2000; Mix and Crews 2000).
- Helps to support peripheral circulation (Boelsma et al. 2004; Mehlsen et al. 2002; Pittler and Ernst 2000).
The following combined use(s) or purpose(s) is/are also acceptable:
- Helps to enhance cognitive function and memory in adults (Cieza et al. 2003; Santos et al. 2003; Mix and Crews 2002; Stough et al. 2001; Kennedy et al. 2000; Mix and Crews 2000).
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Methods of Preparation: Standardized Extracts (Dry extract)
80 - 240 milligrams of extract, per day (50:1; quantity crude equivalent 4 - 12 grams of dried leaves), standardized to 22-27% flavonoid glycosides and 5-7% terpene lactones; and providing at least 80 milligrams of extract per single dose (Crew et al. 2005; Cieza et al. 2003; Santos et al. 2003; Mix and Crews 2002; Blumenthal et al. 2000; Kennedy et al. 2000; Pittler and Ernst 2000; WHO 1999).
Direction(s) for use
No statement required.
Duration of use
Products providing 80 mg to less than 120 mg of extract (4 g to less than 6 g dried leaves), per dayConsult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 8 months (Santos et al. 2003; Le Bars et al. 1997; Grassel 1992).
Products providing 120 mg to 180 mg of extract (6 g to 9 g dried leaves), per dayConsult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 weeks (Elsabagh et al. 2005; Mix and Crews 2002; Mix and Crews 2000).
Products providing more than 180 mg to 240 mg of extract (more than 9 g to 12 g dried leaves), per dayConsult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks (Cieza et al. 2003).
Risk information
Caution(s) and warning(s)
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (Blumenthal et al. 2000; WHO 1999).
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking medications for diabetes, high blood pressure or seizures (Brinker 2018)
Contraindication(s)
Do not use this product if you are taking health products that affect blood coagulation as this may increase the risk of spontaneous bleeding (Brinker 2018; Bent 2005).
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
Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).
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 specifications outlined in the NHPID.
- Ginkgolic acids: Testing must be performed to ensure that the finished product meets the toxicity restrictions for Ginkgolic acids of not more than 5 ppm [USP 43-NF38; Ph.eur. 11th edition 2022 (11.1); Boateng and Yang 2022; Boateng 2022].
References cited
- Bent S, Goldberg H, Padula A, Avins AL. 2005. Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature. Journal of General Internal Medicine 20(7):657-661.
- Birks J, Grimley Evans J. 2007. Ginkgo biloba for cognitive impairment and dementia(Review). Oxfordshire (UK): The Cochrane Database of Systematic Reviews; Issue 2. Art. No.: CD003120. DOI: 10.1002/14651858.CD003120.pub2
- Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications.
- Boelsma E, Lamers RJ, Hendriks HF, Van Nesselrooij JH, Roza L. 2004. Evidence of the regulatory effect of Ginkgo biloba extract on skin blood flow and study of its effects on urinary metabolites in healthy humans. Planta Medica 70(11):1052-1057.
- Brinker F.2018. Online Updates and Additions to Herb Contraindications and Drug Interactions, 4thedition. Sandy (OR): Eclectic Medical Publications. [Accessed 2018 June 1]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions/
- Cieza A, Maier P, Pöppel E. 2003. Effects of Ginkgo biloba on mental functioning in healthy volunteers. Archives of Medical Research 34(5):373-381.
- Crews WD, Harrison DW, Griffin ML, Falwell KD, Crist T, Longest L, Hehemann L, Rey ST. 2005. The neuropsychological efficacy of Ginkgo preparations in healthy and cognitively intact adults: a comprehensive review. HerbalGram: The Journal of the American Botanical Council 67:43-62.
- Elsabagh S, Hartley DE, Ali O, Williamson EM, File SE. 2005. Differential cognitive effects of Ginkgo biloba after acute and chronic treatment in healthy young volunteers. Psychopharmacology 179(2):437-446.
- Grässel E. 1992. [Effect of Ginkgo-biloba extract on mental performance. Double-blind study using computerized measurement conditions in patients with cerebral insufficiency]. Fortschritte der Medizin 110(5):73-76 (in German).
- Kennedy DO, Scholey AB, Wesnes KA. 2000. The dose-dependent cognitive effects of acute administration of Ginkgo biloba to healthy young volunteers. Psychopharmacology 151(4):416423.
- Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. 1997. A placebocontrolled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. North American EGb Study Group. The Journal of the American Medical Association 278(16):13271332.
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- Mix JA, Crews WD. 2000. An examination of the efficacy of Ginkgo biloba extract EGb761 on the neuropsychologic functioning of cognitively intact older adults. Journal of Alternative and Complementary Medicine 6(3):219-229.
- Pittler MH, Ernst E. 2000. Ginkgo biloba extract for the treatment of intermittent claudication: a meta-analysis of randomized trials. The American Journal of Medicine 108(4):276-281.
- Santos RF, Galduróz JC, Barbieri A, Castiglioni ML, Ytaya LY, Bueno OF. 2003. Cognitive performance, SPECT, and blood viscosity in elderly non-demented people using Ginkgo biloba. Pharmacopsychiatry 36(4):127-133.
- Stough C, Clarke J, Lloyd J, Nathan PJ. 2001. Neuropsychological changes after 30-day Ginkgo biloba administration in healthy participants. The International Journal of Neuropsychopharmacology 4(2):131-134.
- USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). 2001. Ginkgo biloba L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 June 1]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/taxon.pl?17540
- WHO 1999: World Health Organization. WHO monographs on selected medicinal plants, Volume 1. Geneva (CHE): World Health Organization.
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