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Drugs and Health Products


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 applicantâ??s discretion.
  • The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 31, 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)
Ginkgo biloba
  • Ginkgo
  • Ginkgo biloba
  • Maidenhair tree
  • Baiguo
  • Icho
Ginkgo biloba Leaf

References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000, WHO 1999, Source material: Birks and Evans 2007.

Route(s) 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 category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

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

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 (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 day

Consult 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 day

Consult 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 day

Consult 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

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 specifications outlined in the NHPID.

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.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association. 
  • Mehlsen J, Drabaek H, Wiinberg N, Winther K. 2002. Effects of a Ginkgo biloba extract on forearm haemodynamics in healthy volunteers. Clinical Physiology and Functional Imaging 22(6):375-378. Mix JA, Crews WD. 2002. A double-blind, placebo-controlled, randomized trial of Ginkgo biloba extract EGb 761 in a sample of cognitively intact older adults: neuropsychological findings. Human Psychopharmacology: Clinical and Experimental 17(6):267-277.
  • 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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  • Huang SY, Jeng C, Kao SC, Yu JJ, Liu DZ. 2004. Improved haemorrheological properties by Ginkgo biloba extract (Egb 761) in type 2 diabetes mellitus complicated with retinopathy. Clinical Nutrition 23(4):615-621.
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