Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Monograph: Tribulus - Tribulus terrestris

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.



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 "Traditional Chinese Medicine", "Ayurveda", or "Ayurvedic medicine".

Date: 2013-01-22

NHPID Name

Tribulus terrestris (USDA 2008)

Proper Name(s)

Tribulus terrestris L. (1753) (Zygophyllaceae) ( USDA 2011 , PPRC 2010 , API 2001 , McGuffin et al. 2000 )

Common Name(s)

Source Material


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:

  • Traditionally used in Ayurveda as Mutrala (diuretic)  (Premila 2006, API 2001, Kapoor 2001)
  • Traditionally used in Ayurveda as Vrsya (aphrodisiac) for men  (Paranjpe 2005, API 2001)
  • Traditionally used in Ayurveda for relief of Mutrakrcchra (difficult/painful urination)  (Khare 2004, API 2001)
  • Traditionally used in Ayurveda to help relieve Arsa (haemorrhoids)  (API 2001)
  • Used in Traditional Chinese Medicine (TCM) for headache and dizziness, distending pain in the chest and the hypochondrium, acute mastitis, red eyes and nebula, itching caused by rubella  (PPRC 2010)
  • Used in Traditional Chinese Medicine (TCM) to calm the Liver and anchor the yang: for headache, vertigo, or dizziness from ascendant Liver yang  (Bensky et al. 2004)
  • Used in Traditional Chinese Medicine (TCM) to dispel wind and stop itching: for any kind of skin lesion with significant itching, such as hives  (Bensky et al. 2004)
  • Used in Traditional Chinese Medicine (TCM) to dispel wind-heat and brightens the eyes: for red, swollen, and painful eyes as well as increased tearing  (Bensky et al. 2004)
  • Used in Traditional Chinese Medicine (TCM) to dredge the Liver qi to smooth its flow while dispersing constraint and clumping: for pain and distention in the chest or flanks, irregular menstruation, or insufficient lactation, from constrained Liver qi  (Bensky et al. 2004)
  • Used in Traditional Chinese Medicine (TCM) to pacify the Liver, active blood and dispel wind, improve vision, and relieve itching  (PPRC 2010)

Dose(s)

Adults:

Arsa (haemorrhoids)
Preparation: Decoction

Dose(s): Fruit: 20 - 30 Grams per day, dried fruit
Preparation: Powdered

Dose(s): Fruit: 3 - 6 Grams per day, dried fruit
Mutrala (diuretic); Vrsya (aphrodisiac); Mutrakrcchra (difficult/painful urination)
Preparation: Decoction

Dose(s): Fruit: 20 - 30 Grams per day, dried fruit
Dose(s): Root: 20 - 30 Grams per day, dried root
Preparation: Powdered

Dose(s): Fruit: 3 - 6 Grams per day, dried fruit
TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver
Preparation: Decoction

Dose(s): Fruit: 6 - 10 Grams per day, dried fruit

Duration of use

Mutrala (diuretic): For occasional use only  (APhA 2002, CPhA 2002)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Mutrala (diuretic); Mutrakrcchra (difficult/painful urination); Arsa (haemorrhoids); TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    If symptoms persist or worsen, consult a health care practitioner.
  • Mutrala (diuretic); Mutrakrcchra (difficult/painful urination); Arsa (haemorrhoids); TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    If you are pregnant, consult a health care practitioner prior to use  (Chen and Chen 2004)
  • TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    In case of qi or blood deficiency, consult a health care practitioner prior to use  (Bensky et al. 2004)

Contraindication(s):
  • TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    If you have a liver deficiency, do not use this product  (Bensky et al. 2004)
  • TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    If you have hypotension, do not use this product  (Chen and Chen 2004)

Known Adverse Reaction(s):
  • Hypersensitivity/allergy has been known to occur; in which case, discontinue use.  (Bensky et al. 2004)
  • Vrsya (aphrodisiac); Mutrakrcchra (difficult/painful urination); Arsa (haemorrhoids); TCM rubella symptoms; TCM to calm liver and anchor yang; TCM to dispel wind; TCM to dispel wind-heat; TCM to dredge liver qi; TCM to pacify liver:
    Diuretic effect may occur.

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

  • APhA 2002: Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • API 2001: The Ayurvedic Pharmacopoeia of India. 1st edition, Part I, Volume I. Delhi (IN): The Controller of Publications; 2001 [Reprint of 1990 publication].
  • Bensky D, Clavey S, Toger E, Gamble A, editors. Chinese Herbal Medicine Materia Medica. 3rd edition. Seattle (WA): Eastland Press Inc; 2004.
  • Chen JK, Chen TT. Chinese Medical Herbology and Pharmacology. Crampton L, editor. City of Industry (CA): Art of Medicine Press Inc.; 2004.
  • CPhA 2002: Patient Self-Care: Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Kapoor LD. Handbook of Ayurvedic Medicinal Plants. Boca Raton (FL): CRC Press; 2000.
  • Khare CP. Indian Herbal Remedies: Rational Western Therapy, Ayurvedic and Other Traditional Usage, Botany. New York (NY): Springer; 2004.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Neychev VK, Mitev VI. The aphrodisiac herb Tribulus terrestris does not influence the androgen production in young men. Journal of Ethnopharmacology 2005;101(1-3):319-323.
  • Paranjpe P. Indian Medicinal Plants: Forgotten Healers, A Guide to Ayurvedic Herbal Medicine. Delhi (IN): Chaukhamba Sanskrit Pratishthan; 2005 [Reprint of 2001].
  • PPRC 2010: Pharmacopoeia of the People's Republic of China. English Version. Volume I. Beijing (CN): Chinese Pharmacopoeia Commission; 2010.
  • Premila MS. Ayurvedic Herbs: A Clinical Guide to the Healing Plants of Traditional Indian Medicine. New York (NY): Haworth Press Inc.; 2006.
  • USDA 2011: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Beltsville (MD): National Germplasm Resources Laboratory. [Tribulus terrestris L. Last updated 2011 May 09; Accessed 2012 April 30]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References reviewed

  • Adimoelja A, Adaikan PG. Protodioscin from herbal plant Tribulus terrestris L improves the male sexual functions, probably via DHEA [Internet]. Airlangga University, Indonesia and National University of Singapore in 6th Biennial Asian-Pacific Meeting on Impotence in Kuala Lumpur, Malaysia, International Journal of Impotence Research 1997;9(S1). [Accessed 2012 April 30]. Available from: http://www.libilov.com/en/clinical_studies/study_Adimoelja_Adaikan_1997.htm
  • Adimoelja A, Setiawan L, Djojotananjo T. Tribulus terrestris (protodioscin) in the treatment of male infertility with idiopathic ologiasthenoteratozoospermia 1995 [Internet]. Academic Hospital Dr. Soetomo and Airlangga University, Surabaya, Indonesia in First International Conference of Medical Plants for Reproductive Medicine in Taipei, Taiwan. [Consulté le 30 avril 2012]. Disponible ŕ : http://www.libilov.com/en/clinical_studies/study_Adimoelja_1995.htm
  • Antonio J, Uelmen J, Rodriguez R, Earnest C. The effects of Tribulus terrestris on body composition and exercise performance in resistance-trained males. International Journal of Sport Nutrition and Exercise Metabolism 2000;10(2):208-215.
  • Arsyad KM. Effect of protodioscin (Tribulus terrestris) on the well-being and sexual response of men with diabetes mellitus. 1997 [Internet]. Medical Biology Division of Andrology, University of Sriwijaya, Indonesia. [Accessed 2012 April 19]. Available from: http://www.libilov.com/en/clinical_studies/study_Arsyad_1997.htm
  • Arsyad KM. Effect of protodioscin on the quantity and quality of sperms from males with moderate idiopathic oligozoospermia. Medika 1996;22(8):614-618.
  • Brinker 2010: Brinker F. 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 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts With Medicines, expanded 4th Edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • Brown GA, Vukovich MD, Martini ER, Kohut ML, Franke WD, Jackson DA, King DS. Effects of androstenedione-herbal supplementation on serum sex hormone concentrations in 30- to 59-year-old men. International Journal for Vitamin and Nutrition Research 2001b;71(5):293-301.
  • Brown GA, Vukovich MD, Martini ER, Kohut ML, Franke WD, Jackson DA, King DS. Endocrine and lipid responses to chronic androstenediol-herbal supplementation in 30 to 58 year old men. Journal of American College of Nutrition 2001a;20(5):520-528.
  • Chandler F, editor. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association; 2000.
  • Dinchev D, Janda B, Evstatieva L, Oleszek W, Aslani MR, Kostova I. Distribution of steroidal saponins in Tribulus terrestris from different geographical regions. Phytochemistry 2008;69(1):176-186.
  • Ganzera M, Bedir E, Khan IA. Determination of steroidal saponins in Tribulus terrestris by reversed-phase high-performance liquid chromatography and evaporative light scattering detection. Journal of Pharmaceutical Sciences 2001;90(11):1752-1758.
  • Gauthaman K, Adaikan PG, Prasad RN. Aphrodisiac properties of Tribulus Terrestris extract (Protodioscin) in normal and castrated rats. Life Sciences 2002;71(12):1385-1396.
  • Gauthaman K, Ganesan AP. The hormonal effects of Tribulus terrestris and its role in the management of male erectile dysfunction - an evaluation using primates, rabbit and rat. Phytomedicine 2008;15(1-2):44-54.
  • Jain SK, DeFilipps RA. Medicinal Plants of India. Michigan: Reference Publishers Inc; 1991.
  • Jameel JK, Kneeshaw PJ, Rao VS, Drew PJ. Gynaecomastia and the plant product "Tribulis terrestris". Breast 2004;13(5): 428-430.
  • Kohut ML, Thompson JR, Campbell J, Brown GA, Vukovich MD, Jackson DA, King DS. Ingestion of a dietary supplement containing dehydroepiandosterone (DHEA) and androstenedione has minimal effect on immune function in middle-aged men. Journal of American College of Nutrition 2003;22(5):363-371.
  • Kostova I, Dinchev D. Sappnins in Tribulus terrestris - chemistry and bioactivity. Phytochemistry Reviews 2005;4(2-3):111-137.
  • Milanov S, Maleeva E, Taskov M. Tribestan effect on the concentration of some hormones in the serum of healthy volunteers. Medico biologic information 1985;4:27-29.
  • Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Natural Standard. Tribulus terrestris (tribulus). Copyright 2012 [Internet]. [Accessed 2012 April 18]. Available from: http://www.naturalstandard.com.
  • Obreshkova D, Pangarova T, Milkov S, Dinchev D. Comparative analytical investigation of Tribulus terrestris preparations. Pharmacia 1998;15(2):11.
  • Poprzecki S, Zebrowska A, Cholewa J. Ergogenic effects of Tribulus terrestris supplementation in men. Journal of Human Kinetics 2005;13:41-50.
  • Premila MS. Ayurvedic Herbs: A Clinical Guide to the Healing Plants of Traditional Indian Medicine. Binghamton (NY): The Haworth Press inc: 2006.
  • Rogerson S, Riches CJ, Jennings C, Weatherby RP, Meir RA, Marshall-Gradisnik SM. The effect of five weeks of Tribulus terrestris supplementation on muscle strength and body composition during preseason training in elite rugby league players. Journal of Strength and Conditioning Research 2007;21(2):348-353.
  • Sengupta G, Hazra A, Kundu A, Ghosh A. Comparison of Murraya koenigii and Tribulus terrestris-based formulation versus tamsulosin in the treatment of benign prostatic hyperplasia inTribulus - Tribulus terrestris Page 8 of 8men aged > 50 years: a double-blind, double-dummy, randomized controlled trial. Clinical Therapeutics 2011;33(12):1943-1952.
  • Setiawan L. Tribulus terrestris L. extract improves spermatozoa motility and increases the efficiency of acrosome reaction in subjects diagnosed with oligoastheno-teratozoospermia. Journal of Panca Sarjana. University of Airlangga 1996;5(2-3):35-40.
  • Talasaz AH, Abbasi MR, Abkhiz S, Dashti-Khavidaki S. Tribulus terrestris-induced severe nephrotoxicity in a young healthy male. Nephrology, Dialysis, Transplantation 2010;25(11):3792-3973.
  • Talbott SM, Hughes K. The Health Professional's Guide to Dietary Supplements. Baltimore (MD): Lippincott Williams & Wilkins; 2007.
  • Williamson EM, editor. Major Herbs of Ayurveda. New York (NY): Churchill Livingstone; 2002.