THYME - THYMUS VULGARIS - Oral
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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
July 1, 2019
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Thymus vulgaris |
|
Thymus vulgaris |
|
Dried |
References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersma and Léon 1999; Source materials: Hoffmann 2003, Blumenthal et al. 2000, WHO 1999.
Route of Administration
Oral (Mills and Bone 2005; Blumenthal et al. 2000)
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms by age group:
Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006).
Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- Traditionally used in Herbal Medicine as an expectorant to help relieve the symptoms of bronchitis and mucus buildup of the (upper) respiratory tract (anti-catarrh) (EMA 2014; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003).
- Traditionally used in Herbal Medicine to help relieve coughs (spasmolytic) (EMA 2014; Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000).
- Traditionally used in Herbal Medicine to help relieve indigestion/flatulent dyspepsia and colic (carminative) (Bradley 2006; Mills and Bone 2005; Hoffmann 2003).
The following combined use(s) or purpose(s) is/are also acceptable:
Traditionally used in Herbal Medicine to help relieve coughs (spasmolytic), the symptoms of bronchitis and mucus buildup of the (upper) respiratory tract (anti-catarrh) (EMA 2014; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Children 1 to 11 years, Adolescents 12 to 17 years and Adults 18 years and older (EMA 2014; ESCOP 2003)
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
1 - 8.4 grams of dried leaf and/or flowering herb top, per day (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000)
Direction(s) for use
No statement required.
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
- Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant.
Contraindication(s)
No statement required.
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
- 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.
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- Bove, M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated; 2001.
- Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
- EMA 2014. European Medicines Agency. Community Monograph on Thymus vulgaris L. and Thymus zygis L., Herba. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), February 06 2014. [Accessed 2019 May 23]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-herba_en.pdf
- EMA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. Adopted September 2006. EMA/CHMP/PEG/194810/2005. [Accessed on 2019 May 23]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
- Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN).
- Thymus vulgaris L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 23]. Available from:
- https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CHE): World Health Organization; 1999.
- Wiersema J, Léon B. World Economic Plants: A Standard Reference. Boco Raton (FL): CRC Press LLC; 1999.
References Reviewed
- Basch E, Ulbricht C, Hammerness P, Bevins A, Sollars D. Thyme (Thymus vulgaris L.), thymol. Journal of Herbal Pharmacotherapy 2004;4(1):49-67.
- Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
- Brinker F. The Toxicity of Botanical Medicines. Sandy (OR): Eclectic Medical Publications; 2000.
- BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
- Gruenwald J, Graubaum HJ, Busch R. Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial. Arzneimittel-Forschung 2006;56(8):574-581.
- Gruenwald J, Graubaum HJ, Busch R. Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. A double-blind, randomized, placebo- controlled clinical trial. Arzneimittel-Forschung 2005;55(11):669-676.
- Kemmerich B, Eberhardt R, Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittel- Forschung 2006;56(9):652-660.
- McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
- Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
- Schilcher, H. Phytotherapy in Paediatrics. Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.