GENTIAN - GENTIANA LUTEA

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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)

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
Gentiana lutea	Bitterwort Gentian Gentian-root Yellow gentian	Gentiana lutea	Root	Dried

References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersema and León 1999; Source material: Blumenthal et al. 2000.

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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Traditionally used in Herbal Medicine to help relieve digestive disturbances (such as dyspepsia) (Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992;Williamson et al. 1988; Felter and Lloyd 1983; Grieve 1971).
• Traditionally used in Herbal Medicine as a digestive tonic and bitter to help stimulate appetite and aid digestion (stomachic) (Mills and Bone 2005; Wichtl 2004; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992; Williamson et al.1988; Felter and Lloyd 1983; Grieve 1971).
• Traditionally used in Herbal Medicine to help prevent nausea (anti-emetic) (Bradley 1992; Williamson et al. 1988).
• Used in Herbal Medicine to help increase bile flow (cholagogue) (Wichtl 2004; Hoffmann 2003; Blumenthal et al. 2000).

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

Traditionally used in Herbal Medicine as a digestive tonic and bitter to help stimulate appetite, aid digestion and help relieve digestive disturbances (Mills and Bone 2005; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992; Williamson et al. 1988; Felter and Lloyd 1983; Grieve 1971).

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-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.1 - 6 grams of dried root, per day (Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al.2000; Bradley 1992)

Direction(s) for use (optional)

Take 15 - 60 minutes before meals (ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Bradley 1992).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

• Consult a health care 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 breastfeeding.

Contraindication(s)

Do not use this product if you are pregnant or have acute stomach irritation, inflammation and stomach or duodenal ulcers (ESCOP 2003; Hoffmann 2003; Brinker 2001; Bradley 1992; Morimoto et al.1983).

Known adverse reaction(s)

Some people may experience headaches (ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).

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

• Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
• Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association; 1992.
• Brinker F. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
• Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
• Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
• Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2^nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
• Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
• Morimoto I, Nozaka T, Watanabe F, Ishino M, Hirose Y, Okitsu T. Mutagenic activities of gentisin and isogentisin from Gentianae radix (Gentianaceae). Mutation Research 1983;116(2):103-117.
• USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Gentiana lutea L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 17]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
• Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3^rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
• Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
• Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.

References Reviewed

• Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3^rd edition. London (UK): The Pharmaceutical Press; 2007.
• BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.