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Mono Ginger English

This monograph provides guidelines for the preparation of Product Licence Applications for the natural health product Ginger (Zingiber officinale), detailing its uses, dosage forms, and administration routes. Ginger is traditionally used to prevent nausea and vomiting, relieve digestive upset, and act as an expectorant. The document outlines dosage recommendations and cautions for various age groups, as well as preparation methods and storage conditions.

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0% found this document useful (0 votes)
9 views5 pages

Mono Ginger English

This monograph provides guidelines for the preparation of Product Licence Applications for the natural health product Ginger (Zingiber officinale), detailing its uses, dosage forms, and administration routes. Ginger is traditionally used to prevent nausea and vomiting, relieve digestive upset, and act as an expectorant. The document outlines dosage recommendations and cautions for various age groups, as well as preparation methods and storage conditions.

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beben main acc
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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NATURAL HEALTH PRODUCT

GINGER – ZINGIBER OFFICINALE

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 May 20, 2022

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information


Source information
Proper name(s) Common name(s)
Source material(s) Part(s) Preparation(s)
Zingiber officinale Ginger Zingiber officinale Rhizome Dry
Jiang
References: Proper name: USDA 2018; Common names: McGuffin et al. 2000, Wiersema and León 1999;
Source information: McGuffin et al. 2000, WHO 1999, Bradley 1992.

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 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)

Help(s) prevent nausea and vomiting associated with motion sickness, and/or seasickness
(Lien et al. 2003; Riebenfeld and Borzone 1999; Schmid et al. 1994; Grøntved et al. 1988;
Mowrey and Clayson 1982).
Traditionally used in Herbal Medicine to help relieve digestive upset including lack of
appetite, nausea, digestive spasms, indigestion, dyspepsia, and flatulent colic (carminative)
(Mills and Bone 2000; Bradley 1992; Ellingwood 1983; Felter and Lloyd 1983).
Traditionally used in Herbal Medicine as an expectorant and cough suppressant (antitussive)
to help relieve bronchitis as well as coughs and colds (Mills and Bone 2000; Bradley 1992;
Ellingwood 1983 ; Wren 1907).

Note
Claims for traditional use must include the term “Herbal Medicine”, “Traditional Chinese
Medicine”, or “Ayurveda”.

Dose(s)

Subpopulation(s)

Children 6-11 years, Adolescents 12-17 years and Adults 18 years and older (ESCOP 2003)

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract,


Tincture, Fluid extract).

Motion sickness/seasickness (nausea and vomiting prevention)

0.5-3 grams of dried rhizome, per day (Mills and Bone 2005; ESCOP 2003; Bradley 1992).

Other uses

0.3-3 grams of dried rhizome, per day (Mills and Bone 2005; Bradley 1992; Felter and Lloyd
1898; Wren 1907).

Methods of preparation: Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)

All uses

0.7-3 grams of dried rhizome, per day (Mills and Bone 2005).

Ginger - Zingiber officinale Page 2 of 5


Direction(s) for use

Motion sickness/seasickness (nausea and vomiting prevention)

Take a single dose 30 minutes before travel (Mills and Bone 2005; ESCOP 2003)
Take every 4 hours as needed (Optional) (Riebenfeld and Borzone 1999; Schmid et al. 1994).

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.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Product Ingredient 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 requirements outlined in the NHPID.

Ginger - Zingiber officinale Page 3 of 5


References cited

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.

Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR):


Eclectic Medical Publications; 1983 [Reprint of 1919 original].

ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products,
2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.

Felter HW, Lloyd JU. King’s American Dispensatory, Volume 2, 18th edition. Sandy (OR):
Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Grøntved A, Brask T, Kambskard J, Hentzer E. Ginger root against seasickness; a controlled trial
on the open sea. Acta Otolaryngology 1988;105:45-49.

Lien HC, Sun WM, Chen YH, Kim H, Hasler W, Owyang C. Effects of ginger on motion
sickness and gastric slow-wave dysrhythmias induced by circular vection. American Journal of
Physiology, Gastrointestinal and Liver Physiology 2003;284(3):G481-G489.

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. 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.

Mowrey DB, Clayson DE. Motion sickness, ginger, and psychophysics. Lancet 1982;1(8273):
655-657.

Riebenfeld D, Borzone L. Randomized double-blind study comparing ginger (Zintona ®) and


dimenhydrinate in motion sickness. European Phytotherapy 1999;2(6):98-101.

Schmid R, Schick T, Steffen R, Tschopp A, Wilk T.Comparison of seven commonly used agents
for prophylaxis of seasickness. Journal of Travel Medicine 1994;1(4):203-206.

USDA 2018: ARS, National Genetic Resources Program. Germplasm Resources Information
Network (GRIN). Zingiber officinale Roscoe. National Germplasm Resources Laboratory,
Beltsville (MD). [Accessed 2018 August 14]. Available at: http://www.ars-grin.gov/cgi-
bin/npgs/html/taxon.pl?42254

WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants,
Volume 1. Geneva (CHE): World Health Organization; 1999.

Ginger - Zingiber officinale Page 4 of 5


Wiersema JH, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC
Press LLC; 1999.

Wren RC. Potter’s Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and
Clark; 1907.

References reviewed

Backon J. Ginger as an antiemetic: possible side effects due to its thromboxane synthetase
activity. Anaesthesia 1991;46(8):705-706.

Bordia A, Verma SK, Srivastava KC. Effect of ginger (Zingiber officinale Rosc.) and fenugreek
(Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients
with coronary artery disease. Prostaglandins, Leukotrienes and Essential Fatty Acids
1997;56(5):379-84.

Careddu P. Motion sickness in children: Results of a double-blind study with ginger (Zintona R)
and dimenhydrinate. European Phytotherapy 1999;6(2):102-7.

Fischer-Rasmussen W, Kjaer SK, Dahl C, Asping U. Ginger treatment of hyperemesis gravidarum.


European Journal of Obstetrics & Gynecology and Reproductive Biology 1990;38:19-24.

Jiang X, Williams KM, Liauw WS, Ammit AJ, Roufogalis BD, Duke CC, Day RO, McLachlan
AJ. Effect of ginkgo and ginger on the pharmacokinetics and pharmacodynamics of warfarin in
healthy subjects. British Journal of Clinical Pharmacology 2005;59(4):425-32.

Krüth P, Brosi E, Fux R, Mörike K, Gleiter CH. Ginger-associated overanticoagulation by


phenprocoumon. The Annals of Pharmacotherapy 2004;38(2):257-260.

Lumb AB. Effect of dried ginger on human platelet function. Thrombosis and Haemostasis
1994;71(1):110-111.

Srivastava KC. Effects of onion and ginger consumption on platelet thromboxane production in
humans. Prostaglandins, Leukotrienes and Essential Fatty Acids 1989; 35(3):183-185.

Ginger - Zingiber officinale Page 5 of 5

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