ALOE - ALOE VERA - Oral

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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 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 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)
Aloe Vera	Aloe Barbados aloe Curaçao aloe True aloe West Indian aloe Aloe vera	Aloe Vera	Leaf Latex

References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000; Source material: Barnes et al. 2007, Williamson 2003

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 the age category listed in this monograph 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 a)] stimulant laxative (Williamson 2003; Bradley 1992; Felter and Lloyd 1983; Grieve 1971).
• (Used in Herbal Medicine for the) short-term relief of occasional constipation (EMEA 2006).
• (Used in Herbal Medicine to) promote(s) bowel movement (by direct action on the large intestine) (Sweetman 2007; EMEA 2006; WHO 1999).

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

• (Used in Herbal Medicine as a) stimulant laxative for short-term relief of occasional constipation (EMEA 2006).

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

Dose(s)

Subpopulation(s)

Adolescents 12 to 17 years and adults 18 years and older (EMEA 2006; Brinker 2001).

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

50-300 milligrams dried leaf latex, per day (Williamson 2003; Bradley 1992)

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

10-30 milligrams hydroxyanthracene derivatives (calculated as barbaloin/aloin), per day (Barnes et al. 2007; EMEA 2006; Blumenthal et al. 1998)

Direction(s) for use

• Allow at least 6-12 hours for laxative effect to occur (EMEA 2006; Berardi et al. 2002).
• Take a single dose at bedtime, a few hours before or after taking other medications or health products, two to three times per week. Frequency of use may be increased up to once daily if results are not observed (EMEA 2006; McGuffin et al. 1997; Bradley 1992).

Optional (for products which provide a dose range):

The correct individual dose is the smallest one required to produce a soft-formed stool (EMEA 2006).

Duration(s) of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days (EMEA 2006; Brinker 2001).

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 have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever (EMEA 2006; Brinker 2001; McGuffin et al. 1997).
• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a kidney disorder, or are taking cardiac medications (e.g. cardiac glycosides or antiarrhythmic medications) (EMEA 2006; Brinker 2001; McGuffin et al. 1997).
• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking thiazide diuretics, corticosteroids, licorice root, or other medications or health products that may aggravate electrolyte imbalance (EMEA 2006; Brinker 2001; McGuffin et al. 1997).
• Reduce dose or stop use if you experience abdominal pain, cramps, spasms and/or diarrhoea (EMEA 2006; Brinker 2001).

Contraindication(s)

• Do not use this product if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease (e.g. Crohn's disease or ulcerative colitis), abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes, hemorrhoids or diarrhoea (Brinker 2018; EMEA 2006; Brinker 2001; McGuffin et al. 1997).
• Do not use this product if you are pregnant or breastfeeding (Brinker 2001; McGuffin et al. 1997).

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Brinker 2018; EMEA 2006).

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

• Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press.
• Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to SelfCare, 13th edition. Washington (DC): American Pharmaceutical Association
• Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. 1998. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council.
• Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association.
• 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/
• Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
• EMEA 2006. European Medicines Agency. Community Herbal Monograph on Aloe Barbadensis Miller and on Aloe (Various Species, Mainly Aloe Ferox Miller And Its Hybrids). London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2018 June 5]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2009/12/WC500017826.pdf
• Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
• Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
• McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
• Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Aloe vera (L.) Burm. f. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2018 June 5]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CHE): World Health Organization.
• Williamson EM. 2003. Potter’s Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited.

References reviewed

• Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [Reprint of 1922 original].
• Gallagher J, Gray M. 2003. Is aloe vera effective for healing chronic wounds? Journal of Wound, Ostomy and Continence Nursing 30(2):68-71.
• Gerard J. 1975. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications.
• HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, Stimulating Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2018 October 8]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquetpharm/laxstimu-eng.php
• Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
• MacKay D, Miller AL. 2003. Nutritional support for wound healing. Alternative Medicine Review 8(4):359-377.
• Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. 2007. The efficacy of aloe vera used for burn wound healing: a systematic review. Burns 33(6):713-718.
• Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (UK): Thorsons Publishers Ltd.
• Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
• Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
• Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers.
• Vogler BK, Ernst E. 1999. Aloe vera: a systematic review of its clinical effectiveness. British Journal of General Practice 49(447):823-828.
• Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited.