TRIPHALA

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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

Date

February 25, 2019

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

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

Phyllanthus emblica

  • Amalaki
  • Amla
  • Emblic
  • Emblic myrobolan
  • Indian gooseberry
  • Myrobolan

Phyllanthus emblica

Fruit

Dried

Terminalia chebula

  • Harad
  • Haritaki

Terminalia chebula

Fruit

Dried

Terminalia bellirica

  • Beach-almond
  • Beleric myrobolan
  • Belleric
  • Belleric myrobolan
  • Bibhitaki
  • Bohera
  • Myrobolan

Terminalia bellirica

Fruit

Dried

References: Proper names: IT IS 2018, USDA 2018, API 2001, McGuffin et al. 2000; Common names: ITIS 2018, USDA 2018, Martindale 2011, API 2001, McGuffin et al. 2000; Source information: API 2001, Kapoor 2001, Khory and Katrak 1999, Nadkarni 1954.

Route of Administration

Oral

Dosage Form(s)

This monograph is not intended to include 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)

All products Products containing Triphala and/or Amalaki and/or Haritaki Products containing Amalaki Products containing Haritaki and/or Bibhitaki Products containing Haritaki

Traditionally used in Ayurveda to help relieve colic pain and flatulence (carminative) (Sukh Dev 2006; Khare 2004).

Permitted combinations

All ingredients included in this monograph may be combined together as long as combined dose is within the dose limits indicated below.

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)

Antioxidants

Methods of preparation: Dry, Powder, Non-standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Not to exceed 6 grams of Amalaki, per day (API 2001).

Rasayana; Digestive tonic; Eye tonic

Methods of preparation: Dry, Powder, Non-standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Table 2: Dose information presented as dose per day
Medicinal Ingredients Dried fruit (grams/day)
Minimum Maximum

Amalaki

3

6

Haritaki

1

3

Bibhitaka

1

3

Amalaki + Haritaki + Bibhitaki (Triphala)

1

3

Amalaki + Haritaki or Bibhitaki

2

3

Haritaki + Bibhitaki

1

3

References: Amalaki: API 2001; Haritaki: Williamson 2002, API 2001, Gogte 2000; Bibhitaki: Williamson 2002, API 2001, Gogte 2000: Triphala: Tilloston et al. 2001, Gogte 2000; Amalaki + Haritaki or Bibhitaki: API 2001, Gogte 2000; Haritaki + Bibhitaki: Tilloston et al. 2001, Gogte 2000.

Laxative; Amlapitta; Carminative; Cough; Vermifuge

Methods of preparation: Dry, Powder, Non-standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Table 3: Dose information presented as dose per day
Medicinal Ingredients Dried fruit (grams/day)
Minimum Maximum

Amalaki

3

6

Haritaki

2

6

Bibhitaka

3

6

Amalaki + Haritaki + Bibhitaki (Triphala)

2

6

Any 2 combined together

3

6

References: Amalaki: API 2001; Haritaki: API 2001, Murthy 1994; Bibhitaki: API 2001: Triphala (Amalaki +Haritaki + Bibhitaki): Tilloston et al. 2001, Murthy 1994; Any 2 combined together: Murthy 199

Direction(s) for use

All Products

Take 2 hours before or after taking other medications (HC 2009; Martindale 2008).

Laxative

Allow at least 6 to 12 hours for laxative effect to occur (APhA 2002).

Duration(s) of Use

Laxative; Vermifuge

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days (HC 2009; Pray 2006; CPhA 2002).

Vermifuge

For occasional use only.

Risk Information

Caution(s) and warning(s)

All products

Amlapitta; Stomachic; Laxative; Cough; Carminative; Vermifuge

Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Products providing more than 4 g of Triphala dried fruit or more than 4 g of Haritaki dried fruit

Contraindication(s)

Products providing more than 4 g of Triphala dried fruit or more than 4 g of Haritaki dried fruit

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 such as Crohn's disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes (Murthy 2004; McGuffin et al. 1997).

Known adverse reaction(s)

All products except those making laxative claim

Stop use if laxative effect occurs.

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

References Cited