[MPWG] Clinical protocol for herbs/plants

[JPS Kohli]

Clinical testing would be performed along the lines of pharmacological classification and hence the type of formulation tested is not the main criteria. Therefore you would be hard-pressed to find specific info on herbal teas. I would suggest locating info on the testing of pharmacological action of any herbal tea that is to be tested.

1. An excellent although old source for clinical guidelines for herbal medicines would be a publication of WHO titled: 

Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

2. Latest and current information on clinical protocols have been provided in three chapters of the book "GMP for Botanicals":

a. Pharmacological evaluation of herbal drug development
b. Clinical trials of herbal medicine
c. Role of bioassays in development of natural products

3. In-depth and detailed guidelines have been provided in three chapters of the book "Quality Control of Herbal Drugs"

a. Pharmacological screening of herbal drugs (includes 22 categories like antidiabetic, hepatoprotective, diuretic, wound-healing etc.)
b. Antimicrobial and parasiticidal screening of herbal drugs
c. Screening for antiviral activity

These books can be purchased from www.Amazon.com

Actually, there is very little information on clinical evaluation procedures specifically for herbal medicines available in any other book. Maybe this could be an opportunity for a noteworthy trade or scientific organization to come up and develop just such guidelines to help herbal manufacturers better cope with the contemporary regulatory requirements of herbal products as "Medicines" rather than as "food supplements".

J P S Kohli (B. Pharm)
Business Horizons
Pharmaceutical Publishers
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New Delhi - 110 048, INDIA

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