Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Close this folder3. RESEARCH STUDIES
View the documentLITERATURE BACKGROUND
View the documentPROTOCOL PREPARATION
View the documentQUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
Open this folder and view contentsNON-CLINICAL STUDIES
Close this folderCLINICAL TRIALS USING HERBAL MEDICINES
View the documentCLINICAL TRIAL PROTOCOL DEVELOPMENT
View the documentPHASES OF A CLINICAL TRIAL
View the documentETHICS REVIEW BOARD
View the documentRESPONSIBILITIES OF INVESTIGATORS
View the documentRESPONSIBILITIES OF THE SPONSOR
View the documentDATA MANAGEMENT
View the documentSTATISTICAL ANALYSIS
View the documentREPORTING
View the documentEVALUATION OF HERBAL MEDICINE RESEARCH
Open this folder and view contentsTECHNOLOGY TRANSFER AND EDUCATION
Open this folder and view contents4. USING THE GUIDELINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

CLINICAL TRIALS USING HERBAL MEDICINES

These guidelines for the clinical evaluation of herbal medicines attempt to recognize the long and diverse history of traditional medicine in the Region and the differences between the diagnostic systems of modern medicine and the various traditional medicines of the Member States. Although special considerations may be required, the general principles of the clinical trials of herbal medicines are similar to those applied to synthetic drugs if clinical trial is regarded to be necessary.

Clinical trials of herbal medicines may have two types of objectives. One is to validate the safety and efficacy that is claimed for a traditional herbal medicine. The other is to develop new herbal medicines or examine a new indication for an existing herbal. medicine or a change of dose formulation, or route of administration. In some cases, trials may be designed to test the clinical activity of a purified or semi-purified compound derived from herbal medicines.

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