Placebo Preparation for the Proper Clinical Trial of Herbal Medicine - Requirements, Verification and Quality Control

Cheng      K. Fai; Guan      De Qi; Ding      A. Wei; Leung      P. Chung

Abstract

Randomized controlled trials (RCT) have been recognized as the gold standard for interventional clinical trials. In many clinical trials of herbal medicine, it is very difficult to create a quality placebo. To achieve the purpose of blinding, the characteristics of the real drug and placebo should be identical in color, appearance, smell and taste. The quality placebo should be identical to the real drug in physical form, sensory perception, packaging, and labeling, and it should have no pharmaceutical activity. The aim of this study was to evaluate a placebo capsule and its matching herbal medicine D capsule in physical form, chemical nature, appearance, packaging and labeling. The assessment results suggested that the placebo was satisfactory in these aspects. The results demonstrated that a placebo could be created for a RCT involving herbal medicine. This report also discusses the means to acquire patent.

Keywords: Chinese medicine, clinical trial, placebo, quality, evaluation, Herbal Medicine, Randomized controlled trials, herbal placebo, TLC analysis, trial-and-error technique, cognitive disorder, cerebrovascular diseases, randomized trials