title: Placebo preparation for the proper clinical trial of herbal medicine--requirements, verification and quality control.
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&G 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.
authors: Institute of Chinese Medicine, Chinese University of Hong Kong, Hong Kong.
authors: Cheng K
authors: CK
authors: Fai
authors: Guan De
authors: GD
authors: Qi
authors: Ding A
authors: DA
authors: Wei
authors: Leung P
authors: LP
authors: Chung
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002214:Capsules; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D004311:Double-Blind Method; D004348:Drug Labeling / Q000592:standards; D004349:Drug Packaging / Q000592:standards; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010330:Patents as Topic; D015990:Placebo Effect; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012903:Smell; D055815:Young Adult
chemical_list: D002214:Capsules; D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal