Some problems in clinical trials design of new traditional Chinese medicine

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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2005, Vol. 10 ›› Issue (9): 1073-1075.

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Some problems in clinical trials design of new traditional Chinese medicine

DU Bao-jun

Clinical Pharmacological Base, Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China

Received:2005-07-26 Revised:2005-08-16 Published:2020-11-22

Abstract

Abstract: Some problems of clinical trial design of new traditional Chinese medicine were discussed in this article, including the establishment of TCM syndromes, the determination of efficacy level, the implement of different stage of clinical trial, the selection of diagnose standard and efficacy effect standard, the use of placebo, and the safety evaluation.

Key words: new traditional Chinese medicine, clinical trial, clinical trial-design, GCP, discussion of related problems

CLC Number:

R969

DU Bao-jun. Some problems in clinical trials design of new traditional Chinese medicine[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(9): 1073-1075.

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Some problems in clinical trials design of new traditional Chinese medicine

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