Key technologies elements of clinical study of TCM new drugs on children's functional constipation

Abstract

Abstract: The evidence of relevant systematic reviews and randomized controlled trials was assessed and graded, combined with the clinical study practice to identify eleven key elements as a focus for the clinical study of TCM New Drugs on children's functional constipation:the primary purpose and design of the study, the inclusion and exclusion criteria of the study,the treatment,the trail procedure,the effectiveness and safety evaluation, and quality control as well. In addition, six recommendations for the design of clinical study of TCM New Drugs on Children's Functional Constipation were provided.

Key words: TCM New Drugs, Children's functional constipation, Clinical evaluation

CLC Number:

R969

ZHONG Cheng-liang, HU Si-yuan. Key technologies elements of clinical study of TCM new drugs on children's functional constipation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(9): 1025-1030.

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