Zhongguo quanke yixue (Jul 2022)

Thoughts on Key Factors of Clinical Trial Protocol Design for Chronic Atrophic Gastritis Treated with Traditional Chinese Drugs

  • Tianyuan WANG, Bo LI, Guozhen ZHAO, Jing HU, Hong WANG, Shuo FENG, Huina ZHANG

DOI
https://doi.org/10.12114/j.issn.1007-9572.2022.0065
Journal volume & issue
Vol. 25, no. 20
pp. 2519 – 2524

Abstract

Read online

Traditional Chinese Drugs has proven to have unique merits in treating chronic atrophic gastritis (CAG) , but needs to be verified further by high-quality large-sample clinical studies. We detailed the technique essentials of clinical trial protocol design and assessment for CAG treated with Traditional Chinese Drugs, which may be used as a methodological reference for clinical trial protocol design for CAG treated using Traditional Chinese Drugs, promoting the quality improvement of relevant studies. Then we discussed the essentials of relevant clinical trial protocol design, especially the selection of outcome indicators, in accordance with the attributes of Traditional Chinese Drugs, and features and actual needs of such trials, providing ideas for comprehensive evaluation of efficacy of Traditional Chinese Drugs in treating CAG.

Keywords