1.Explanation for the Methodological Framework for Interventional Clinical Research of Chinese Medicine under the Research Mode of Syndrome Dominating Disease
Qian HUANG ; Li ZHOU ; Meiling XUAN ; Xiaohui GUO ; Xingying QIU ; Bingqing LIU ; Wencong CAO ; Zehuai WEN
Journal of Traditional Chinese Medicine 2024;65(13):1328-1333
The methodological framework for interventional clinical research of Chinese medicine （CM） under the research mode of syndrome dominating disease provides a set of technical principles and methods to design， evaluate， and implement of this kind. It consists of three main parts including general principles， research points and key design elements， with a total of 25 items. This methodological framework proposes implementing requirements and recommendations in a variety of aspects， including basic norms to be followed in relevant studies， perspectives for selecting research topics， as well as the technological details on study population （P）， intervention （I） and comparison（C）， outcome measurement （O）， time frame （T） of treatment and follow-up， sample orientation （prospective versus retrospective）， study design （S） format and type. To provide practical guidance for future studies， this article clearly explains each items of the methodological framework through some supportive cases.
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