Efficacy and safety analysis of Kaiyu Jiangzhuo Tongzhi prescription for the treatment of pre-diabetic overweight/obese patients: A multicentre randomised controlled clinical study protocol and statistical analysis plan
Year: 2024
Type: article
Study design: Study Protocol
Abstract: The Chinese Academy of traditional Chinese medicine (TCM)’s academician Xiaolin Tong developed the Kaiyu Jiangzhuo Tongzhi prescription (KYJZ) in response to prediabetes’s “yu” mechanism. This study plans to thoroughly evaluate the safety and effectiveness of KYJZ in treating prediabetes and preventing diabetes mellitus. This study is a multicenter, randomized, double-blind, placebo-controlled trial in which 598 patients with pre-diabetes were randomly assigned in a 1:1 ratio to either the KYJZ or the placebo group. The primary outcome was to assess the incidence of diabetes at the end of 48 weeks. Secondary outcomes included the rate of normal conversion to glucose tolerance at the end of 48 weeks, indicators of glucose-fat metabolism, body mass index (BMI), waist circumference (WC), and Diabetes Symptom Rating Scale (DSRS), as well as body composition analysis (BCA) and diabetes risk score (DRS). Record all adverse events that occur and analyze the data collected. The results of this study will provide strong evidence for the efficacy and safety of KYJZ in reducing the incidence of diabetes mellitus in overweight/obese patients with prediabetes.
Authors: Xiaoxuan XU, Boxun ZHANG, Xue QU, Dongqi QU, Hang LIU, Wenlin ZHANG, Rui SUN, Linhua ZHAO, Jixiang REN, Ying ZHANG, Yangyang LIU
Institutions: Changchun University of Chinese Medicine, Chengdu University, Chengdu University of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Guang’anmen Hospital, The Affiliated Hospital to Changchun University of Chinese Medicine, Beijing University of Chinese Medicine
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4404804012