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

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.