摘要
We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.
基金
the National Key Research and Development Program of China:Research on“the Pattern Dominating Disease”of Postmarket Evaluation on Two Classic Chinese Herbal Formulas based on Basket Design(No.2018YFC1707407)。
