Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea:rationale and design of a master protocol
机构:[1]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Clin Med Coll 2, Guangzhou 510405, Peoples R China广东省中医院[2]Guangzhou Univ Chinese Med, Affiliated Hosp 1, Clin Med Coll 1, Guangzhou 510405, Peoples R China[3]Guangdong Prov Hosp Chinese Med, Key Unit Methodol Clin Res, Guangzhou 510120, Peoples R China广东省中医院[4]Guangzhou Univ Chinese Med, State Key Lab Dampness Syndrome Chinese Med, Affiliated Hosp 2, Guangzhou 510120, Peoples R China广东省中医院[5]Guangzhou Univ Chinese Med, Sci & Technol Innovat Ctr, Guangzhou 510405, Peoples R China
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 )43.19i5f, 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)
第一作者机构:[1]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Clin Med Coll 2, Guangzhou 510405, Peoples R China
通讯作者:
通讯机构:[3]Guangdong Prov Hosp Chinese Med, Key Unit Methodol Clin Res, Guangzhou 510120, Peoples R China[4]Guangzhou Univ Chinese Med, State Key Lab Dampness Syndrome Chinese Med, Affiliated Hosp 2, Guangzhou 510120, Peoples R China[5]Guangzhou Univ Chinese Med, Sci & Technol Innovat Ctr, Guangzhou 510405, Peoples R China[*1]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
推荐引用方式(GB/T 7714):
Cao Wencong,Liao Shaojun,Zhang Yuanwen,et al.Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea:rationale and design of a master protocol[J].JOURNAL OF TRADITIONAL CHINESE MEDICINE.2023,43(4):815-823.doi:10.19852/j.cnki.jtcm.20230517.001.
APA:
Cao, Wencong,Liao, Shaojun,Zhang, Yuanwen,Li, Zhou,Geng, Li...&Wen, Zehuai.(2023).Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea:rationale and design of a master protocol.JOURNAL OF TRADITIONAL CHINESE MEDICINE,43,(4)
MLA:
Cao, Wencong,et al."Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea:rationale and design of a master protocol".JOURNAL OF TRADITIONAL CHINESE MEDICINE 43..4(2023):815-823