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Journal of Traditional Chinese Medicine >

2023 , Vol. 43 >Issue 4: 815 - 823

DOI: https://doi.org/10.19852/j.cnki.jtcm.20230517.001

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

  • Wencong CAO ,
  • Shaojun LIAO ,
  • Yuanwen ZHANG ,
  • Li ZHOU ,
  • Geng LI ,
  • Wenwei OUYANG ,
  • Zehuai WEN
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  • 1 Second Clinical Medical College (Second Affiliated Hospital), Guangzhou University of Chinese Medicine, Guangzhou 510405, China
    2 First Clinical Medical College (First Affiliated Hospital), Guangzhou University of Chinese Medicine, Guangzhou 510405, China
    3 Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
    4 State Key Laboratory of Dampness Syndrome of Chinese Medicine, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
    5 Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou 510405, China

Received date: 2022-03-22

  Accepted date: 2022-07-19

  Online published: 2023-05-17

Supported by

National Key Research and Development Program of China: Research on “the Pattern Dominating Disease” of Post-market Evaluation on Two Classic Chinese Herbal Formulas based on Basket Design(2018YFC1707407)

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Abstract

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.

Key words： angina, stable; tension-type headache; primary dysmenorrhea; Chinese herbal formula; Chinese medicine pattern; master protocol

Cite this article

Wencong CAO , Shaojun LIAO , Yuanwen ZHANG , Li ZHOU , Geng LI , Wenwei OUYANG , Zehuai WEN . 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

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