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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

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收录情况: ◇ SCIE ◇ CSCD-C ◇ 卓越:梯队期刊

机构: [1]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Clin Med Coll 2, Guangzhou 510405, Peoples R China [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 [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
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关键词: angina stable tension-type headache primary dysmenorrhea Chinese herbal formula Chinese medicine pattern master protocol

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 )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.

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出版当年[2022]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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出版当年[2021]版:
Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
最新[2023]版:
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

影响因子: 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

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第一作者机构: [1]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Clin Med Coll 2, Guangzhou 510405, Peoples R China
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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
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