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Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial

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机构: [1]Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China [2]Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China [3]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou,Guangdong, China [4]Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China [5]Department of Neurology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang,Liaoning, China [6]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou,Guangdong, China [7]State Key Laboratory of Dampness Syndrome of Chinese Medicine,Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
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Background. Tension-type headache (TTH) is the most common headache disorder. Current treatments for TTH have been reported to be associated with insufficient long-term benefits and unwanted adverse events (AEs). The Chinese herbal formula Xuefu Zhuyu (XFZY) has been utilized in TTH treatment, but the evidence supporting its efficacy remains unclear. This study will evaluate the efficacy and safety of XFZY for TTH. Methods. This multicenter, double-blind, randomized, placebo-controlled trial will be undertaken in China. A total of 174 eligible participants will be randomly assigned to either an XFZY group or a placebo group (20 ml each dose, three times daily for 4 weeks) at a ratio of 1: 1. The primary outcome is the change in mean headache intensity measured by a 10 cm visual analogue scale (VAS). Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use, qi-stagnation and blood-stasis pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes. Discussion. The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of XFZY for TTH. This trail is registered with ChiCTR1900026716 (registered on 19 October, 2019). © 2020 Li Zhou et al.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 3 区 全科医学与补充医学
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Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
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第一作者机构: [1]Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China [2]Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China [3]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou,Guangdong, China
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通讯机构: [2]Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China [3]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou,Guangdong, China [6]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou,Guangdong, China [7]State Key Laboratory of Dampness Syndrome of Chinese Medicine,Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
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