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. 2021 Jan 26;22(1):95.
doi: 10.1186/s13063-021-05050-w.

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

Geng Li #  1   2 , Zhe Zhang #  3 , Li Zhou  1   2 , Shaojun Liao  4 , Jing Sun  5 , Yinghua Liu  5 , Xin Wang  6 , Zehuai Wen  7   8   9   10
Affiliations

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

Geng Li et al. Trials. .

Abstract

Background: Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients.

Methods: This is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups-a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported.

Discussion: This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea.

Trial registration: Chinese Clinical Trial Registry ChiCTR1900026819 . Registered on 23 October 2019.

Keywords: Chinese herbal medicine; Placebo; Primary dysmenorrhea; Randomized controlled trial; Xuefu Zhuyu Oral Liquid.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram. VAS, visual analog scale; CMSS, Cox Menstrual Symptom Scale; AEs, adverse events
See this image and copyright information in PMC

References

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