Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial
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 (X...
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05050-w |
| _version_ | 1818412695202824192 |
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| author | Geng Li Zhe Zhang Li Zhou Shaojun Liao Jing Sun Yinghua Liu Xin Wang Zehuai Wen |
| author_facet | Geng Li Zhe Zhang Li Zhou Shaojun Liao Jing Sun Yinghua Liu Xin Wang Zehuai Wen |
| author_sort | Geng Li |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-14T10:51:24Z |
| format | Article |
| id | doaj.art-f676bfe15e5f4c579e753187df32b01e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T10:51:24Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f676bfe15e5f4c579e753187df32b01e2022-12-21T23:05:14ZengBMCTrials1745-62152021-01-012211910.1186/s13063-021-05050-wChinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trialGeng Li0Zhe Zhang1Li Zhou2Shaojun Liao3Jing Sun4Yinghua Liu5Xin Wang6Zehuai Wen7The Second Affiliated Hospital of Guangzhou University of Chinese MedicineLiaoning University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Chinese MedicineThe Second Clinical College of Guangzhou University of Chinese MedicineDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese MedicineDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese MedicineDepartment of Obstetrics and Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese MedicineThe Second Affiliated Hospital of Guangzhou University of Chinese MedicineAbstract 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 2019https://doi.org/10.1186/s13063-021-05050-wChinese herbal medicinePrimary dysmenorrheaXuefu Zhuyu Oral LiquidPlaceboRandomized controlled trial |
| spellingShingle | Geng Li Zhe Zhang Li Zhou Shaojun Liao Jing Sun Yinghua Liu Xin Wang Zehuai Wen Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial Trials Chinese herbal medicine Primary dysmenorrhea Xuefu Zhuyu Oral Liquid Placebo Randomized controlled trial |
| title | Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial |
| title_full | Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial |
| title_fullStr | Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial |
| title_full_unstemmed | Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial |
| title_short | Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial |
| title_sort | chinese herbal formula xuefu zhuyu for primary dysmenorrhea patients cherupdys a study protocol for a randomized placebo controlled trial |
| topic | Chinese herbal medicine Primary dysmenorrhea Xuefu Zhuyu Oral Liquid Placebo Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05050-w |
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