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Learn more about In Review
Study protocol
Yanan Luo
China Three Gorges University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8345-6270
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Primary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.
Methods and analysis
This study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.
Discussion
This is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.
Trial registration
Chinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.
Keywords
Guizhi Fuling Wan, Primary dysmenorrhea, Randomized controlled trial, Placebo control
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Posted 27 Apr, 2021
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Yanan Luo
China Three Gorges University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8345-6270
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 27 Apr, 2021
No community comments so far
Editor assigned
On 25 Apr, 2021
Submission checks complete
On 25 Apr, 2021
First submitted
On 13 Apr, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Primary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.
Methods and analysis
This study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.
Discussion
This is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.
Trial registration
Chinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.
Figure 1
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