Abstract
BackgroundThis study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern.Methods/designThis is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure will be the mean change in the Menopause Rating Scale from baseline to week 5. Secondary outcome measures will include the World Health Organization Quality of Life-BREF (WHOQOL-BREF) score, the Blood Deficiency Scoring System score, lean body mass, and blood tests, including serum follicle-stimulating hormone and estradiol concentration. To assess the safety of DJS, a laboratory test will be conducted before and after treatment and the participants will be asked about any occurrence of adverse events every visit. The recruitment rate, completion rate, and medication adherence will also be calculated, to assess feasibility.DiscussionThe findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women.Trial registrationClinical Research Information Service (CRIS), Republic of Korea, KCT0002387. Registered on 25 July 2017.
Highlights
This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern
The findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women
The North American Menopausal Association has mentioned that herbal medicines such as DJS are widely used around the world as a means of nonhormonal therapy for the management of climacteric syndrome, but the lack of a scientific and clinical basis for this therapy remains [7]
Summary
Since its first description as a herbal prescription for all kinds of female abdominal diseases in an old classical text of ancient Chinese medicine [33], DJS has been widely used in various conditions in gynecology in traditional East Asian medicine. There is still a lack of rigorously designed randomized controlled trials to assess the effects of DJS on climacteric syndrome in peri- and postmenopausal women, which is why we intend to explore the efficacy and safety of DJS and investigate the feasibility of a clinical study for this issue. We are working on another pilot study to evaluate the efficacy and safety of Gyejibongnyeonghwan ( called Guizhifulingwan or Keishibukuryogan in China and Japan) for the treatment of climacteric syndrome in peri- and postmenopausal women who are diagnosed with blood stasis patterns under the pattern identification system [12]. To ensure that these efforts were successful, we will assess the achievement of participant blinding after the end of the treatment period Another limitation is that the scale of this study is too small, and the duration of medication administration and follow-up is short.
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