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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial

Authors: Jung-Eun Kim, Junghyo Cho, Ojin Kwon, Ae-Ran Kim, Hyo-Ju Park, So-Young Jung, Joo-Hee Kim, Mikyung Kim, Hye-Yoon Lee, Jun-Hwan Lee

Published in: Trials | Issue 1/2017

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Abstract

Background

The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women.

Methods/design

This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks. The primary outcome is the mean change in menopause rating scale score at 5 weeks after randomization. Secondary outcomes include the World Health Organization quality of life-BREF scores, degrees of upward movement of qi and lower abdominal resistance and tenderness, blood stasis pattern questionnaire scores, and results of blood tests including assays for lipid profile, high sensitivity C-reactive protein, follicle-stimulating hormone, and estradiol. The feasibility outcomes include recruitment and completion rates and adherence to medication.

Discussion

The results of this study will provide basic data for the design of a large-scale clinical trial for evaluating the efficacy of GFW in the treatment of climacteric syndrome in women.

Trial registration

Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040. Registered on 5 September 2016.
Appendix
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Metadata
Title
Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial
Authors
Jung-Eun Kim
Junghyo Cho
Ojin Kwon
Ae-Ran Kim
Hyo-Ju Park
So-Young Jung
Joo-Hee Kim
Mikyung Kim
Hye-Yoon Lee
Jun-Hwan Lee
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1877-8

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