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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
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
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1877-8) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: SPIRIT 2013 checklist. (DOCX 51 kb)
13063_2017_1877_MOESM1_ESM.docx
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