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Open Access Study protocol

Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

Jeong-Su Park12, Sunju Park12, Chun-Hoo Cheon12, Ho-Yeon Go3, Seung-Ho Sun4, Yong-Cheol Shin2, Bo-Hyoung Jang12 and Seong-Gyu Ko12*

Author Affiliations

1 Center for Clinical Research and Genomics, Oriental Medical College, Kyung Hee University, Seoul, Republic of Korea

2 Department of Preventive Medicine, Oriental Medical College, Kyung Hee University, Seoul, Republic of Korea

3 Department of Oriental Internal Medicine, Korean Medicine College, Semyung University, Chungju, Republic of Korea

4 Department of Oriental Internal Medicine, Korean Medicine College, Sangji University, Wonju, Republic of Korea

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Trials 2012, 13:3  doi:10.1186/1745-6215-13-3

Published: 5 January 2012

Abstract

Background

Gyejibongnyeong-hwan (GJBNH) is one of the most popular Korean medicine formulas for menstrual pain of dysmenorrhea. The concept of blood stagnation in Korean medicine is considered the main factor of causing abdominal pain, or cramps, during menstrual periods. To treat the symptoms, GJBNH is used to fluidify the stagnated blood and induce the blood flow to be smooth, reducing pain as the result. The purpose of this trial is to identify the efficacy of GJBNH in dysmenorrhea caused by blood stagnation.

Methods

This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35) will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline), all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1) through the second follow-up (Visit 6) the entire process will take 25 weeks.

Discussion

This trial will provide evidence for the effectiveness of GJBNH in treating periodical pain due to dysmenorrhea that is caused by blood stagnation. The primary outcome between the two groups will be measured by changes in the Visual Analogue Score (VAS) of pain. The secondary outcome will be measured by the Blood Stagnation Scale, the Short-form McGill questionnaire and the COX menstrual symptom scale. Analysis of covariance (ANCOVA) and repeated measured ANOVA will be used to analyze the data analysis.

Trial registration

Current Controlled Trials: ISRCTN30426947