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Trials
Published in: Trials 1/2012

Open Access 01-12-2012 | Study protocol

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

Authors: Jeong-Su Park, Sunju Park, Chun-Hoo Cheon, Ho-Yeon Go, Seung-Ho Sun, Yong-Cheol Shin, Bo-Hyoung Jang, Seong-Gyu Ko

Published in: Trials | Issue 1/2012

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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
Appendix
Available only for authorised users
Literature
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Proctor Michelle, Farquhar Cyntia: Diagnosis and management of dysmenorrhoea. BMJ. 2005, 332: 1134-8.CrossRef
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Kim HO, Lim SW, Woo HY, Kim KH: Premenstrual syndrome and dysmenorrhea in Korean adolescent girls. Korean Journal of Obstetrics and Gynecology. 2008, 51 (11): 1322-9.
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O'Connell K, Davis AR, Westhoff C: Self-treatment Patterns among Adolescent Girls with Dysmenorrhea. Journal of Pediatric and Adolescent Gynecology. 2006, 19 (4): 285-9. 10.1016/j.jpag.2006.05.004.CrossRefPubMed
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Durain D: Primary dysmenorrhea: Assessment and management update. Journal of Midwifery and Women's Health. 2004, 49 (6): 520-7.CrossRefPubMed
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Zhu X, Proctor M, Bensoussan A, Wu E, Smith CA: Chinese herbal medicine for primary dysmenorrhea. Cochrane Database of Systematic Reviews. 2008, Art. No.: CD005288. DOI: 10.1002/14651858.CD005288.pub3, 2
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Choi GY, Cho JH, Jang JB, Lee KS: Clinical Study on the Efficacy of Gyejibongnyeong-hwan in the Treatment of Menorrhalgia. Journal of Oriental Obstetrics & Gynecology. 2004, 17 (1): 178-86.
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Melzack R: The short-form McGill pain questionnaire. Pain. 1987, 30 (2): 191-7. 10.1016/0304-3959(87)91074-8.CrossRefPubMed
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Cox DJ, Meyer RG: Behavioral treatment parameters with primary dysmenorrhea. J Behav Med. 1978, 1: 297-310. 10.1007/BF00846681.CrossRefPubMed
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Yeh LL, Liu J-Y, Lin K-S, Liu Y-S, Chiou J-M: A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrheoea. PLos One. 2007, 2 (8): e219-CrossRef
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he Korean Society for Oriental Obstetrics & Gynecology: The Obstetrics & Gynecology in Oriental Medicine. Jeongdam. 2001
Metadata
Title
Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial
Authors
Jeong-Su Park
Sunju Park
Chun-Hoo Cheon
Ho-Yeon Go
Seung-Ho Sun
Yong-Cheol Shin
Bo-Hyoung Jang
Seong-Gyu Ko
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-3

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