title: Gyejibongneyong-hwan, a herbal medicine for the treatment of dysmenorrhoea with uterine fibroids: a protocol for a randomised controlled trial.
abstract: Gyejibongneyong-hwan (GBH), or the Guizhi Fuling Formula in Chinese, is widely used to treat uterine fibroids in East Asian countries including Korea, China and Japan. This study will assess the efficacy and safety of the GBH formula for the treatment of dysmenorrhoea.
  
  
  
  This study will be a randomised double-blind controlled trial with two parallel arms: the GBH group and the placebo group. This trial will recruit 38 women between 18 and 45 years of age with secondary dysmenorrhoea with uterine fibroids. The investigational drugs, either GBH or placebo, will be administered to the participants three times per day for two menstrual periods (8 weeks). The participants will be followed up for three menstrual cycles after administration of the drugs. The primary outcome will be the Numeric Rating Scale score of average menstrual pain. All analyses will be performed with SAS (V.9.1.3; SAS Institute, Cary, North Carolina, USA) by a statistician blinded to the allocation of the groups. Statistical analysis will be undertaken on the intent-to-treat (ITT) basis with a 95% CI using the last observation carried forward for missing values. The ITT analysis will include all randomised patients.
  
  
  
  This research protocol has been reviewed and approved by the institutional review boards of the trial centre (number WSOH IRB 1606-03). Written informed consent will be obtained from all study participants prior to enrolment in the study. The results will be published in a peer-reviewed journal and will be disseminated electronically and in print.
  
  
  
  KCT0001967.
authors.affiliation: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Jeeyoun
authors.initials: J
authors.lastname: Jung
authors.affiliation: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Ju Ah
authors.initials: JA
authors.lastname: Lee
authors.affiliation: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Mi Mi
authors.initials: MM
authors.lastname: Ko
authors.affiliation: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Sooseong
authors.initials: S
authors.lastname: You
authors.affiliation: Department of Obstetrics & Gynecology, College of Korean Medicine, Woo-Suk University, Jeonju, Korea.
authors.forename: Eunhee
authors.initials: E
authors.lastname: Lee
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Jiae
authors.initials: J
authors.lastname: Choi
authors.affiliation: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Byoung-Kab
authors.initials: BK
authors.lastname: Kang
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Myeong Soo
authors.identifier: 0000-0003-0987-9093
authors.initials: MS
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D004412:Dysmenorrhea / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy / Q000503:physiopathology*; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D009657:North Carolina; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; C525079:guizhi-fuling; C548755:gyeongshingangjeehwan
keywords: COMPLEMENTARY MEDICINE; GYNAECOLOGY; Gyejibongneyong-hwan, Guizhi Fuling, uterine fibroids, clinical trial, protocol