title: A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial.
abstract: BACKGROUND
  Obesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases. In Korea and around the world, the prevalence of obesity has grown annually from 1998 to 2008. This growth has continued despite various therapeutic efforts. The discovery of new and alternative treatments for obesity should be considered an important priority. Taeumjowi-tang (TJ001), a traditional Korean medicinal extract consisting of eight herbs, is a widely used herbal remedy for obesity in Korea. However, the efficacy and safety of TJ001 have not been fully investigated in a clinical trial. The purpose of this pilot study is to estimate obesity-related parameters and to assess the efficacy and safety of TJ001.
  
  
  METHODS
  Our study is a randomised, double-blind, placebo-controlled, multicentre clinical trial of Taeumjowi-tang (TJ001). For this study, we will recruit obese Korean patients of both sexes, ages 18 to 65 years, from four university hospitals. A total of 104 subjects will be recruited. The participants will receive either 7 g of TJ001 or a placebo three times daily for 12 weeks. The primary end point will be the rate of subjects who lose at least 5% of their baseline body weight. The secondary end points will be changes in body weight, body mass index, waist circumference, hip circumference, waist/hip circumference ratio, lipid profiles, body fat composition, blood pressure, fasting glucose concentration, C-reactive protein and questionnaires related to the quality of life. The outcomes will be measured every 4 weeks. The study period will be 12 weeks and will include a total of five visits with each subject (at screening and at 0, 4, 8 and 12 weeks).
  
  
  CONCLUSIONS
  The results of our study will inform various estimates of TJ001 and will serve as the basis for a larger-scale trial. This study will assess the efficacy and safety of TJ001 as an alternative herbal remedy for obesity.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN87153759.
authors.affiliation: Center for Clinical Research and Genomics, College of Oriental Medicine and Institute of Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Sunju
authors.initials: S
authors.lastname: Park
authors.forename: Jeong-Su
authors.initials: JS
authors.lastname: Park
authors.forename: ChunHoo
authors.initials: C
authors.lastname: Cheon
authors.forename: Yong Joon
authors.initials: YJ
authors.lastname: Yang
authors.forename: Changsuk
authors.initials: C
authors.lastname: An
authors.forename: Bo-Hyoung
authors.initials: BH
authors.lastname: Jang
authors.forename: Yun-Kyung
authors.initials: YK
authors.lastname: Song
authors.forename: Hoyeon
authors.initials: H
authors.lastname: Go
authors.forename: Ju Ah
authors.initials: JA
authors.lastname: Lee
authors.forename: Yongcheol
authors.initials: Y
authors.lastname: Shin
authors.forename: Seong-Gyu
authors.initials: SG
authors.lastname: Ko
mesh_terms: D000886:Anthropometry; D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D055670:Medicine, Korean Traditional; D009765:Obesity / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D018401:Sample Size
chemical_list: D010936:Plant Extracts