Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial

Trials

Byung Hoon Lee¹  Hyun Jong Song¹  Yun-Kyung Song²  Chunhoo Cheon³  Doh Sun Kim³  Bo-Hyoung Jang³  Yong-Cheol Shin³  Seong-Gyu Ko³  Soobin Jang³  Youme Ko³  Jeong-Su Park⁴ 

[1] Department of Applied Korean Medicine, Graduate School, Kyung Hee University;Department of Korean Medicine Rehabilitation, College of Korean Medicine, Gachon University;Department of Korean Preventive Medicine, Graduate School, Kyung Hee University;Department of Korean Preventive Medicine, Semyung University;

关键词: Euiiyin-tang;    Obesity;    Sasang constitution;    Herbal medicines;    Randomised controlled trial;   

DOI  :  10.1186/s13063-017-2039-8

来源: DOAJ

【 摘 要 】

Abstract Background Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity. Methods/design This study is a randomised, double-blinded and placebo-controlled, multicentre trial. It has two parallel arms: the Euiiyin-tang group and the placebo group. A total of 160 obese adult women will be enrolled in the trial. The participants will be randomly divided at a 1:1 ratio at visit 2 (baseline). The participants will be administered Euiiyin-tang or placebo for 12 weeks. The primary endpoint is the change in weight occurring between baseline and post-treatment. The secondary outcomes include average weight reduction, changes in body fat, waist and hip circumferences, body mass index, and lipid profile, and the results of questionnaires such as the Korean version of Obesity-related Quality of Life, the Korean version of Eating Attitudes Test, the Social Readjustment Rating Scale, and the Stress Reaction Inventory. Discussion The present study will provide research methodologies for evaluating the efficacy and safety of Euiiyin-tang in patients with obesity. In addition, it will provide evidence of correlation between obesity and Sasang constitutional medicine. Trial registration ClinicalTrials.gov, NCT01724099 . Registered on 2 November 2012.

【 授权许可】

Unknown