1. Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial.
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Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko, Cheon, Chunhoo, Jang, Soobin, Park, Jeong-Su, Ko, Youme, Kim, Doh Sun, Lee, Byung Hoon, Song, Hyun Jong, Song, Yun-Kyung, and Jang, Bo-Hyoung
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HERBAL medicine , *OBESITY treatment , *KOREAN medicine , *RANDOMIZED controlled trials , *PLACEBOS , *ADIPOSE tissues , *HUMAN body composition , *COMPARATIVE studies , *EXPERIMENTAL design , *FOOD habits , *LIPIDS , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH protocols , *CHINESE medicine , *OBESITY , *PSYCHOLOGICAL tests , *QUALITY of life , *QUESTIONNAIRES , *RESEARCH , *SOCIAL participation , *TIME , *WEIGHT loss , *ANTIOBESITY agents , *EVALUATION research , *BODY mass index , *TREATMENT effectiveness , *BLIND experiment , *WAIST-hip ratio , *DIAGNOSIS , *THERAPEUTICS - 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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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