Cheon Chunhoo, Jang Soobin, Park Jeong-Su, Ko Youme, Kim Doh Sun, Lee Byung Hoon, Song Hyun Jong, Song Yun-Kyung, Jang Bo-Hyoung, Shin Yong-Cheol, Ko Seong-Gyu
Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Trials. 2017 Jun 21;18(1):289. doi: 10.1186/s13063-017-2039-8.
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.
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.
ClinicalTrials.gov, NCT01724099 . Registered on 2 November 2012.
由于肥胖症患病率不断上升，它已成为许多国家关注的公共卫生问题。乙音汤是一种常用于肥胖症临床治疗的中药配方。它的作用是祛湿和净化血液，这是韩医学理论框架中确定的肥胖成因。本研究的目的是评估乙音汤治疗肥胖症的疗效和安全性。
方法/设计：本研究是一项随机、双盲、安慰剂对照的多中心试验。它有两个平行组：乙音汤组和安慰剂组。共有160名肥胖成年女性将参与该试验。参与者将在第2次就诊（基线）时按1:1的比例随机分组。参与者将接受乙音汤或安慰剂治疗12周。主要终点是基线与治疗后之间体重的变化。次要结果包括平均体重减轻、体脂、腰围和臀围的变化、体重指数和血脂谱，以及韩国版肥胖相关生活质量、韩国版饮食态度测试、社会再适应评定量表和应激反应量表等问卷的结果。
本研究将为评估乙音汤对肥胖症患者的疗效和安全性提供研究方法。此外，它将提供肥胖症与四象体质医学之间相关性的证据。
ClinicalTrials.gov，NCT01724099。于2012年11月2日注册。
