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KMID : 1234920200200020138
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Journal of Korean Oriental Association for Study of Obesity
2020 Volume.20 No. 2 p.138 ~ p.148
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The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial
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Oh Ji-Hong
Shim Hye-Yoon
Cha Ji-Yun
Kim Ho-Seok
Kim Min-Ji
Ahn Eun-Kyung
Lee Myeong-Jong
Lee Jun-Hwan
Kim Ho-Jun
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Abstract
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Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers.
Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12.
Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.
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KEYWORD
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Obesity, Korea traditional medicine, Randomized controlled trial, Herbal medicine
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