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방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜
The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial
J Korean Med Obes Res 2020;20:138-48
Published online December 31, 2020;  https://doi.org/10.15429/jkomor.2020.20.2.138
Copyright © 2020 The Society of Korean Medicine for Obesity Research.

오지홍⋅심혜윤⋅차지윤1⋅김호석1⋅김민지1⋅안은경1⋅이명종⋅이준환1,2⋅김호준
Jihong Oh, Hyeyoon Shim, Jiyun Cha1, Ho Seok Kim1, Min Ji Kim1, Eun Kyung Ahn1, Myeong-Jong Lee, Jun-Hwan Lee1,2, Hojun Kim

동국대학교 한의과대학 한방재활의학교실, 1한국한의학연구원 임상의학부, 2과학기술연합대학원대학교(UST) 한의생명과학전공

Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University, 1Clinical Medicine Division, Korea Institute of Oriental Medicine, 2Korean Medicine Life Science, University of Science & Technology (UST)
Hojun Kim
Department of Rehabilitation Medicine of Korean Medicine, Dongguk University Ilsan Oriental Hospital, 27 Dongguk-ro, Ilsandong-gu, Goyang 10326, Korea
Tel: +82-31-961-9111
Fax: +82-31-961-9009
E-mail: kimklar@dongguk.ac.kr

Jun-Hwan Lee
Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseongdaero, Yuseong-gu, Daejeon 30542, Korea
Tel: +82-42-868-9693
Fax: +82-42-868-9395
E-mail: omdjun@kiom.re.kr
Received November 4, 2020; Revised November 26, 2020; Accepted December 1, 2020.
cc This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
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.
Keywords : Obesity, Korea traditional medicine, Randomized controlled trial, Herbal medicine


December 2020, 20 (2)
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