The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial (방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜)

Jihong Oh (오지홍); Hyeyoon Shim (심혜윤); Jiyun Cha (차지윤); Ho Seok Kim (김호석); Min Ji Kim (김민지); Eun Kyung Ahn (안은경); Myeong-Jong Lee (이명종); Jun-Hwan Lee (이준환); Hojun Kim (김호준)

doi:10.15429/jkomor.2020.20.2.138

The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial

Journal of Korean Medicine for Obesity Research
Abbr : J Korean Med Obes Res
2020, 20(2), pp.138-148
DOI : 10.15429/jkomor.2020.20.2.138
Publisher : The Society of Korean Medicine for Obesity Research
Research Area : Medicine and Pharmacy > Korean Medicine
Received : November 4, 2020
Accepted : December 1, 2020
Published : December 30, 2020

Jihong Oh ¹, Hyeyoon Shim ², Jiyun Cha ³, Ho Seok Kim ³, Min Ji Kim ³, Eun Kyung Ahn ³, Myeong-Jong Lee ², Jun-Hwan Lee ³, Hojun Kim ²

¹동의대학교 한의과대학 한방재활의학교실
²동국대학교 한의과대학 한방재활의학교실
³한국한의학연구원 임상의학부

Accredited

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

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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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The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial

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