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http://dx.doi.org/10.22246/jikm.2022.43.6.1105

Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial  

Boram Lee (KM Science Research Division, Korea Institute of Oriental Medicine)
Min-Jin Cho (Dept. of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University)
Young-Eun Choi (Clinical Research Coordinating Team, Korea Institute of Oriental Medicine)
Ojin Kwon (KM Science Research Division, Korea Institute of Oriental Medicine)
Mi Young Lim (Personalized Diet Research Group, Food Functionality Research Division, Korea Food Research Institute)
Seok-Jae Ko (Dept. of Gastroenterology, College of Korean Medicine, Kyung Hee University)
So-yeon Kim (Dept. of Korean Internal Medicine, Korean Medicine Hospital of Pusan National University)
Yongjoo Kim (Dept. of Herbal Medicine, College of Korean Medicine, Sangji University)
Donghyun Nam (Dept. of Diagnostics and Biofunctional Medicine, College of Korean Medicine, Sangji University)
Dong-Jun Choi (Dept. of Internal Korean Medicine, Dongguk University Ilsan Oriental Medical Hospital)
Jun-Hwan Lee (KM Science Research Division, Korea Institute of Oriental Medicine)
Jae-Woo Park (Dept. of Gastroenterology, College of Korean Medicine, Kyung Hee University)
Hojun Kim (Dept. of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Dongguk University)
Publication Information
The Journal of Internal Korean Medicine / v.43, no.6, 2022 , pp. 1105-1121 More about this Journal
Abstract
Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.
Keywords
functional dyspepsia; pattern identification; herbal medicine; protocol; randomized controlled trial;
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Times Cited By KSCI : 9  (Citation Analysis)
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