title: Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial.
abstract: Introduction. Functional dyspepsia (FD), a common upper gastrointestinal disease, is difficult to manage because of the limitations of current conventional treatments. Yukgunja-tang (YGJT) is widely used to treat FD in clinical practice in Korea, Japan, and China. However, YGJT significantly improves few symptoms of FD. In Korean medicine, FD is a well-known functional gastric disease that shows difference in the effect of herbal medicine depending on constitution or type of Korean medicine diagnosis. This study aims to investigate the efficacy of YGJT on FD patients classified by 3-dimensional facial measurement using a 3-dimensional facial shape diagnostic system (3-FSDS).Methods. A placebo-controlled, double-blind, randomized, two-center trial will be performed to evaluate the efficacy of YGJT on FD patients. Eligible subjects will be initially classified as two types by 3-dimensional facial measurement using the 3-FSDS. Ninety-six subjects (48 subjects per each type) will be enrolled. These subjects will be randomly allocated into treatment or control groups in a 2 : 1 ratio. YGJT or placebo will be administered to each group during the 8-week treatment period. The primary outcome is total dyspepsia symptom scale, and the secondary outcomes include single dyspepsia symptom scale, proportion of responders with adequate symptom relief, visual analog scale, Nepean dyspepsia index-Korean version, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire.Discussion. This is the first randomized controlled trial to assess the efficacy of the YGJT on FD patients classified by 3-dimensional facial measurement. We will compare the treatment effect of the YGJT on FD patients classified as two types using the 3-FSDS. The results of this trial will help the FD patients improve the symptoms and quality of life effectively and provide objective evidence for prescribing the YGJT to FD patients in clinical practice.Trial Registration. This trial is registered with Clinical Research Information Service Identifier: KCT0001920, 15 May, 2016.
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.
authors.forename: Juyeon
authors.identifier: 0000-0003-2921-5163
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.
authors.forename: Jae-Woo
authors.identifier: 0000-0002-1862-7317
authors.initials: JW
authors.lastname: Park
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.
authors.forename: Seok-Jae
authors.identifier: 0000-0002-9902-0938
authors.initials: SJ
authors.lastname: Ko
authors.affiliation: Department of Sasang Constitutional Medicine, College of Korean Medicine, Dong-Eui University, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea.
authors.forename: Soo-Hyung
authors.initials: SH
authors.lastname: Jeon
authors.affiliation: Department of Sasang Constitutional Medicine, College of Korean Medicine, Dong-Eui University, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea.
authors.forename: Jong-Won
authors.identifier: 0000-0001-6572-3734
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Department of Statistics, Sookmyung Women's University, Cheongpa-ro 47-gil 100, Youngsan-gu, Seoul 140-742, Republic of Korea.
authors.forename: Inkwon
authors.initials: I
authors.lastname: Yeo
authors.affiliation: Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea.
authors.forename: Jinsung
authors.identifier: 0000-0002-2164-357X
authors.initials: J
authors.lastname: Kim