Introduction. Functional dyspepsia (FD), a common upper gastrointestinal disease, is difficult to manage because of the limitations\nof current conventional treatments. Yukgunja-tang (YGJT) is widely used to treat FD in clinical practice in Korea, Japan, and China.\nHowever, YGJT significantly improves few symptoms of FD. In Korean medicine, FDis a well-known functional gastric disease that\nshows difference in the effect of herbal medicine depending on constitution or type of Korean medicine diagnosis. This study aims\nto investigate the efficacy of YGJT on FD patients classified by 3-dimensional facial measurement using a 3-dimensional facial shape\ndiagnostic system (3-FSDS). Methods.Aplacebo-controlled, double-blind, randomized, two-center trial will be performed to evaluate\nthe efficacy of YGJT on FDpatients. Eligible subjects will be initially classified as two types by 3-dimensional facial measurement\nusing the 3-FSDS. Ninety-six subjects (48 subjects per each type) will be enrolled.These subjects will be randomly allocated into\ntreatment or control groups in a 2 : 1 ratio. YGJT or placebo will be administered to each group during the 8-week treatment period.\nThe primary outcome is total dyspepsia symptom scale, and the secondary outcomes include single dyspepsia symptom scale,\nproportion of responders with adequate symptom relief, visual analog scale, Nepean dyspepsia index-Korean version, functional\ndyspepsia-related quality of life, and spleen qi deficiency questionnaire. Discussion.This is the first randomized controlled trial to\nassess the efficacy of the YGJT on FD patients classified by 3-dimensional facial measurement.We will compare the treatment effect\nof 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\nsymptoms and quality of life effectively and provide objective evidence for prescribing the YGJT to FD patients in clinical practice.\nTrial Registration. This trial is registered with Clinical Research Information Service Identifier: KCT0001920, 15 May, 2016.
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