None listed
Conditions
Interventions
Drug : The trial compares the group that administers herbal medicine based on artificial intelligence-based herbal medicine response prediction formula among Yijung-tang, Pyeongwi-san, and Sihosogan-t
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male or female adults aged between 19 and 75 years. (2) Meets the Rome IV criteria for functional dyspepsia: at least one of the following symptoms—postprandial fullness, early satiety, epigastric pain, or epigastric burning—must have begun at least 6 months prior to screening and persisted for the past 3 months, with no evidence of structural disease. (3) A dyspepsia severity score of =40 mm measured by a 0–100 mm Visual Analogue Scale (VAS). (4) Agrees not to receive any new treatments related to dyspepsia during the clinical trial period. (5) Has received a full explanation of the study, voluntarily agrees to participate, and signs a written informed consent form approved by the Institutional Review Board (IRB).
Exclusion criteria
Exclusion criteria: (1) Diagnosed within one year prior to screening with any organic gastrointestinal disease such as peptic ulcer, esophageal cancer, mucosa-associated lymphoid tissue lymphoma, gastric cancer, colorectal cancer, biliary or pancreatic diseases (asymptomatic cholelithiasis excluded), or inflammatory bowel disease. (2) Presence of symptoms of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS) that are more severe than dyspeptic symptoms. (3) Presence of alarm symptoms such as significant weight loss, hematochezia, dysphagia, odynophagia, or persistent vomiting. (4) History or current diagnosis of significant neurological or psychiatric disorders, including major depressive disorder, anxiety disorder, schizophrenia, anorexia nervosa, or epilepsy. (5) Presence of serious organic diseases such as heart failure, angina, myocardial infarction, arrhythmia, valvular disease, malignant tumors, or stroke. (6) History of gastrointestinal surgery (participants with a history of appendectomy more than 6 months prior may be eligible). (7) Use of medications that affect the gastrointestinal tract (e.g., proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, fundus relaxants, mucosal protective agents, anticholinergics, adsorbents, antiflatulents, antiemetics, emetics, gastrin receptor antagonists, prostaglandin analogs) or Helicobacter pylori eradication therapy within 2 weeks prior to screening. (8) Received traditional Korean medical treatments such as acupuncture, herbal medicine, or moxibustion for dyspepsia within 2 weeks prior to screening or plans to receive them during the study period. (9) Use of antibiotics within 3 months prior to screening. (10) Use of probiotic supplements within 1 month prior to screening (participants who have been on a consistent regimen for more than 1 month prior to screening and plan to maintain the same dose and frequency throughout the trial may be included). (11) Patients with severe hepatic or renal impairment (Aspartate Aminotransferase or Alanine Aminotransferase >3 times the upper limit of normal; serum creatinine >2 times the upper limit of normal at screening). (12) History of significant alcohol or substance abuse. (13) Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study. (14) Individuals with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. (15) Known hypersensitivity to the investigational medicinal products. (16) Participation in another clinical trial with investigational products within 3 months prior to screening. (17) Individuals with chronic diseases (e.g., uncontrolled hypertension or diabetes) that are not adequately managed and may pose a life-threatening risk, require hospitalization, cause severe physical disability, or significantly interfere with daily functioning. (18) Any other condition deemed by the principal investigator or sub-investigator to render the individual unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Dyspepsia Symptom Scale;Adequate relief for dyspepsia;Overall Treatment Effect;Dyspepsia visual analogue scale;Functional Dyspepsia-related Quality of Life (Assessment of Quality of Life in Patients with Functional Dyspepsia);Spleen qi deficiency questionnaire (Assessment of digestive weakness);Stomach qi deficiency questionnaire (Assessment of of gastrointestinal dysfunction);Food stagnation questionnaire (Assessment of symptoms due to food stagnation);Cold-heat questionnaire (Assessment of cold-heat pattern);Deficiency-excess questionnaire (Assess whether the condition is deficiency or excess);liver and renal function test;Incidence of adverse reaction;Vital signs (blood pressure, pulse, body temperature);Measurement of Korean medicine diagnostic devices (heart rate variability, tongue diagnosis, pulse diagnosis, and abdomen diagnosis);Intestinal and oral microbiome;Fecal metabolite profile;Blood metabolite profile | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Woo Park
Dongguk University Gyeongju Campus
Outcome results
None listed