None listed
Conditions
Interventions
Drug : Oral administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for 8 weeks
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) adults aged 19-75 years at the screening visit (2) according to Rome IV criteria, one or more of postprandial fullness, early satiety, epigastric pain, and epigastric heartburn without organic findings occurred at least 6 months ago and the symptoms persist for the last 3 months or more (3) the intensity of dyspepsia measured by 0-100mm visual analog scale is 40 points or more (4) those who have pledged not to receive any other new treatment for dyspepsia during the trial period (5) those who have voluntarily signed written informed consent approved by the institutional review board, after sufficient explanation of this studyt
Exclusion criteria
Exclusion criteria: (1) those who have been diagnosed with organic diseases such as peptic ulcer, esophageal cancer, MALT lymph cancer, stomach cancer, colon cancer, biliary tract and pancreatic disease (except asymptomatic cholelithiasis), inflammatory bowel disease, etc. within 1 year prior to screening (2) when the symptoms of reflux esophagitis and irritable bowel syndrome are more severe than those of dyspepsia (3) in case of severe weight loss, bloody stool, dysphagia, swallowing pain, persistent vomiting, and other alarm symptoms (4) those who have a significant neurological or psychological history or are currently suffering from major depressive disorder, anxiety disorder, schizophrenia, anorexia, epilepsy, etc. (5) those who have serious organic diseases (e.g., heart failure, angina pectoris, myocardial infarction, arrhythmia, valvular disease, malignancy, stroke, etc.) (6) those with a history of gastrointestinal surgery (in the case of appendectomy, if 6 months have passed since surgery, they can participate in clinical trials) (7) taking proton pump inhibitors, histamine receptor antagonists, antacids, prokinetics, fundus relaxants, mucosal protecting agents, anticholinergics, adsorbents, anti-bloating agents, antiemetics, emetics, gastrin receptor antagonists, and prostaglandin analogs or receiving Helicobacter eradication treatment that can affect the gastrointestinal tract within 2 weeks prior to screening (8) those who have received Korean medicine treatments such as acupuncture, herbal medicine, or moxibustion for the purpose of improving dyspepsia within 2 weeks prior to screening, or who are planning to receive treatment during the study period (9) those who have taken antibiotics within 3 months prior to screening (10) those who have taken lactic acid bacteria preparations within 1 month prior to screening (However, if the lactic acid bacteria have been taken continuously since 1 month prior to screening and the use and dose are not to be changed during the clinical trial period, clinical trial participation is possible) (11) severe liver or renal disease (aspartate aminotransferase or alanine aminotransferase levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal) (12) participants with a history of alcohol abuse or drug abuse within the past year (13) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial (14) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (15) participants with known hypersensitivity to investigational products (16) participants who had taken other investigational products within 3 months (17) those with chronic diseases that are not well controlled despite appropriate treatment (if there is a threat to life due to high blood pressure, diabetes, etc., hospitalization is required, serious physical disability is caused, or daily life is disrupted) (18) participants who are judged to be inappropriate for participating this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Dyspepsia Symptom Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Adequate relief for dyspepsia;Overall Treatment Effect;Dyspepsia visual analogue scale;Functional Dyspepsia-related Quality of Life;Gastrointestinal Symptom Score;Spleen qi deficiency questionnaire;Stomach qi deficiency questionnaire;Food stagnation questionnaire;Cold-heat questionnaire;Deficiency-excess questionnaire;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;single nucleotide polymorphism;Ultrasound gastric-duodenal motor function measurement (Kyung Hee University Korean medicine hospital at Gangdong only) | — |
Countries
Korea, Republic of
Contacts
Public ContactBoram Lee
Korea Institute of Oriental Medicine
Outcome results
None listed