None listed
Conditions
Interventions
Drug : Oral administration of Yukgunja-tang or Pyeongwi-san, or usual care for 6 weeks
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
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 analogue scale is 40 points or more (4) those who have voluntarily signed written informed consent approved by the institutional review board, after sufficient explanation of this study
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 been diagnosed with mental disorders such as major depressive disorder, anxiety disorder, panic disorder, or have a depression score of 11 or higher on the Hospital Anxiety and Depression Scale (5) those who have a serious structural disease (e.g., heart, lung, liver, kidney disease, malignant disease) (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, antidepressants, fundus relaxant, mucosal protecting agents, nonsteroidal anti-inflammatory drugs, aspirin, anticholinergic drugs, or oral steroids or receiving Helicobacter eradication treatment that can affect the gastrointestinal tract within 2 weeks prior to screening (however, taking low-dose aspirin (100 mg/day or less) for the purpose of preventing cardiovascular disease is allowed) (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) 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) (10) participants with a history of alcohol abuse or drug abuse within the past year (11) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial (12) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (13) participants with known hypersensitivity to investigational products (14) participants who had taken other investigational products within 3 months (15) 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 |
|---|---|
| Single Dyspepsia Symptom Scale;Overall Treatment Effect;Dyspepsia visual analogue scale;Functional Dyspepsia-related Quality of Life;hospital anxiety and depression scale;health-related quality of life (EQ-5D-5L);Spleen qi deficiency questionnaire;Damum questionnaire;serum ghrelin level (acyl-ghrelin, deacyl-ghrelin, Ratio of acyl-ghrelin to total ghrelin);liver and renal function, CBC and electrolyte test;Incidence of adverse reaction;Cost investigation | — |
Countries
Korea, Republic of
Contacts
Public ContactBoram Lee
Korea Institute of Oriental Medicine
Outcome results
None listed