Functioanl Dyspepsia
Conditions
Brief summary
This clinical trial aims to determine whether Meu-cinn promotes gastric mucosal health in adults with functional dyspepsia and to assess its safety. The main questions are: * Does Meu-cinn promote gastric mucosal health in participants? * What side effects occur when participants take Meu-cinn?
Detailed description
Researchers will compare Meu-cinn to placebo to evaluate their effectiveness in promoting gastric mucosal health. Participants will: * Take Meu-cinn or a placebo daily for 8 weeks. * Visit the clinic at 1, 2, 4, and 8 weeks for checkups and tests.
Interventions
DIETARY_SUPPLEMENTMeu-cinn
Meu-cinn 250 mg/day for 8 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo 250 mg/day for 8 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Rome IV-based functional dyspepsia-
Exclusion criteria
* Patients with gastrointestinal symptoms requiring immediate drug treatment. * Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome. * Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial. * Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month. * Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year. * Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy. * Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg). * Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL). * Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution. * Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution. * Alcohol abusers. * Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders). * Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period. * Individuals with allergies to any components of the study foods. * Individuals who participated in or plan to participate in another drug clinical trial within the last month. * Individuals deemed unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Korean version of the Gastrointestinal Symptom Rating Scale, Total score | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 15 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 45, and higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen | From enrollment to the end of treatment at 8 weeks | Measure at baseline, 1, 2, 4, and 8 weeks. This is a 4-point Likert scale for each of the 8 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 21, and higher scores mean a worse outcome. |
| Patient's global assessment score | From enrollment to the end of treatment at 8 weeks | The 5-point Likert scale for the Patient's Global Assessment Score is a self-reported tool where patients rate their disease activity. It uses an order scale, with 5 indicating "Very Good" and 1 indicating "Poor." The patient evaluates their condition based on this scale: Very Good-Good-Fair-Unchanged-Poor |
| Visual Analogue Scale for evaluating gastric mucosal improvement | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome. |
| Gastrointestinal symptom score | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome. For each gastrointestinal symptom, the minimum value was 0, and the maximum value was 4, and higher scores mean a worse outcome. |
| Pepsinogen I level (ng/mL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Pepsinogen II level (ng/mL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Pepsinogen I/Pepsinogen II ratio | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Gastrin-17 level (ng/L) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| High-sensitive C-reactive protein (mg/dL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Immunuglobulin G (mg/dL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Immunoglobulin A (mg/dL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Immunoglobulin M (mg/dL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| The derivatives of reactive oxidative metabolites (CARR U) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Biological antioxidant potential (u M) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSang Yeoup Lee, Professor, MD, PhD
Pusan National University Yangsan Hospital
Outcome results
None listed