About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Rome IV-based functional dyspepsia-
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Meu-cinn
Dietary supplementMeu-cinn 250 mg/day for 8 weeks
Placebo
Dietary supplementPlacebo 250 mg/day for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
The Korean version of the Gastrointestinal Symptom Rating Scale, Total score
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 outcomes
The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen
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
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
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
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.
Sponsors and contacts
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