Meu-cinn for Gastric Mucosal Health in Adults With Functional Dyspepsia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorPusan National University Yangsan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Meu-cinn

    Dietary supplement

    Meu-cinn 250 mg/day for 8 weeks

  • Placebo

    Dietary supplement

    Placebo 250 mg/day for 8 weeks

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Meu-cinn groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks
2

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

Time frame
From enrollment to the end of treatment at 8 weeks
3

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.

Time frame
From enrollment to the end of treatment at 8 weeks
4

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

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