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

Pusan National University Yangsan Hospital100 enrolled

Overview

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?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Functioanl Dyspepsia

Interventions

Meu-cinnDIETARY_SUPPLEMENT

Meu-cinn 250 mg/day for 8 weeks

PlaceboDIETARY_SUPPLEMENT

Placebo 250 mg/day for 8 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

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.

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

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.

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

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

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

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.

Central Contacts

Sang Yeoup Lee, Professor, MD, PhD

CONTACT

82+55-360-2860 drsaylee@gmail.com

Data from ClinicalTrials.gov

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