Meu-cinn for Gastric Mucosal Health in Adults With Functional Dyspepsia
NCT ID: NCT06630455
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-04
2025-12-31
Brief Summary
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The main questions are:
* Does Meu-cinn promote gastric mucosal health in participants?
* What side effects occur when participants take Meu-cinn?
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Meu-cinn group
This group takes Meu-cinn for 8 weeks.
Meu-cinn
Meu-cinn 250 mg/day for 8 weeks
Placebo group
This group takes placebo for 8 weeks.
Placebo
Placebo 250 mg/day for 8 weeks
Interventions
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Meu-cinn
Meu-cinn 250 mg/day for 8 weeks
Placebo
Placebo 250 mg/day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
19 Years
70 Years
ALL
Yes
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Sang Yeoup Lee
Professor
Principal Investigators
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Sang Yeoup Lee, Professor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12-2024-009
Identifier Type: -
Identifier Source: org_study_id
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