NCT06630455已完成不适用
Effects of Meu-cinn on Promoting Gastric Mucosal Health in Adults With Functional Dyspepsia: A Randomized, Double-blind, Placebo-controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Korean version of the Gastrointestinal Symptom Rating Scale, Total score
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rome IV-based functional dyspepsia-
排除标准
- •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.
研究组 & 干预措施
Meu-cinn group
Experimental
This group takes Meu-cinn for 8 weeks.
干预措施: Meu-cinn (Dietary Supplement)
Placebo group
Placebo Comparator
This group takes placebo for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The Korean version of the Gastrointestinal Symptom Rating Scale, Total score
时间窗: 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.
次要结局
- Immunoglobulin M (mg/dL)(From enrollment to the end of treatment at 8 weeks)
- The derivatives of reactive oxidative metabolites (CARR U)(From enrollment to the end of treatment at 8 weeks)
- Biological antioxidant potential (u M)(From enrollment to the end of treatment at 8 weeks)
- Pepsinogen I/Pepsinogen II ratio(From enrollment to the end of treatment at 8 weeks)
- Visual Analogue Scale for evaluating gastric mucosal improvement(From enrollment to the end of treatment at 8 weeks)
- Gastrin-17 level (ng/L)(From enrollment to the end of treatment at 8 weeks)
- Immunuglobulin G (mg/dL)(From enrollment to the end of treatment at 8 weeks)
- Immunoglobulin A (mg/dL)(From enrollment to the end of treatment at 8 weeks)
- Gastrointestinal symptom score(From enrollment to the end of treatment at 8 weeks)
- Pepsinogen I level (ng/mL)(From enrollment to the end of treatment at 8 weeks)
- The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen(From enrollment to the end of treatment at 8 weeks)
- Patient's global assessment score(From enrollment to the end of treatment at 8 weeks)
- Pepsinogen II level (ng/mL)(From enrollment to the end of treatment at 8 weeks)
- High-sensitive C-reactive protein (mg/dL)(From enrollment to the end of treatment at 8 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital
研究点 (1)
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