NCT06628804已完成不适用
Effects of Artemisia and Green Tea Extracts on Promoting Gastric Mucosal Health in Adults With Functional Dyspepsia: A Randomized, Double-blind, Placebo-controlled Clinical Trial
适应症
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 Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety.
The main questions are:
- Does Artemisia and green tea extracts promote gastric mucosal health in participants?
- What side effects occur when participants take Artemisia and green tea extracts?
详细描述
Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.
Participants will:
- Take Artemisia and green tea extracts or a placebo daily for 8 weeks.
- Visit the clinic every 4 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 65 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.
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
- The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen(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)
- Gastrointestinal symptom score(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 I level (ng/mL)(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)
- Pepsinogen I/Pepsinogen II ratio(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)
- Helicobacter pylori IgG titer (units)(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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