NCT06628804CompletedNot Applicable
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
Pusan National University Yangsan Hospital1 site in 1 country100 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The Korean version of the Gastrointestinal Symptom Rating Scale: Total score
Study Overview
Brief Summary
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?
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Artemisia and green tea extracts group
Experimental
This group takes Artemisia and green tea extracts for 8 weeks.
Intervention: Artemisia and green tea extracts (Dietary Supplement)
Placebo group
Placebo Comparator
This group takes a placebo for 8 weeks.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
The Korean version of the Gastrointestinal Symptom Rating Scale: Total score
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital
Study Sites (1)
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