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Completed

NCT Number: NCT06628804

Artemisia and Green Tea Extracts for Gastric Mucosal Health

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?

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Key information

Conditions

Functional Dysphonia

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artemisia and green tea extracts

Dietary Supplement

Artemisia and green tea extracts 700 mg/day for 8 weeks

Placebo

Dietary Supplement

Placebo 700 mg/day for 8 weeks

Primary outcomes

  1. 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

  1. The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen

    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 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.

  2. Visual Analogue Scale for evaluating gastric mucosal improvement

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

    Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.

  3. Gastrointestinal symptom score

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

    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.

  4. Patient's global assessment score

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

    Measured at baseline and 8 weeks. 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.

  5. Pepsinogen I level (ng/mL)

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

    Measured at baseline and 8 weeks

  6. Pepsinogen II level (ng/mL)

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

    Measured at baseline and 8 weeks

  7. Pepsinogen I/Pepsinogen II ratio

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

    Measured at baseline and 8 weeks

  8. Gastrin-17 level (ng/L)

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

    Measured at baseline and 8 weeks

  9. Helicobacter pylori IgG titer (units)

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

    Measured at baseline and 8 weeks

  10. High-sensitive C-reactive protein (mg/dL)

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

    Measured at baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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