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CompletedNCT06628804Updated Jan 13, 2026

Artemisia and Green Tea Extracts for Gastric Mucosal Health

An interventional study of Artemisia and green tea extracts and Placebo in Functional Dysphonia, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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?
Read the 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.
02

Conditions studied

  • Functional Dysphonia
03

In context

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Rome IV-based functional dyspepsia-

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Artemisia and green tea extracts group

    This group takes Artemisia and green tea extracts for 8 weeks.

    Dietary Supplement: Artemisia and green tea extracts

  • Placebo comparator
    Placebo group

    This group takes a placebo for 8 weeks.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementArtemisia and green tea extracts

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

  • Dietary supplementPlacebo

    Placebo 700 mg/day for 8 weeks

06

What researchers measure

Primary outcomes

  1. The Korean version of the Gastrointestinal Symptom Rating Scale: Total score

    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.

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

Secondary outcomes

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

    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.

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

  2. Visual Analogue Scale for evaluating gastric mucosal improvement

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

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

  3. Gastrointestinal symptom score

    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.

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

  4. Patient's global assessment score

    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.

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

  5. Pepsinogen I level (ng/mL)

    Measured at baseline and 8 weeks

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

  6. Pepsinogen II level (ng/mL)

    Measured at baseline and 8 weeks

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

  7. Pepsinogen I/Pepsinogen II ratio

    Measured at baseline and 8 weeks

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

  8. Gastrin-17 level (ng/L)

    Measured at baseline and 8 weeks

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

  9. Helicobacter pylori IgG titer (units)

    Measured at baseline and 8 weeks

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

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

    Measured at baseline and 8 weeks

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

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, 50612, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06628804
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sang Yeoup Lee (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Oct 8, 2024
Start date
Aug 1, 2024
Primary completion
Dec 30, 2025
Completion
Dec 31, 2025
Last update
Jan 13, 2026

Study contacts

Sang Yeoup Lee, MD,PhD
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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