Artemisia and Green Tea Extracts for Gastric Mucosal Health

NCT06628804 | Completed

• 1 other identifier: 12-2024-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Functional Dysphonia

Outcome Measures

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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (10)

• 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

Study Arms (2)

Artemisia and green tea extracts group

EXPERIMENTAL

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

Dietary Supplement: Artemisia and green tea extracts

Placebo group

PLACEBO COMPARATOR

This group takes a placebo for 8 weeks.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo 700 mg/day for 8 weeks

Placebo group

Artemisia and green tea extracts DIETARY_SUPPLEMENT

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

Artemisia and green tea extracts group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV-based functional dyspepsia-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD,PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

KR (1)