Artemisia and Green Tea Extracts for Gastric Mucosal Health

NCT ID: NCT06628804

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

Functional Dysphonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Artemisia and green tea extracts group

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

Group Type: EXPERIMENTAL

Artemisia and green tea extracts

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

This group takes a placebo for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo 700 mg/day for 8 weeks

Interventions

Artemisia and green tea extracts

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo 700 mg/day for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

12-2024-006

Identifier Type: -

Identifier Source: org_study_id