Artemisia and Green Tea Extracts for Gastric Mucosal Health

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Functional Dysphonia

Treatments: Dietary Supplement: Artemisia and green tea extracts; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06628804

12-2024-006

Details and patient eligibility

About

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?

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Artemisia and green tea extracts group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Artemisia and green tea extracts

Placebo group

Placebo Comparator group

Description:

This group takes a placebo for 8 weeks.

Treatment:

Dietary Supplement: Placebo