Clinical trial NCT06628804: Artemisia and Green Tea Extracts for Gastric Mucosal Health
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Functional Dysphonia
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The Korean version of the Gastrointestinal Symptom Rating Scale: Total score
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Visual Analogue Scale for evaluating gastric mucosal improvement
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Gastrointestinal symptom score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Patient's global assessment score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pepsinogen I level (ng/mL)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pepsinogen II level (ng/mL)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pepsinogen I/Pepsinogen II ratio
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Gastrin-17 level (ng/L)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Helicobacter pylori IgG titer (units)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: High-sensitive C-reactive protein (mg/dL)
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: