Functional Dysphonia
Conditions
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.
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
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Korean version of the Gastrointestinal Symptom Rating Scale: Total score | From enrollment to the end of treatment at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for evaluating gastric mucosal improvement | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome. |
| Gastrointestinal symptom score | From enrollment to the end of treatment at 8 weeks | 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. |
| Patient's global assessment score | From enrollment to the end of treatment at 8 weeks | 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. |
| Pepsinogen I level (ng/mL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen | From enrollment to the end of treatment at 8 weeks | 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. |
| Pepsinogen I/Pepsinogen II ratio | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Gastrin-17 level (ng/L) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Helicobacter pylori IgG titer (units) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| High-sensitive C-reactive protein (mg/dL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
| Pepsinogen II level (ng/mL) | From enrollment to the end of treatment at 8 weeks | Measured at baseline and 8 weeks |
Countries
South Korea
Outcome results
None listed