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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
100
Artemisia and green tea extracts 700 mg/day for 8 weeks
Placebo 700 mg/day for 8 weeks
Pusan National University Yangsan Hospital
Yangsan, South Korea
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.
Time frame: From enrollment to the end of treatment at 8 weeks
The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Visual Analogue Scale for evaluating gastric mucosal improvement
Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.
Time frame: From enrollment to the end of treatment at 8 weeks
Gastrointestinal symptom score
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Patient's global assessment score
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.
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Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen I level (ng/mL)
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen II level (ng/mL)
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen I/Pepsinogen II ratio
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Gastrin-17 level (ng/L)
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Helicobacter pylori IgG titer (units)
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks
High-sensitive C-reactive protein (mg/dL)
Measured at baseline and 8 weeks
Time frame: From enrollment to the end of treatment at 8 weeks