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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:
Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artemisia and green tea extracts group | Experimental | This group takes Artemisia and green tea extracts for 8 weeks. |
|
| Placebo group | Placebo Comparator | This group takes a placebo for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemisia and green tea extracts | Dietary Supplement | Artemisia and green tea extracts 700 mg/day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD,PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
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| Placebo | Dietary Supplement | Placebo 700 mg/day for 8 weeks |
|
| 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. | 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. | 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. | From enrollment to the end of treatment at 8 weeks |
| Pepsinogen I level (ng/mL) | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |
| Pepsinogen II level (ng/mL) | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |
| Pepsinogen I/Pepsinogen II ratio | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |
| Gastrin-17 level (ng/L) | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |
| Helicobacter pylori IgG titer (units) | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |
| High-sensitive C-reactive protein (mg/dL) | Measured at baseline and 8 weeks | From enrollment to the end of treatment at 8 weeks |