A randomized placebo-controlled study: The effect of Siang Pure Oil in patients with functional dyspepsia
Phase 2
- Conditions
- Functional dyspepsiaDyspepsia
- Registration Number
- TCTR20230418004
- Lead Sponsor
- Bertram (1958) co. ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. age 18-80 years
2. diagnosed with functional dyspepsia based on ROME IV criteria with mild to very Severe Symptoms evaluated by Gastrointestinal Overall Symptom (GOS) Scale within 28 days prior to enrollment
3. symptom of abdominal bloating with specific symptom GOS Scale of at least 2 points within 28 days prior to enrollment
4. history of normal upper endoscopy within 5 years before enrollment
Exclusion Criteria
1.adjustment of continuous dyspepsia medications within 1 month prior to enrollment
2.presence of H.pylori infection or eradication less than 3 months prior to enrollment
3.pregnant or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with self-reported satisfaction at 28 days 28 days of treatment patients with over 50% satisfaction in 28 days,GOS improvement (GOS28) 28 days of treatment GOS (total, specific symptoms)
- Secondary Outcome Measures
Name Time Method Percentage of patients with self-reported satisfaction at 2 days 2 days of treatment patients with over 50% satisfaction in 2 days,Percentage of patients with self-reported satisfaction at 14 days 14 days of treatment patients with over 50% satisfaction in 14 days,GOS improvement (GOS2) 2 days of treatment GOS (total, specific symptoms),GOS improvement (GOS14) 14 days of treatment GOS (total, specific symptoms),Quality of life 28 days of treatment SF-NDI,Adverse effects 28 days of treatment Adverse effects reported by patients