Safety and Effectiveness of Bhutanese Traditional Herbal Drug Formulary for Gastritis-related Problems
Phase 2
- Conditions
- Gastritis-equivalent problemsGastritisTraditional MedicineDyspepsiaDrug-Related Side Effects and Adverse Reactions
- Registration Number
- TCTR20180430004
- Lead Sponsor
- Department of Traditional Medicine Services (DTMS), Bhutan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Adult age at least 18 years old
Gastritis-equivalent problems (wind energy and phlegm disorders)
Exclusion Criteria
Severe GI problems
Bile disorders མà½à¾²à½²à½¦à¼‹à½¤à½¦à¼‹à½†à½ºà¼‹à½–འི་à½à½‘པà¼
Allergy to the components of the medicine
Severe gastritis or peptic ulcer on upper gastrointestinal endoscopy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety / Adverse Drug Reaction (ADR) Week 1, 2, 3, 4 Naranjo's Algorithm
- Secondary Outcome Measures
Name Time Method Gastritis Symptoms Week 0, 1, 2, 3, 4 Severity of Dyspepsia Assessment (SODA)