Efficacy of Nigella sativa seed oil in treatment of functional dyspepsia
Phase 2
- Conditions
- Diseases of the digestive system.Dyspepsia
- Registration Number
- IRCT201505031157N11
- Lead Sponsor
- Vice chancellor for research, Institute of Medicinal Plants
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Patients with clinical diagnosis of functional dyspepsia. Exclusion criteria: Patients with organic causes of dyspepsia; peptic ulcer disease; inflammatory bowel disease; pure gastroesophageal reflux disease; incomplete or discontinuation of treatment functional dyspepsia; patients with a history of taking H. pylori eradicating medication in previous 3 months; any gastrointestinal surgery; clinical history of any underlying disease such as coronary heart disease, diabetes mellitus, asthma, cancer, and chronic obstructive pulmonary disease; taking medication such as antihypertensive drugs, corticosteroids and supplements such as iron and calcium.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional dyspepsia. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Functional dyspepsia was measured according to ROME III criteria and confirmed by upper gastrointestinal endoscopy.
- Secondary Outcome Measures
Name Time Method Helicobacter pylori infection. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Helicobacter pyloril infection was determined in laboratory by commercial urease test kit.;Health survey. Timepoint: At starting of the study and after 8 weeks. Method of measurement: Health survey was determined according to standared health survey short form (SF-36).