Efficacy of Nigella sativa seed oil in treatment of functional dyspepsia

INTERVENTION: Intervention 1: Intervention group: 5 ml herbal drug (Mixture of Nigella sativa oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week. Intervention 2: Placebo group: 5 ml placebo (Mixture of mineral oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week. Intervention group: 5 ml herbal drug (Mixture of Nigella sativa oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week Placebo Placebo group: 5 ml placebo (Mixture of mineral oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week Treatment ‐ Drugs CONDITION: Diseases of the digestive system. ; Dyspepsia Dyspepsia PRIMARY OUTCOME: 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: 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). 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. INCLUSION CRITERIA: 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.