Effect of rose oil (Rosa damascena) softgel on cardinal manifestations of patients with gastro-esophageal reflux disease in comparison with omeprazole capsule, a double blind randomized controlled trial

The study is a randomized double blind controlled trial in which rose oil softgel is compared with omeprazole capsules on gastroesophageal reflux disease. The blinding is exerted for patients and researchers. Study population is the admitted outpatients to GI clinic of Rasoul Akram hospital. Each patient will be visited by a gastroenterologist and gastro-esophageal reflux disease (GERD) will be diagnosed clinically. Inclusion criteria include: Patients between 16 to 80 years old, patients have at least 12 weeks history of GERD, no inclusion of patients with peptic ulcer or its complications, no inclusion of patients taking antibiotics for H. pylori eradication during last 28 days. Exclusion criteria include: Appearance of drug adverse effects and loss of patient compliance. GERD patients fill the written consent form and conditions of the research will be explained. Then, the patients are randomly divided into two 35-patient groups: Group one: Rose oil softgel (two softgels TDS) + one placebo capsule (once daily). Group two: one 20 mg omeprazole capsule (once daily) + placebo softgel (two softgels TDS). Three visits are accomplished for each patient; First admission, 10 days later and 20 days later. The needed drug is rendered to the patients at the first admission for 10 days. At the 2nd visit, changes in the cardinal manifestations including heartburn and regurgitation will be evaluated. Then, the rest of drugs will be rendered. At the third visit changes will be evaluated again. Then, data gathering and analysis with SPSS will be done.

All funding comes from Barij Essence Pharmaceutical Company