Effect of rose oil soft gel on controlling the symptoms of ulcerative colitis in comparison to placebo: a randomized double blind placebo controlled trial

Purpose : In this study, we compare rose oil soft gel with placebo in controlling the clinical symptoms of ulcerative colitis. Design of study and performance: This study is a randomized double blind placebo controlled trial in one center (Motahari Clinic)that perform On patients with ulcerative colitis that previously confirmed with colonoscopy , age> 18-70 years and at present have mild to moderate disease based on mayo clinic score. The main exclusion criteria are history of steroid use in the past 4 weeks, any NSAIDs in one week before, and the history of antibiotic use and any medicinal plants within 2 weeks before entering the study. 80 Samples select from target population that randomly assign at least 40 patients to each of two treatment arms. Patients randomly assign to receive either placebo(Sesame Oil soft gel) or rose oil soft gel, two capsule three times daily for two months with routine medications. Patients will be followed for 2 months. Patients will be visited 3 times, one at arrival and 2 times at the end of each month. Clinical symptoms and quality of life the patients will be evaluate with mayoclinic-6 standard form and IBDQ-9(Farsi version). The mayo clinic-6 standard form will be filled in at first visit and then weekly during 2 months of treatment by the patient, and IBDQ-9 will be filled in at the beginning of the study and after 2 months of treatment by the therapist. The CRP will be tested at beginning and end of the study. The primary outcome is control of clinical symptoms. possible side effects of medications will also record in the drug side effect registration questionnaire.

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