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IRCT2016120323823N2 IRCT 2017-07-21 Shiraz University Of Medical Sciences and barijessence company Effect of rose oil soft gel on controlling the symptoms of ulcerative colitis Effect of rose oil soft gel on controlling the symptoms of ulcerative colitis in comparison to placebo: a randomized double blind placebo controlled trial 2017-07-23 anticipated 80 Complete https://irct.ir/trial/20268 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A ulcerative colitis. Intervention 1: 80 Samples select from target population that assign at least 40 patients to each of two treatment arms.Patients in interventional group receive rose oil soft gel, two capsule three times. oral, daily, for two months. Intervention 2: Patients in control group receive placebo(Sesame Oil soft gel) two capsule three times,oral. daily for two months.
public dr.Ali Tavakoli
Zand Street
Shiraz Iran (Islamic Republic of) +98 71 3233 1028 tavakkolia@sums.ac.ir Shiraz University Of Mdical Sciences scientific dr.Mehdi Pasalar
Zand Street
Shiraz Iran (Islamic Republic of) +98 71 3233 7589 pasalar@sums.ac.ir Shiraz University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with ulcerative colitis that previously confirmed with colonoscopy ;age> 18-70 years. exclusion criteria: history of steroid use in the past 4 weeks; history of any NSAIDs use in one week before; history of antibiotic use within 2 weeks before entering the study; any medicinal plants within 2 weeks before entering the study. 18 years 70 years Both K51 Ulcerative colitis Treatment - Drugs Treatment - Drugs 80 Samples select from target population that assign at least 40 patients to each of two treatment arms.Patients in interventional group receive rose oil soft gel, two capsule three times. oral, daily, for two months. Patients in control group receive placebo(Sesame Oil soft gel) two capsule three times,oral. daily for two months. Clinical symptoms. Timepoint: in at first visit and then weekly during 2 months of treatment. Method of measurement: mayo clinic-6 standard form. Quality of life. Timepoint: in at the beginning of the study and after 2 months of treatment. Method of measurement: IBDQ-9(Farsi version). CRP test. Timepoint: Before the intervention and end of the intervention(2 months). Method of measurement: Device. Fecal calprotectin. Timepoint: Before the intervention and end of the intervention(2 months). Method of measurement: stool exam. Side effect. Timepoint: daily. Method of measurement: drug side effect registration questionnaire. Shiraz University Of Medical Sciences and barijessence company Approved 2016-03-06 Shiraz University Of Medical Sciences Zand Strret Shiraz Iran (Islamic Republic of)