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IRCT2016102620071N2 IRCT 2017-01-22 Vice Chancellor for Research, Kermanshah University of Medical Sciences Evaluation the efficacy of Achillea wilhelmsii capsule in ulcerative colitis patients Evaluation the efficacy of Achillea wilhelmsii capsule in ulcerative colitis patients:a randomized double blind placebo controlled clinical trial 2016-11-25 anticipated 44 Complete https://irct.ir/trial/17819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is performed using blocking method. N/A ulcerative colitis. Intervention 1: Two capsules (each capsule contains 250 mg Achillea wilhelmsii) daily for a month, from Kermnanshah apothecary. Intervention 2: Two capsules (each capsule contains 250 mg hydroxypropyl methylcellulose from Sigma company) daily for a month.
public Mahtab Amiri
Faculty of pharmacy, Kermanshah University of Medical Sciences
kermanshah Iran (Islamic Republic of) +98 83 3725 3516 mahtaba942rocketmail.com Faculty of pharmacy, Kermanshah University of Medical Sciences scientific Mohamad hosein Farzaee
Faculty of pharmacy, Kermanshah University of Medical Sciences
kermanshah Iran (Islamic Republic of) +98 83 3426 6780 mh-farzaee@razi.tums.ac.ir Kermanshah university of medical sciences Iran (Islamic Republic of) Inclusion criteria:age>18- ability to swallow the capsule- patients who sign the testimonials and cooperate during the study.(In cases which patients do not have education,the investigator should read the testimonial for them.if they are satisfied, the investigator can include them to the study.)- patients who are not cured with Achillea wilhelmsii during a last month.-Patients who their diseases are approved by complete medical evaluation, colonoscopy, pathology and laboratory data.-Only patients with mild to moderate ulcerative colitis can be include to this study. Exclusion criteria:smokers-pregnant patients and nursing mothers-patients who have to use other drugs that interference with this medication (such as systemic NSAID, antihistamins or systemic antibiotics during last 2 weeks)- patients who are suffering from other diseases in addition to ulcerative colitis that the etiology of them are oxidative stress, such as metabolic syndrome, diabetic leg ulcer, coronary arterial disease, pulmonary infection, patients who are disposed to a serious health danger, such as severe cardiac, liver or renal diseases.- If significant side effects occur, the patient will be excluded from the study and followed to end of the study.- If a patient do not want to continue to cooperating for any reasons, he will be excluded from the study.- patients with severe allergy to this plant (dermatitis contact) will be excluded. 18 years 65 years Both k51.9 Ulcerative colitis, unspecified Treatment - Drugs Placebo Two capsules (each capsule contains 250 mg Achillea wilhelmsii) daily for a month, from Kermnanshah apothecary Two capsules (each capsule contains 250 mg hydroxypropyl methylcellulose from Sigma company) daily for a month Number of excretion daily. Timepoint: before using the drug-2 weeks after using the drug-30 days after using the drugs. Method of measurement: based on Mayo clinic questionary and ESR,CBC,CRP. Rate of rectal bleeding. Timepoint: before using the drug-2 weeks after using the drug-30 days after using the drugs. Method of measurement: based on Mayo clinic score, CRP, CBC, and ESR. Photo sensitivity- gastrointestinal disorders. Timepoint: Two weeks after using the drug- 30 days after using the drug. Method of measurement: based on side effect questionary. Vice Chancellor for Research, Kermanshah University of Medical Sciences Approved 2016-10-19 Ethics committee of Kermanshah University of Medical Sciences Kermanshah university of medical sciences Kermanshah Iran (Islamic Republic of)