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IRCT20180207038664N1 IRCT 2018-04-30 Ahvaz University of Medical Sciences The effect of curcumin supplementation in the treatment of patients with ulcerative colitis The effect of curcumin supplementation on clinical Outcomes, and some Inflammatory Markers in Patients with Ulcerative Colitis 2018-02-19 anticipated 70 Complete https://irct.ir/trial/29599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be done by simple method. The unit of randomization is individual. Using a random number table, a number is considered for each patient, respectively.To the number 0-4, box A and to the number 5-9, box B delivered by an individual except the researcher.So that the person providing the treatment is unaware, Blinding description: The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant capsules are coded A and B by an individual except the researcher, in order to blind the researcher about which supplement each group received. When delivering supplements to patients, some one except the researcher should locate the patient in either A or B group by random number table. In this study, the patient, physician and researcher (who collecting data, assessing the outcome and analyzing the data) should be kept blind. 3 Ulcerative colitis. Intervention 1: Intervention group:Curcumin supplement, 1500 milligram daily, 3 times per day ,500 milligram capsule each time, for 60 days. Karen Pharma & Food Supplement Co. Intervention 2: Control group: Placebo, Starch and edible color, 3 times per day ,500 milligram capsule each time, for 60 days. Karen Pharma & Food Supplement Co. Yes - There is a plan to make this available What will be shared: If the decision is to publicate the data, after the unidentified individuals all data will be publicated. When: The access period will be 6 months after the publication of the results. To whom: Researchers working in academic and industrial institutions can apply to get data. Conditions: To cite. Referring to reference or researcher's permission Where to obtain: Narges Sadeghi Faculty of Paramedicine, jundishapur University of Medical Sciences, golestan Blvd, Ahvaz. 06133214578 sadeghi.n@ajums.ac.ir How to obtain: Access to articles related to this research Send email to the responsible author Comments:
public Narges Sadeghi
Faculty of Paramedicine, jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 sadeghi.n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Anahita Mansoori
Paramedical School,Ahvaz Jundishapur University of Medical Sceinces, Golestan Blvd, Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3336 7543 mansoori_anahita@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Ulcerative colitis, confirmed by histopathology The severity of the disease is mild to moderate Patients without current diagnosis of other inflammatory, autoimmune and inclusive disease( including cancer, kidney disease, rheumatoid arthritis, liver disease, AIDS, and cardiovascular disease) The age range is between 17-70 years Tendency to participate in the study No changes in the type and amount of drug in the past month The patient should not be pregnant or breastfeeding 17 years 70 years Both The patient is in the acute phase of the disease Reluctance to continue cooperation in this research History of large gastrointestinal surgery (except appendectomy, Cholecystectomy and hemorrhoidectomy) Smoking, alcohol and drug abuse Patients with gallstones or any disorder of the gallbladder, bladder stones K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group:Curcumin supplement, 1500 milligram daily, 3 times per day ,500 milligram capsule each time, for 60 days. Karen Pharma & Food Supplement Co. Control group: Placebo, Starch and edible color, 3 times per day ,500 milligram capsule each time, for 60 days. Karen Pharma & Food Supplement Co. Serum hs-CRP. Timepoint: The beginning of the study- The end of the study. Method of measurement: ELISA. Serum TNF-a. Timepoint: The beginning of the study- The end of the study. Method of measurement: ELISA. Serum ESR. Timepoint: The beginning of the study- The end of the study. Method of measurement: Westergren's Method. Stool frequency per day. Timepoint: The beginning of the study- The end of the study. Method of measurement: Mayo Score. Frequency of rectal bleeding per day. Timepoint: The beginning of the study- The end of the study. Method of measurement: Mayo Score. Ahvaz University of Medical Sciences Approved 2018-01-20 Ethics committee of Ahvaz University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)