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IRCT20190129042552N1 IRCT 2019-06-21 Ahvaz University of Medical Sciences Evaluation of the effect of ginger supplementation on clinical outcomes, serum levels of some inflammatory markers, TAC and expression of mir-21 in patients with active ulcerative colitis ---- Evaluation of the effect of ginger supplementation on clinical outcomes, serum levels of some inflammatory markers(TNF-α, hs-CRP) , TAC and expression of mir-21 in patients with active ulcerative colitis 2019-06-22 anticipated 44 Complete https://irct.ir/trial/38928 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: ------, 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. Odd or even numbers will be allocated to the A or B group. To achieve allocation concealment, the bottles will be sealed and we will be assured from the similarity of appearance and their weight. The randomization process will be performed by an individual other than the investigators to reduce the probable bias, Blinding description: Ginger and placebo capsules (in identical appearance container) are encoded by someone other than researcher. N/A Ulcerative colitis. Intervention 1: Intervention group: ginger supplementation 3 grams per day for 3 months. Intervention 2: Control group: placebo supplementation 3 grams daily for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is ---
public Forough shayesteh
Golestan Blvd
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3333 3477 Forough_shayesteh@yahoo.com Ahvaz University of Medical Sciences scientific Fatemeh haidari
Golestan
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3333 3477 haidari58@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Moderate to sever active ulcerative colitis patients Absence of fulminant colitis Male and female aged 18 to 50 years Body mass index 18/5 - 30 Lack of other digestive disorders and uncontrolled disease Lack of sensitivity to ginger 18 years 50 years Both Use of anti TNF-α Pregnancy Menopause Use of anti-coagulants, anti-diabetic and anti-blood pressure medication K51 Ulcerative colitis Other Other Intervention group: ginger supplementation 3 grams per day for 3 months Control group: placebo supplementation 3 grams daily for 3 months Clinical score. Timepoint: Before and after intervention. Method of measurement: Partial mayo score. Serum level of mir-21. Timepoint: Before and after intervention. Method of measurement: PCR. Serum level of TNF-a. Timepoint: Before and after intervention. Method of measurement: Elisa kit. Serum level of hs-CRP. Timepoint: Before and after intervention. Method of measurement: Elisa kit. Total antioxidant capacity. Timepoint: Before and after intervention. Method of measurement: Elisa kit. Ahvaz University of Medical Sciences Approved 2019-02-23 Ethics commitee of Ahvaz university of medical sciences Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)