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IRCT20190916044787N1 IRCT 2019-10-01 Ahvaz University of Medical Sciences The effect of metformin on decreasing the severity of rheumatoid arthritis The effect of metformin on decreasing activity and severity of rheumatoid arthritis disease (pilot study) 2019-04-04 anticipated 60 Complete https://irct.ir/trial/42187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By random block permutation, individuals will be divided into two groups. The block sizes can be 4, 6 and so on. 6 blocks including 4 characters will be considered; AABB, ABAB, BBAA, BABA, ABBA, and BAAB. We will sample from the six blocks with replacement to the extent that the sample size is completed. In this case, a sequence of letters will be obtained, in which individuals will be randomly divided into two equal groups, Blinding description: All medications will be in similar and dark pockets. A numeric label will be on each pack of medications. Patient and researcher will not inform of the number assigned to the relevant group. Then, according to the random sequence based on random block permutation, the packets of medications will be given to the researcher. 3 Rheumatoid arthritis. Intervention 1: Intervention group: Metformin (Najo Company, Iran) is given at a dose of 500 mg twice a day for 12 weeks. Intervention 2: Control group: Placebo (made in School of Pharmacy, Ahvaz University of Medical Sciences) is given at a dose of 500 mg twice a day for 12 weeks. 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 No more information
public Sajedeh Igder
Imam Khomeini Hospital., Azadegan Ave
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2114 Drsajedehigder3393@gmail.com Ahvaz University of Medical Sciences scientific Karim Mowla
Jundishapur University of Medical Sciences, Golestan Bldv.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 Mowla_k@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with moderate to high severity of rheumatoid arthritis based on the DAS28 scale 18 years no limit Both Duration of illness over 3 years There is significant kidney disorder that forbids from using metformin (GFR <30) Pregnancy Significant heart failure (EF <50%) Chronic hepatic impairment or acute liver failure Having diabetes or previous and recent use of metformin The last 3 months of anti-inflammatory drugs New drug added to control patient symptoms during treatment M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo Intervention group: Metformin (Najo Company, Iran) is given at a dose of 500 mg twice a day for 12 weeks Control group: Placebo (made in School of Pharmacy, Ahvaz University of Medical Sciences) is given at a dose of 500 mg twice a day for 12 weeks. Disease severity. Timepoint: At baseline and after treatment (12 weeks). Method of measurement: DAS28. Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and after treatment (12 weeks). Method of measurement: Western Green analysis. Swollen joint count (SJC). Timepoint: At baseline and after treatment (12 weeks). Method of measurement: Examination and clinical judgment of the physician. Tender joint count (TJC). Timepoint: At baseline and after treatment (12 weeks). Method of measurement: Examination and clinical judgment of the physician. CRP. Timepoint: At baseline and after treatment (12 weeks). Method of measurement: Aagglutination test. Ahvaz University of Medical Sciences Approved 2018-09-22 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town Ahvaz Khouzestan Iran (Islamic Republic of)