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IRCT20101014004934N3 IRCT 2023-11-27 Kashan University of Medical Sciences Investigating the effect of curcumin in rheumatoid arthritis Investigation of the effect of curcumin supplementation on clinical status, inflammatory factors, oxidative stress biomarkers in patients with rheumatoid arthritis 2023-11-22 anticipated 60 Complete https://irct.ir/trial/72918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, initial sampling is done by the 'available' method from the rheumatology clinic of Beheshti Hospital among the patients who come for treatment. The way of randomization is that rheumatoid arthritis patients are placed in separate classes based on two criteria: BMI (BMI < 30 and BMI ≥ 30) and age (> 45 and ≤ 45) and then are randomly assigned to one of the two groups. Curcumin or placebo (containing starch) are added as supplements. Randomization is done using Stat Trek software and based on the random number table method, Blinding description: The patient and the attending physician are not aware of the fact that the patient is receiving a placebo or curcumin supplement. 3 Rheumatoid Arthritis. Intervention 1: The Intervention group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of 60 Rheumatoid arthritis patients randomly selected), who are supplemented with Curcumin produced by Dineh Pharmaceutical Company, with a dose of 500 mg, 1 daily for 12 weeks in addition to the standard treatment of Rheumatoid arthritis. Intervention 2: Control group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of sixty Rheumatoid arthritis patients randomly selected), who received a Placebo pill (Starch: containing 505 mg of Maltodextrin) with the appearance characteristics Same as 505 mg Curcumin supplement, 1 daily for 12 weeks in addition to standard treatment of Rheumatoid arthritis. 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 There is no further information
public Kamal Esalatmanesh
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715973447 +98 31 5500 9999 Kamalesalatmanesh@kaums.ac.ir Kashan University of Medical Sciences scientific Kamal Esalatmanesh
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715973447 +98 31 5500 9999 Kamalesalatmanesh@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with rheumatoid arthritis based on diagnostic criteria Age 20-70 years No smoking 20 years 70 years Both Reluctance to cooperate Hypothyroidism or hyperthyroidism Consumption of any type of supplement (vitamins, salts, etc.) by the patient during the last 3 months Having any acute and active infection M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo The Intervention group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of 60 Rheumatoid arthritis patients randomly selected), who are supplemented with Curcumin produced by Dineh Pharmaceutical Company, with a dose of 500 mg, 1 daily for 12 weeks in addition to the standard treatment of Rheumatoid arthritis. Control group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of sixty Rheumatoid arthritis patients randomly selected), who received a Placebo pill (Starch: containing 505 mg of Maltodextrin) with the appearance characteristics Same as 505 mg Curcumin supplement, 1 daily for 12 weeks in addition to standard treatment of Rheumatoid arthritis. Severity of clinical symptoms before and after treatment. Timepoint: Before the start of the intervention and twelve weeks later. Method of measurement: Based on Disease Activity Score 28 (DAS28) and Visual Analog Scale (VAS). Total plasma antioxidant. Timepoint: Before the start of the intervention and twelve weeks later. Method of measurement: Antioxidant capacity of plasma is determined by ELISA method. Plasma malondialdehyde. Timepoint: Before the start of the intervention and twelve weeks later. Method of measurement: Determination of malondialdehyde is done by ELISA method. Serum Hs-CRP. Timepoint: Before the start of the intervention and twelve weeks later. Method of measurement: Serum hs-CRP is performed using an ELISA device (immunoassay method). Kashan University of Medical Sciences Approved 2023-10-22 Ethics committee of Kashan University of Medical Sciences Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)