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Study aim
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Determining the effect of curcumin supplementation on clinical symptoms, inflammatory factors, oxidative stress biomarkers in Rheumatoid arthritis patients
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Design
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In this clinical trial (phase 3), two parallel, two-blind, randomized groups with two groups as Control and Intervention (30 people in each group) were first selected as available and then randomly selected in each group. They are selected based on body mass index and weight
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Settings and conduct
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This study was conducted in Rheumatoid arthritis patients referred to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan. In this study, patients in both Intervention and Control groups receive standard treatment. In the intervention group, Curcumin produced by Dinah Pharmaceutical Company, with a dose of 500 mg, 1 tablet daily for 12 weeks, in addition to standard treatment and in the control group Placebo is used in addition to standard treatment. Placebo and Curcumin are both in the same form, same weight and same packaging, which is written by the researcher on the back of the package, and the doctor and the patient do not know whether it is a drug or a placebo.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients with Rheumatoid arthritis based on diagnostic criteria
Age 20-70 years
No smoking.
Exclusion criteria:
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.
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Intervention groups
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Intervention group: Taking Curcumin alongside standard treatment
Control group: receiving a Placebo alongside the standard treatment
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Main outcome variables
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Severity of clinical symptoms before and after treatment based on Disease Activity Score 28 and Visual Analog Scale; plasma total antioxidant; plasma malondialdehyde; serum Hs-CRP