Effect of curcumin supplementation on disease activity, inflammatory factors and oxidative stress in patients with Systemic Lupus Erythematosus

Determining the effect of curcumin supplementation on disease activity, inflammatory factors and oxidative stress in patients with SLE

Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Clinical Trial on 66 patients. A Randomized block design and random allocation software (RAS) will be used for randomization.

The present study will be conducted on 66 patients with Systemic lupus erythematosus from Sayad Shirazi Rheumatology Clinic in Gorgan. Subjects will be randomly allocated in curcumin and placebo groups. At the beginning of the study, each volunteer will complete a general questionnaire, disease activity questionnaire and a 3-day food record. Blood samples (10 cc) will be collected from each patient for measurement of study outcomes. Then curcumin group will receive two 500 mg curcumin capsules daily for 10 weeks and the placebo group will receive two placebo capsules daily for the same period. Evaluation of dietary intakes and blood sampling to measure biochemical parameters will be repeated at the end of the intervention period for both groups.

Inclusion criteria: age between 18 and 60 years old, no history of gallstones, not following a special diet, not using anticoagulant drugs Exclusion criteria: pregnancy and lactation, change in type and dose of drugs, following a special diet during the study, starting to take any dietary supplements during the study

The curcumin group will receive two 500 mg curcumin capsules daily for 10 weeks. The placebo group will receive two placebo capsules daily for 10 weeks.

High-sensitivity C-reactive protein, erythrocyte sedimentation rate, C3 complement, C4 complement, total complement, anti-double stranded DNA antibody, interleukin-6, malondialdehyde, total antioxidant capacity, protein carbonyl

Due to remaining serum samples, we decided to measure other variables to reach more comprehensive results.

Patients will be allocated in curcumin or placebo group using a randomized block design and the random allocation software (RAS,link:https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-4-26), with subjects matched in each block by sex, the category of medication (anti-malaria, corticosteroids and immunosuppressive drugs) and status of calcium-vitamin D intake (using or not using). To achieve blinding the volume of each block will be considered 4.

The supplement and placebo boxes will be coded by investigator as A and B. and then they will be distributed among the patients by one of the staff who had no clinical involvement in the study and information about the contents of the boxes.

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