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IRCT20210425051077N1 IRCT 2021-09-12 Vice Chancellor for Research of Khalkhal University of Medical Sciences Effect of curcumin supplementation in patients with lupus Effect of curcumin supplementation on disease activity, inflammatory factors and oxidative stress in patients with Systemic Lupus Erythematosus 2021-07-23 anticipated 66 Complete https://irct.ir/trial/55929 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Systemic lupus erythematosus. Intervention 1: Intervention group: curcumin group will receive two 500 mg curcumin capsules (Karen Co.) daily for 10 weeks. Intervention 2: Control group: control group will receive two placebo capsules (Karen Co.) daily for 10 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Elahe Mohammadi
Mozaffar Azizi
Khalkhal Iran (Islamic Republic of) ۵۶۸۱۷۶۱۳۵۱ +98 45 3243 2002 E.mohamadi52@yahoo.com Khalkhal University of Medical Sciences scientific Elahe Mohammadi
Mozaffar Azizi
Khalkhal Iran (Islamic Republic of) ۵۶۸۱۷۶۱۳۵۱ +98 45 3243 2002 E.mohamadi52@yahoo.com Khalkhal University of Medical Sciences Iran (Islamic Republic of) Not using any nutritional supplements within 2 months before the beginning of the study except calcium-vitamin D supplement No history of gallstones Not following a special diet Not using anticoagulant drugs Not having Coronavirus Disease Age between 18 and 60 years old 18 years 60 years Both 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 Having Coronavirus Disease M32.9 Systemic lupus erythematosus (SLE) Treatment - Drugs Placebo Intervention group: curcumin group will receive two 500 mg curcumin capsules (Karen Co.) daily for 10 weeks Control group: control group will receive two placebo capsules (Karen Co.) daily for 10 weeks High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Westergren method. C3 complement. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. C4 complement. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. Total Complement. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. Anti double stranded DNA antibody. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: ELISA kit. Interleukin-6. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: ELISA kit. Malondialdehyde. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. Total antioxidant capacity. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. Protein carbonyl. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: ELISA kit. Disease activity. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Systemic Lupus Erythematosus Disease Activity Index 2000 Questionnaire. Nitric oxide. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: Standard kit. 8-isoprostane. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: ELISA kit. Matrix metalloproteinase 9. Timepoint: At the beginning of the study and after 10 weeks intervention. Method of measurement: ELISA kit. Vice Chancellor for Research of Khalkhal University of Medical Sciences Approved 2021-07-15 Ethics committee of Khalkhal University of Medical Sciences Khalkhal University of Medical Sciences., Mozaffar Azizi St Khalkhal Ardabil Iran (Islamic Republic of)