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IRCT20100408003664N24 IRCT 2020-01-06 Tabriz University of Medical Sciences The effects of curcumin supplementation in the treatment of rheumatoid arthritis disease Effects of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis 2019-12-08 anticipated 48 Complete https://irct.ir/trial/44564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 8 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to menopausal status ,age and BMI variables, Blinding description: The placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study. 2 rheumatoid arthritis. Intervention 1: Intervention group: 500 mg/day curcumin of karen company (1 capsule of 500 mg) after lunch for 2 month. Intervention 2: Control group: 500 mg/day placebo(1 capsule of 500mg containing starch flour) after lunch for 2 month. 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 Because the research project has not started yet.
public Fateme Pourhabibi
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 13 3360 5852 fatemephz1214@gmail.com Tabriz University of Medical Sciences scientific Fateme Pourhabibi
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 13 3360 5852 fatemephz1214@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The age range of 20-70 years in women Diagnosis of RA based on American College Rheumatology criteria and duration of more than one year Moderate RA (disease activity score 1.5-3.2) No infectious disease at least two weeks before study Body mass index less than 40 kilograms per square meters willingness to participate in the study. 20 years 70 years Female Pregnant or lactating women those under hormone therapy or use of oral contraceptives suffering from cardiovascular disease, liver and kidney failure and inflammatory disease, diabetes and hypertension use of lipid and glycemic lower drugs and anticoagulant drugs Changes in medications during the study use of curcumin supplements and any antioxidant supplements in the last 2 months and during the study weight loss diet smoking M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo Intervention group: 500 mg/day curcumin of karen company (1 capsule of 500 mg) after lunch for 2 month Control group: 500 mg/day placebo(1 capsule of 500mg containing starch flour) after lunch for 2 month Serum level of hs-CRP. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: ELISA. Disease Activity Score28. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Disease Activity Score 28 Questionnaire. Serum level of visfatin. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: ELISA. Serum level of ESR. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Westergren. Triglyceride. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Enzymatic method. Total cholesterol. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Enzymatic method. HDL-C. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Enzymatic method. LDL-C. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Freidewald formula. Fasting blood sugar. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Enzymatic method. Insulin. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: ELISA. Insulin resistance. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: formula. Total antioxidant capacity. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: Before the intervention and 8 weeks after starting. Method of measurement: Spectrophotometry. Anthropometric measurements (BMI, WHR, WC). Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Secca scale, non stretch meter. Energy and nutrient intake. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: 24-hour dietary recall questionnaire for 3 days (two on week days and one on a weekend or holiday). Physical activity. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: International Assessment of Physical Activity (IPAQ) questionnaire. Tabriz University of Medical Sciences Approved 2019-12-25 Ethics Committee of Tabriz University of Medical Science Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)