]>
IRCT20121216011763N53 IRCT 2021-08-10 Esfahan University of Medical Sciences Evaluation of the effect of curcumin-piperine in the treatment of rheumatoid arthritis The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis: a double-blind clinical trial study 2021-12-22 anticipated 54 Complete https://irct.ir/trial/57120 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex. It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it, Blinding description: In order to conduct this research in a double-blind manner, before starting the study, the total capsules are coded in A and B by a person other than the researcher, so that both groups do not know the type of capsules received by both groups. To keep track of people in the study groups using the capsules, they will be contacted weekly by phone or text message and will be reminded of the capsule use. To check patients' compliance, curcumin and placebo capsules are given to them on a monthly basis and they are asked to deliver the previous capsule pack so that we can give them the new pack. Capsule use is also reminded and evaluated by weekly phone calls and text messages. 3 Rheumatoid Arthritis. Intervention 1: Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine) for 12 weeks. They will also receive diet and exercise advice.Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition. Intervention 2: Control group: They will receive one placebo capsule (505 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition. Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: askari@mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Mohammad Bagherniya
Hezarjarib Ave
ISFAHAN Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari
Hezarjarib Ave
ISFAHAN Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age: 30-70 years Complete informed consent Rheumatoid arthritis according to the rheumatologist according to the criteria of the American College of Rheumatology 2010 Disease activity score higher than 5.1 and total soft joint count (TJC) and swollen joint count (SJC) higher than 8 30 years 70 years Both Pregnancy and lactation Smoking Heart, lung, kidney, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, uncontrolled diabetes, hypothyroidism, Cushing's syndrome Weight loss and bariatric surgery in the last year. Lack of following a special diet and herbal supplements M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine) for 12 weeks. They will also receive diet and exercise advice.Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition. Control group: They will receive one placebo capsule (505 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition. Total antioxidant capacity (TAC). Timepoint: Beginning and end of the study. Method of measurement: Colorimetric method. C-reactive protein (CRP). Timepoint: Beginning and end of the study. Method of measurement: Colorimetric analysis method and by autoanalyzer. ESR. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method. Clinical signs. Timepoint: Beginning and end of the study. Method of measurement: Diagnosis by a specialist and validated questionnaires. Superoxide dismutase (SOD). Timepoint: Beginning and end of the study. Method of measurement: Colorimetric method. Malondialdehyde (MDA). Timepoint: Beginning and end of the study. Method of measurement: Colorimetric method. Rheumatoid factor (RF). Timepoint: Beginning and end of the study. Method of measurement: ELISA. Esfahan University of Medical Sciences Approved 2021-04-21 Ethics committe of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue ISFAHAN Isfehan Iran (Islamic Republic of)