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IRCT20170513033941N67 IRCT 2019-11-30 Vice chancellor for research, Kashan University of Medical Sciences The effects of melatonin supplementation in the treatment of rheumatoid arthritis Study of the effects of melatonin supplementation on clinical status and metabolic profiles in patients with rheumatoid arthritis 2019-10-23 anticipated 66 Complete https://irct.ir/trial/43368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes. Supplements and placebos are in the same packaging at the Pharmaceutical company. Only the code is written on the packages. Patients and researchers do not know the type of intervention and after analyzing the data, packet codes are decoded, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Rheumatoid arthritis. Intervention 1: Intervention group: 6 mg/day Melatonin (RAZAK, Iran), one hour before bedtime for 12 weeks. Intervention 2: Control group: Placebo (Barij Essence, Iran), one hour before bedtime for 12 weeks. 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 Undecided - It is not yet known if there will be a plan to make this available
public Amirhossein Loghman
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0021 amirhosseinloghman@gmail.com Kashan University of Medical Sciences scientific Dr. Kamal Esalatmanesh
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 kamalesalatmanesh@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with rheumatoid arthritis Individuals aged 20-80 years old 20 years 80 years Both Patients with infectious, malignant and other inflammatory diseases those taking melatonin supplements or antioxidant supplements within 3 months prior to enrollment in the study the night shift workers subjects taking antibiotics medications unwillingness to cooperate Patients with thyroid diseases Current smokers Rheumatoid arthritis patients who were diagnosed less than on 1 year before the start of the study M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo Intervention group: 6 mg/day Melatonin (RAZAK, Iran), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Iran), one hour before bedtime for 12 weeks. CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Qualitative (Negative, +1, +2 and +3). ESR. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: mm/h. Disease activity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: DAS28-ESR (using a questionnaire for VAS and a checklist to note physical examination results). Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione peroxidase. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Vice chancellor for research, Kashan University of Medical Sciences Approved 2019-10-21 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)