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IRCT20170513033941N63 IRCT 2019-08-10 National Institute for Medical Research Development of Iran (NIMAD) The effects of curcumin supplementation in patients with coronary heart disease The effects of curcumin supplementation on parameters of mental health, biomarkers of oxidative stress and gene expression related to insulin, lipid and inflammation in type 2 diabetic patients with cardiovascular disease 2019-06-17 anticipated 60 Complete https://irct.ir/trial/41043 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Coronary Heart Disease. Intervention 1: Intervention group: 1000 mg curcumin, once a day, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. 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 Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Patients aged 45-85 years People diagnosed with type 2 diabetes and coronary heart disease. 45 years 85 years Both Exclusion Criteria: Patients with thyroid disorders. Severe renal insufficiency hepatic failure Those experiencing an acute myocardial infarction within the past 3 months Patients undergoing cardiac surgery within the past 3 months I25.9 Chronic ischemic heart disease, unspecified Treatment - Drugs Placebo Intervention group: 1000 mg curcumin, once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Expressed levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of LDL-R gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of TGF-beta gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Expressed levels of VEGF gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: RT-PCR. National Institute for Medical Research Development of Iran (NIMAD) Approved 2019-06-16 Ethics committee of National Institute for Medical Research Development of Iran (NIMAD) National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)