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IRCT20180619040151N2 IRCT 2018-12-27 Mashhad University of Medical Sciences The effect of curcumin on arterial stiffness The effect of curcumin supplementation on non invasive arterial stiffness indices in metabolic syndrome patients 2019-01-21 anticipated 80 Complete https://irct.ir/trial/32041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, stratified randomization will be used. First, the participants will be stratified based on age and sex (male or female) and then they will be allocated to intervention or placebo group based on the blocks of size 4. Blocks of size 4 have 10 modes(AABB, ABAB, BBAA, BABA, AAAB, BBBA, AAAA, BBBB, ABBB, BAAA), Blinding description: In this study, the original researcher who is responsible for randomization, Giving supplements and drafting the article is blind. Also, participants are aware of their participation in the research project but they do not know which study group they are in. The sphygmocor apparatus operator, which is responsible for evaluating arterial stiffness indices, is also blind in this study. 3 metabolic syndrome. Intervention 1: Intervention group: Receiving a single dose of curcumin (500 mg) for 12 weeks. Patients receive their supplement every four weeks. Supplement should be eaten with food. Intervention 2: Control group: Receiving a single dose of placebo for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Abdolreza Norouzy
Azadi-squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3800 2382 norouzya@mums.ac.ir Mashhad University of Medical Sciences scientific Abdolreza Norouzy
Azadi-squre
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3800 2382 norouzya@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and the completion of informed consent form Metabolic syndrome Patients 30 years 70 years Both Curcumin sensitivity Regular use of anti-diabetes drugs, antiplatelet drugs, antioxidant supplements, anti-inflammatory drugs, analgesics Use of multivitamin or herbal supplements at least 3 months before the start of the study Liver disease, autoimmune disease, biliary disease, obstructive disease, diabetes, kidney failure, malignancy, kidney stones, calcium oxalate stones Pregnancy and breastfeeding Drug abuse Smoking hookah or cigarettes Prevention Placebo Intervention group: Receiving a single dose of curcumin (500 mg) for 12 weeks. Patients receive their supplement every four weeks. Supplement should be eaten with food. Control group: Receiving a single dose of placebo for 12 weeks. Pulse wave velocity. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Central Augmentation Index. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Central Augmentation Index75. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Central augmentation pressure. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Brachial blood pressure. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Central blood pressure. Timepoint: At the beginning and the end of the study. Method of measurement: Sphygmocor xcel. Mashhad University of Medical Sciences Approved 2018-12-10 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)