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IRCT20201126049495N1 IRCT 2020-12-10 Artesh University of Medical Sciences The effect of Nigella sativa oil on vascular function Comparison of the effect of Nigella sativa oil and placebo supplementation on flow mediated dilation (FMD) and vascular inflammatory biomarkers in subjects with cardiovascular disease risk factors 2020-12-21 anticipated 50 Complete https://irct.ir/trial/52737 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants will be randomly assigned, in a ratio of 1:1, to either Nigella sativa group or placebo group for 8 weeks. Stratified block randomization will be employed to assign subject to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, block size of 4-6 will be used with a 1:1 randomization between the two groups in each block, i.e. each block will consist of 2-3 subjects for the intervention group and 2-3 subjects for the placebo group. the predetermined allocation sequence of each block will be based on a computer-generated randomization list. An online program will be used for this purpose (www.randomizer.org). For each stratum, 8 blocks of 4 to 6 will considered and the sequence of patients in each block will be determined using software. Half of numbers in each block will be for the nigella sativa group and the other half for the placebo group, Blinding description: Patients are blinded of the type of supplement they are consuming, but the main investigator who assigns patients to intervention or placebo groups is not blinded. Nigella sativa oil and placebo supplements are given to patients in similar capsules. N/A Cardiovascular disease, Hypertension, diabetes, dyslipidemia. Intervention 1: Intervention group: Daily consumption of 2 capsules of 500 mg Nigella sativa oil for 8 weeks. Intervention 2: Control group: Daily consumption of 2 capsules of 500 mg mineral oil for 8 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 Said Hadi
The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2284 s.hadinu@yahoo.com Artesh University of Medical Sciences scientific Said Hadi
The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2284 s.hadinu@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age between 20-75 years Having at least one of cardiovascular disease risk factors (including diabetes, dyslipidemia, hypertension, smoking ) 20 years 75 years Both having BMI>30 Patients on nitrate or anticoagulant drugs Regular consumption (more than once in a week) of vitamins or minerals supplements during past month Chronic kidney disease stage 4 or 5 pregnancy R94.30 Abnormal result of cardiovascular function study, unspecified Treatment - Other Placebo Intervention group: Daily consumption of 2 capsules of 500 mg Nigella sativa oil for 8 weeks. Control group: Daily consumption of 2 capsules of 500 mg mineral oil for 8 weeks. Flow mediated dilation (FMD). Timepoint: Baseline and the end of the study. Method of measurement: sonography. Plasma ICAM-1. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Plasma VCAM-1. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Vice-Chancellor for Research, The Islamic Republic of Iran Army University of Medical Sciences Approved 2020-11-18 Ethics Committee of the Islamic Republic of Iran Army University of Medical Sciences The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran Tehran Tehran Iran (Islamic Republic of)