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IRCT20190506043494N1 IRCT 2019-11-08 Tabriz University of Medical Sciences Nigella sativa in coronary artery disease The effects of nigella sativa extract oil supplementation on plasma level of ICAM-1, VCAM-1 , metabolic and oxidative parameters and nutritional status in paients with coronary artery disease 2019-11-22 anticipated 46 Complete https://irct.ir/trial/39337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible participants will be randomly allocated to intervention and placebo groups using a software-generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Nigella sativa capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company. 3 coronary artery disease. Intervention 1: Intervention group: Patients in this group will receive Nigella sativa soft gel capsule for 8 weeks. Nigella sativa soft gel is a containing 1 gram of Nigella sativa oil and used twice a day. Intervention 2: Control group: Patients in this group will receive avicel capsules for 8 weeks which are same size and shape, and used once a day. 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 no decision has been made yet
public omid mohammad tavakoli rouzbehani
Golgasht street, Tabriz university of medical sciences
tabriz Iran (Islamic Republic of) 5166614711 +98 41 3381 1902 omidmtr@gmail.com Tabriz University of Medical Sciences scientific Dr mohammad alizadeh
Golgasht street, Tabriz university of medical sciences
tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 mdalizadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) age between 35-65 years BMI between 25 -45 Proof of 50% stenosis in at least one of the major coronary arteries in angiography Ability and willingness to collaborate on the project 35 years 65 years Both Any cardiovascular , kidney and chronic diseases consumption of herbal or nutritional supplements in the last 1-2 months heart failure function class 3 , 4 use of medicine or surgery for weight loss Use of cigarettes, alcohol and drugs pregnancy or lactation taking niacin and fibrates I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Placebo Intervention group: Patients in this group will receive Nigella sativa soft gel capsule for 8 weeks. Nigella sativa soft gel is a containing 1 gram of Nigella sativa oil and used twice a day. Control group: Patients in this group will receive avicel capsules for 8 weeks which are same size and shape, and used once a day. ICAM serum level. Timepoint: baseline and 8 week after intervention. Method of measurement: measurement via ELISA kit. VCAM serum level. Timepoint: baseline and 8 week after intervention. Method of measurement: measurement via ELISA kit. Lipid profile including HDL, LDL, TC and TG. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: HDL, TC and TG via enzymatic kit, LDL via friedewald equation. Oxidative stress indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) and Superoxide dismutase by spectrophotometry. Glycemic indices including FBS, HbA1C, insulin, HOMA-IR. Timepoint: before and after the 8 weeks supplementation. Method of measurement: Elisa and spectrometer. Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory scale. Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via IPAQ questionnaire. Quality of life. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via MacNew questionnaire. Tabriz University of Medical Sciences Approved 2019-10-14 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. tabriz East Azarbaijan Iran (Islamic Republic of)