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IRCT20170513033941N61 IRCT 2019-07-22 Vice chancellor for research, Arak University of Medical Sciences Black seed effects on coronary heart disease The effects of black seed supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease 2017-09-05 anticipated 70 Complete https://irct.ir/trial/40730 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 70 by SPSS software (version 16) and participants will be 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, 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 supplements. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded. 3 Coronary Heart Disease. Intervention 1: Intervention group: Four N. Sativa containing capsules (Barij Essence, Kashan, Iran), 500 mg each capsule, daily, for 24 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran) daily for 24 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 Dr. Fariba Raygan
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 raygan.fariba2@gmail.com Kashan University of Medical Sciences scientific Dr. Fariba Raygan
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 raygan.fariba2@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients aged 45-85 years People diagnosed with type 2 diabetes and coronary heart disease 45 years 85 years Both 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: Four N. Sativa containing capsules (Barij Essence, Kashan, Iran), 500 mg each capsule, daily, for 24 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) daily for 24 weeks orally. Insulin resistance. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Calculation using homeostasis model of assessment insulin resistance formula. Fasting serum insulin levels. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit. Total cholesterol. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. High-density lipoprotein (HDL) cholesterol. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry. Vice chancellor for research, Arak University of Medical Sciences Approved 2017-09-02 Ethics committee of Arak University of Medical Sciences Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)