igella sativa in coronary artery disease

Phase 3

Conditions: coronary artery disease.
Atherosclerotic heart disease of native coronary artery
I25.1

Registration Number: IRCT20190506043494N1

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.