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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190506043494N1

Enrollment

Registered

2019-11-08

Start date

2019-11-22

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease. Atherosclerotic heart disease of native coronary artery

Interventions

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

Eligibility

Sex/Gender

All

Age

35 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactomid mohammad tavakoli rouzbehani

Tabriz University of Medical Sciences

omidmtr@gmail.com+98 41 3381 1902

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026