The effect of black cumin on non alcholic fatty liver

The clinical trial of evaluation of the effect of black cumin (nigella sativa) extract supplementation on serum levels of some inflammatory markers, liver enzymes, lipid profile ,insulin and fasting plasma glucose in patients with non-alcoholic fatty liver disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017012232109N1

Enrollment

Registered

2017-03-12

Start date

2017-04-24

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Non alcholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Black Seed Oil, 1000 mg capsule, once a day for 8 weeks. Intervention 2: Control group: paraffin oil, 1000 mg capsule, once a day for 8 weeks.

Treatment - Other

Placebo

Intervention group: Black Seed Oil, 1000 mg capsule, once a day for 8 weeks.

Control group: paraffin oil, 1000 mg capsule, once a day for 8 weeks

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients aged 20 to 60 years diagnosed with nonalcoholic fatty liver by ultrasound, confirmed by a radiologist and a gastroenterologist. Exclusion criteria: pregnancy and lactation; liver transplantation; smoking; alcohol and drug abuse; consuming drugs such as corticosteroids, amiodarone, tamoxifen, methotrexate; receiving total parenteral nutrition; rapid weight loss; diabetes; heart failure; thyroid problems; kidney disease; hereditary hemochromatosis and Wilson disease; have a positive test for hepatitis C, B and autoimmune hepatitis; alpha-1 antitrypsin deficiency.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Tumor necrosis factor. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Interleukin 6. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Liver enzymes(aspartate aminotransfrase,alanin aminotransferase,gama glutamil transferase). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;C reactive protein. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Lipid profiles(triglycrid,HDL,LDL and total chollestrol). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;Insulin. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Fast blood sugar. Timepoint: before and 8 weeks after intervention. Method of measurement: Enzymatic chlorometric method.	—

Measure

Time frame

Tumor necrosis factor. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Interleukin 6. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Liver enzymes(aspartate aminotransfrase,alanin aminotransferase,gama glutamil transferase). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;C reactive protein. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Lipid profiles(triglycrid,HDL,LDL and total chollestrol). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;Insulin. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Fast blood sugar. Timepoint: before and 8 weeks after intervention. Method of measurement: Enzymatic chlorometric method.

—

Secondary

Measure	Time frame
Waist to hip ratio. Timepoint: before and 8 weeks after intervention. Method of measurement: Inelastic tape without putting pressure on the body.;Body mass index. Timepoint: before and 8 weeks after intervention. Method of measurement: The ratio of weight in kilograms by the square of height in meters.;Systolic and diastolic blood pressure. Timepoint: before and 8 weeks after intervention. Method of measurement: Sphygmomanometer.	—

Measure

Time frame

Waist to hip ratio. Timepoint: before and 8 weeks after intervention. Method of measurement: Inelastic tape without putting pressure on the body.;Body mass index. Timepoint: before and 8 weeks after intervention. Method of measurement: The ratio of weight in kilograms by the square of height in meters.;Systolic and diastolic blood pressure. Timepoint: before and 8 weeks after intervention. Method of measurement: Sphygmomanometer.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad rashidmayvan

Ahvaz University of Medical Sciences

rashidmayvan.m@ajums.ac.ir+98 61 3333 3050

Outcome results

None listed

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