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Efficacy of Nigella sativa L. seed oil in treatment of type 2 diabetes

Efficacy of Nigella sativa L. seed oil in treatment of type 2 diabetic patients: a placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201207301157N7
Enrollment
70
Registered
2013-08-08
Start date
2012-05-22
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

Diabetes. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention group: Received 2.5 ml N. sativa oil two times a day orally for three months. Intervention 2: Placebo group: Received 2.5 ml mineral oil orally two times a day for three m
Treatment - Drugs
Placebo
Intervention group: Received 2.5 ml N. sativa oil two times a day orally for three months
Placebo group: Received 2.5 ml mineral oil orally two times a day for three months

Sponsors

Vice chancellor for research, Institute of Medicinal Plants
Lead Sponsor
Vice chancellor for research, Religion and Medicine Research Center, Baqiyatallah University of Medi
Collaborator

Eligibility

Sex/Gender
All
Age
34 Years to 63 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Type 2 diabetic patients with fasting blood glucose levels between 140 and 180 mg/dl; body weight between 55 and 75 kg; age between 34 and 63 years; disease duration of 2 to 8 years; taking no more than two 500 mg metformin and two 5 mg glyburide tablets every day. Exclusion criteria: Patients receiving insulin therapy; patients with cardiac, renal, hepatic and hematological diseases; patients with a history of gallstones or gall bladder surgery; patients using estrogen, steroid, beta-blocker and thiazide drugs; pregnant and breast-feeding women; alcohol consuming and cigarette smoking patients.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood glucose level was determined in laboratory by commercially available kit.;Glycosylated hemoglobin (HbA1C). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood HbA1c level was determined in laboratory by commercially available kit.;2 hours postprandial blood glucose. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood glucose level was determined in laboratory by commercially available kit.

Secondary

MeasureTime frame
BMI (Body mass index). Timepoint: At starting of the study and after 3 months. Method of measurement: Height and weight using measure tape and weight scales.;Triglyceride. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood triglyceride level was determined in laboratory by commercially available kit.;Cholesterol. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood cholesterol level was determined in laboratory by commercially available kit.;Low-density lipoprotein (LDL). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood LDL level was determined in laboratory by commercially available kit.;High-density lipoprotein (HDL). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood HDL level was determined in laboratory by commercially available kit.;Serum glutamic oxaloacetic transaminase (SGOT). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood SGOT level was determined in laboratory by commercially available kit.;Serum glutamic pyruvic transaminase (SGPT). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood SGPT level was determined in laboratory by commercially available kit.;Creatinine. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood creatinine level was determined in laboratory by commercially available kit.;Alkaline phosphatase (ALP). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood ALP level was determined in laboratory by commercially available kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHasan Fallah Huseini

Institute of Medicinal Plants

huseini_fallah@yahoo.com+98 26 3476 4010

Outcome results

None listed

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