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Effect of nigella sativa oil extract in patients with type 2 diabetes mellitus

Effect of nigella sativa oil extract on insulin resistance,oxidative stress and inflammatory indices in patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201307221640N13
Enrollment
50
Registered
2014-07-06
Start date
2013-03-20
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

Diabtes type 2. Non-insulin dependent diabetes mellitus

Interventions

Intervention 1: Intervention group: Received 500mg Nigella sativa oil two times a day orally for two months. Intervention 2: Placebo group: Received 500mg mineral oil orally two times a day for two mo
Treatment - Drugs
Intervention group: Received 500mg Nigella sativa oil two times a day orally for two months
Placebo group: Received 500mg mineral oil orally two times a day for two months

Sponsors

Vice Chancellor for research of Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: subjects between 18-60 years old; type 2 diabetic patients without insulin therapy; patients with history of diabetes more than one year; patients with body mass index between 18 to 35 kg/m2. Exclusion criteria: pregnant or lactating women; smokers and alcohol consumers; patients consume antioxidant supplements (vitamin E and C, caroteniodes and coQ10); patients with cardiac, hepatic, respiratory and chronic renal diseases; patients with acute or chronic inflammation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic colorimetric.;Fasting insulin serum. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA assay.;HbA1C (Glycosilated hemoglobin). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: HOMA-IR calculation.

Secondary

MeasureTime frame
Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).;TNF-a. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.;IL-1ß. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Anthropometric index(weight and Body Mass Index). Timepoint: before and after 8 weeks intervention. Method of measurement: Analogue scale for weight and weight(Kg)/Square Height for body mass index.;Serum malondialdehyde(MDA). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.;Nitret oxid(NO). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.;SOD activity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.;Catalase enzyme activity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: spectrophotometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Hadi

Beheshti University of Medical Sciences

s.hadinu@yahoo.com+98 21 2236 0658

Outcome results

None listed

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