Nigella Sativa oil for treatment of Behcet's disease

A study of the effect of Nigella Sativa oil on control of disease activity and serum levels of IL-10, TNF-a, and oxidative stress markers in patients with Behcet's disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201511086975N5

Enrollment

Registered

2015-12-12

Start date

2016-01-01

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

Behcet’s Disease. Behcet’s Disease, unspecified

Interventions

Intervention 1: Case group will receive soft gels containing 1000 mg Nigella Sativa oil per day for 6 months. Soft gels will be used after breakfast. Intervention 2: Control group will receive soft

Treatment - Drugs

Case group will receive soft gels containing 1000 mg Nigella Sativa oil per day for 6 months. Soft gels will be used after breakfast.

Control group will receive soft gels containing 1000 mg (starch) per day for 6 months. Soft gels will be used after breakfast.

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age older than 16; Having active Behcet’s disease: Iranian's Behcet's Disease Dynamic Activity Measure (IBDDAM) more than 2.5 Exclusion criteria: Consumption of Nigella Sativa oil supplements in the past 8 weeks; Pregnancy and lactation; Liver disease; Renal insufficiency

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Behcet's disease activity. Timepoint: Before, 2, 4, and 6 months after intervention. Method of measurement: Iranian's Behcet's disease activity measure.;Plasma levels of TNF-a, IL-10, oxidant and antioxidant systems (total antioxidant, malondialdehyde). Timepoint: Before and 2 months after intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay.	—

Secondary

Measure	Time frame
Nigella Sativa oil side effects. Timepoint: 2, 4, and 6 months after intervention. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSusan kolahi

Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences

susan.kolahi@gmail.com+98 41 3337 3966

Outcome results

None listed

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