The effect of of black seed oil on knee osteoarthritis

The effect of oral administration and topical application of black seed oil (Nigella Sativa) on pain, function and serum indices of inflammation and oxidative stress in patients with knee osteoarthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20081004001292N5

Enrollment

Registered

2019-01-22

Start date

2019-10-23

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Knee osteoarthritis. Other specified arthrosis

Interventions

Intervention 1: First intervention group: Edible Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, 2.5 ml twice a day in addition topical placebo oil containing paraffin manuf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate knee osteoarthritis

Exclusion criteria

Exclusion criteria: Rheumatologic disorder such as rheumatoid arthritis History of knee joint surgery History of lower limb bone fracture which encounter knee joint surface Severe knee osteoarthritis Neuropathic or sensory disorders Cutaneous disorder at knee area

Design outcomes

Primary

Measure	Time frame
Pain severity. Timepoint: Evaluating the pain scale at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: Visual Analogue Scale.;Osteoarthritis index. Timepoint: Evaluating activity at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.;Mobility. Timepoint: Evaluating mobility at the beginning of the study and six weeks after the intervention began. Method of measurement: Time up and go test.;Serum inflammatory high-sensitivity C-reactive protein index. Timepoint: Measuring serum level of C-reactive protein inflammatory factor at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay.;Serum stress oxidative index. Timepoint: Measuring serum level of total antioxidant capacity and 3,4-Methylene?dioxy?amphetamine at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay.	—

Measure

Time frame

Pain severity. Timepoint: Evaluating the pain scale at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: Visual Analogue Scale.;Osteoarthritis index. Timepoint: Evaluating activity at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.;Mobility. Timepoint: Evaluating mobility at the beginning of the study and six weeks after the intervention began. Method of measurement: Time up and go test.;Serum inflammatory high-sensitivity C-reactive protein index. Timepoint: Measuring serum level of C-reactive protein inflammatory factor at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay.;Serum stress oxidative index. Timepoint: Measuring serum level of total antioxidant capacity and 3,4-Methylene?dioxy?amphetamine at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

dolatkhahn@tbzmed.ac.ir+98 41 3336 1928

Outcome results

None listed

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