Skip to content

Effect of Nigella sativa oil on knee osteoarthritis

Effects of oral Nigella sativa seed oil on osteoarthritis indexes in patients suffering from knee osteoarthritis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001157N13
Enrollment
80
Registered
2018-03-27
Start date
2018-04-20
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Osteoarthritis. Osteoarthritis, unspecified site

Interventions

Intervention 1: Intervention group: Nigella sativa oil emulsion
Patients taking a tablespoon of nigella sativa oil emulsion three times a day after food (5 ml nigella sativa oil daily) for one month. Intervention 2: Placebo group: Placebo emulsion
Patients taking a tablespoon of placebo emulsion three times a day after food ( total 5 ml mineral oil taking per day) for one month.

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: Male or female patients with knee osteoarthritis 1 or 2 intensity according to physical examination and knee joint radiography Age 50 to 70 years Exacerbation of the disease at a rate of at least 2 units of sub-total pain score after discontinuation of analgesic drugs which was used at least 3 days a week during the last month A minimum of 9 points out of 20 for pain, joint stiffness and physical activity of the patient according to the criteria of Western Ontario and McMaster Universities pain subscale index after discontinuing analgesic drug medications

Exclusion criteria

Exclusion criteria: Patients with secondary osteoarthritis due to a known disease Patients with history of arthroscopy, surgery, knee replacement and injection to the knee joint during the last 6 months Any serious systemic disease and other chronic inflammatory disease Patients receiving steroid anti-inflammatory drugs, muscle relaxant, antidepressants, glucosamine, chondroitin, tramadol, topical analgesic agents Like the capsaicin Alcohol consuming and drug abuse patients Patients who refuse to stop analgesic drugs No flares after discontinuation of analgesic drugs that using at least 3 days a week during the last months Breast-feeding, pregnant women and who intend to have children

Design outcomes

Primary

MeasureTime frame
Severity of arthritis. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.;Extent of joint pain. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.;Extent of joint stiffness. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.;Extent of physical function. Timepoint: Before and end of intervention after 1 month. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index Questionnaire.

Secondary

MeasureTime frame
Dose of acetaminophen used. Timepoint: Before intervention and after 1 month at end of the intervention. Method of measurement: Daily recording of the acetaminophen dose used by the patient.;Pain intensity. Timepoint: Before and end of the study and after one month. Method of measurement: Visual Analog Scale questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFallah Huseini Hasan

Iranian academic center for education culture and research

h.fallah@acecr.ac.ir+98 26 3476 4010

Outcome results

None listed

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