MedPath

Effect of Nigella sativa oil on knee osteoarthritis

Phase 2
Recruiting
Conditions
Osteoarthritis.
Osteoarthritis, unspecified site
Registration Number
IRCT20080901001157N13
Lead Sponsor
Iranian academic center for education culture and research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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