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Evaluation of the effect of Elaeagnus angustifolia alone and in combination with Boswellia thurifera compared with ibuprofen in patients with knee osteoarthritis

Not Applicable
Conditions
knee osteoarthritis.
Other primary gonarthrosis
Registration Number
IRCT2015072123282N1
Lead Sponsor
Barij Essence Pharmaceutical Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
75
Inclusion Criteria

age of 40 - 80 years; Osteoarthritis of at least one knee for at least 6 months based on the diagnostic criteria of American College of Rheumatology (ACR); Pain score > 40 mm based on the visual analogue scale (VAS); CRP serum level < 10 mg/dL; LPFI (Lequesne Pain and Function Index) score > 7; Grade 2 or 3 of Kellgren-Laurence scale in knee radiography within the past 6 months

Exclusion criteria: Dysfunction of either liver, kidneys, or cardiovascular system or malignancy; Use of intra-articular glucocorticoids within the past 3 months; Use of intra-articular sodium hyaluronate within the past 6 months; Use of systemic glucocorticoids (either oral or parenteral) within the past 3 months; Having other osteoarticular disorders (e.g., rheumatoid arthritis and gout); Uncontrolled hypertension (> 140/90 mm Hg); Increased ESR; Having gastric or duodenal ulcers (based on the medical history); Sensitivity to the intervention drug; Being candidate for arthroplasty surgery; Not use of the intervention drug for more than one week; Knee arthroscopy within the past 3 months; Illiteracy

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
equesne's Pain and Function Index (LPFI). Timepoint: before the intervention and 4 weeks after the intervention. Method of measurement: Questionnaire.;Visual analogue scale (VAS). Timepoint: before the intervention and 4 weeks after the intervention. Method of measurement: scoring on the scale.;Patient global assessment (PGA). Timepoint: before the intervention and 4 weeks after the intervention. Method of measurement: scoring on the scale.
Secondary Outcome Measures
NameTimeMethod
Adverse effects. Timepoint: during the intervention. Method of measurement: patient report.
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