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The effect of saffaron tablet on the level of inflammatory markers with knee osteoarthritis patients

Phase 2
Conditions
Knee Osteoarthritis.
Bilateral primary osteoarthritis of knee
Registration Number
IRCT2016091029777N1
Lead Sponsor
Vice chancellor for research, Golestan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Knee osteoarthritis patients based on American College of Rheumatology(ACR) diagnostic criteria with an intensity of 2 to 3 according to Kellgren and Lawrence(KL) radiography grade, Patients with an average age of 50 to 70 years old;
Exclusion criteria: Known hypersensitivity to Saffron, Patients with other rheumatologic diseases, Patients with active malignant disease or infection, Patients with known mental illness, Patients with a history of recent Knee surgery and severe trauma(within 6 months), Patients with hip osteoarthritis, Patients with septic arthritis, Patients with active gastrointestinal bleeding or a history of it, Patients with chronic kidney disease when the estimated Glomerular Filtration Rate(GFR) is less than 30 ml/min/1.73m2, Severe leukopenia, Patients requiring long term use of corticosteroids such as asthma or inflammatory bowel disease.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum levels of TNF alpha. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: pg/ml.;Serum levels of IL 1 beta. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: pg/ml.
Secondary Outcome Measures
NameTimeMethod
The intensity of osteoarthritis. Timepoint: Baseline and sixth and twelfth weeks. Method of measurement: WOMAC questionnaire.
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