Evaluation of b-Caryophyllene in osteoarthritis patients

Phase 2

Conditions: Osteoarthritis of knee.
Osteoarthritis of knee

Registration Number: IRCT20180103038199N9

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 120

Inclusion Criteria

Lack of proper response (having a score higher than 30 on the VAS numerical-visual scale at the beginning of the study) to the analgesic drug meloxicam after at least two weeks of drug administration before the start of the study
Age between 40-70 years old
Patients with BMI lower than 37

Exclusion Criteria

Patient's dissatisfaction with continued cooperation during the study
Need to perform any new therapeutic interventions during the study period
Active liver or kidney disease and malignancies
Secondary or suspected osteoarthritis
Patients treated with hormonal medicines
Patients treated with anticoagulants
Patients with a history of ischemic or hemorrhagic stroke
Patients with a history of deep vein thrombosis
Treatment with oral corticosteroids 4 weeks before the start of the study
Intra-articular injection of hyaluronic acid three months before the start of the study
Pregnancy
Patients who have had intra-articular corticosteroid injections in the last 4 weeks

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical indicators of osteoarthritis. Timepoint: At the beginning of the study and every week until the eighth week. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) standardized questionnaire.

Secondary Outcome Measures

Name	Time	Method
Complete Blood Cell Count with Differential. Timepoint: At the beginning and the end of the study. Method of measurement: Using an auto-analyzer system.;Interleukin-4 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;Interferon-gamma level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;Interleukin-10 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;High-sensitivity C-reactive protein (hs-CRP) level. Timepoint: At the beginning and the end of the study. Method of measurement: Using a laboratory kit.