Evaluation of therapeutic effects of Crocina in knee osteoarthritis

Phase 3

Recruiting

• Conditions: osteoarthritis.; Primary osteoarthritis of other joints; M19.0

• Registration Number: IRCT20190419043318N1
• Lead Sponsor: Bojnourd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) aged over 40 years
2) Primary osteoarthritis
3) Pain in more than half the days of the previous month during one of the following activities: walking, climbing and stairs, standing up or sleeping on the bed or mattress during the night
4) Radiographic evidence of tibiafemoral or patellofemoral osteoarthritis
5) A score of 40 from the WOMAC scale as a base
6) No intra-articular injection of hyaluronic acid / glucocorticoid over the last six months
7) The lack of a positive pregnancy test or pregnancy program during the study

Exclusion Criteria

1) intolerance to the drug
2) Do not take medicine properly
3) Serious medical conditions that the patient can not regularly attend periodic visits include severe cardiovascular disease such as angina or heart attack, severe hypertension, recent stroke, insulin dependent diabetes, psychiatric disorders, kidney disease, liver disease, active concen , And anemia
4) history of liver disease
5) Inability to walk without a cane
6) A history of autoimmune diseases such as rheumatoid arthritis
7) Secondary osteoarthritis, for example, following a trauma

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Joint range of movement. Timepoint: Weeks 1,2,3,7,16. Method of measurement: Clinical examination.;Pain. Timepoint: Weeks 1,2,3,7,16. Method of measurement: VAS, KOOS and WOMAC questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change in serum levels of inflammatory mediators (IL-1? INF-?). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits.;Change in serum levels of inflammatory and anti-inflammatory mediators(IL-10). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits.