A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Conjuran®(Polynucleotide) Compared to Hyruan Plus®(Sodium hyaluronate), Synovian®(BDDE cross-linked sodium hyaluronate) in Patients with Knee Osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005308
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
(1) Adult over 40 years old
(2) Knee osteoarthritis patients of Grade I-III according to Kellgren-Lawrence grading scale (K-L grade)
(3) 100mm VAS (visual analogue score) for pain during weight load more than 40mm in at least one joint of the bilateral knee joint
(4) Patients who voluntarily submit written consent to participate in clinical trials and are expected to comply with the testing procedures
(1) Patients with severe trauma or fracture history of the indicator knee joint that may affect clinical trials
(2) Those with rheumatoid arthritis or other metabolic arthritis
(3) Patients with an infection (osteomyelitis, etc.) around the indicator knee joint
(4) Those who have joint replacement surgery or procedures in the indicator knee joint
(5) Those who have hip joint osteoarthritis in ipsilateral side of the indicator knee joint
(6) Patients with other diseases that may affect the safety and effectiveness evaluation of the indicator knee joint (e.g., patients with severe pain, such as complex site pain syndrome, Paget's disease, intervertebral disc prolapse, and gout, recurrent pseudogout)
[However, it is possible to register in the case of degenerative diseases such as spinal stenosis, which are judged by the investigator to not affect the evaluation of the index knee joint.]
(7) Patients who received intraarticular hyaluronic acid injections within the previous three months of baseline (before study) or those who received intra-joint steroid injections within one month
(8) Those who received anticoagulants or platelet aggregation inhibitors within one week prior to the baseline (before study)
Injectable anticoagulants: low molecular weight and non-fractional heparin injections, etc.
Oral anticoagulants: Warfarin, Dabigatran, Rivaroxaban, etc.
Oral antiplatelets: aspirin, clopidogrel, prasugrel, ticagreler, etc.
[However, if you take a low dose of aspirin (300mg / day or less) for the purpose of treatment and management of cardiovascular disease, registration is possible]
(9) Patients who received physiotherapy (including herbal therapy, thermal therapy, taping therapy, etc.) in the baseline (before study) within two weeks prior to the indicator knee joint
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analogue scale (VAS);Korean version of Western Ontario and McMaster Universities(K-WOMAC);European quality of life-5 dimension(Euro-QoL-5D);analgesic comsumption;PainDETECT;CGI(Clinical global imperssion), PGI(patient's global impression)
- Secondary Outcome Measures
Name Time Method Safety