None listed
Conditions
Interventions
Medical Device : Study Group 1 receives HP Vitaran J, and Study Group 2 receives Lilied K. Each investigational device is administered as a 2 mL intra-articular injection per session. The intervention
Sponsors
Yonsei University, Wonju Severance Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 40 years or older and under 80 years 2) Participants who have voluntarily signed a written informed consent form 3) Participants who are able to understand and comply with the study procedures and visit schedule 4) Participants who are diagnosed with osteoarthritis according to the American College of Rheumatology (ACR) criteria at the Screening visit 5) Participants whose knee osteoarthritis severity corresponds to Kellgren–Lawrence grade I–III, as confirmed by knee X-ray at the Screening visit 6) Participants with a Visual Analogue Scale (VAS) score of at least 40 mm during weight-bearing at the Screening visit 7) Women of childbearing potential who agree to maintain an appropriate method of contraception during the study period
Exclusion criteria
Exclusion criteria: 1) Participants who have received intra-articular knee injections within 6 months prior to the Screening visit 2) Participants with a history of knee surgery 3) Participants with other medical conditions (including autoimmune diseases or history thereof, myocardial infarction, cardiac arrest, severe heart disease, or uncontrolled hypertension or history thereof) that may affect or interfere with treatment efficacy 4) Participants with chronic inflammatory diseases, such as rheumatoid arthritis 5) Participants who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours prior to the Screening visit 6) Participants who have taken immunosuppressive agents, such as cyclosporine A or azathioprine, within 6 weeks prior to the Screening visit 7) Participants with orthopedic conditions that may affect or interfere with treatment efficacy 8) Participants who have habitually taken psychotropic drugs or narcotic analgesics for one week or longer within 8 weeks prior to the Screening visit 9) Participants with psychological or psychiatric disorders that may interfere with participation in the clinical trial 10) Participants who, at the Screening visit, experience more severe pain in body areas other than the knee affected by osteoarthritis 11) Participants with ligament instability of Grade II or higher based on physical examination at the Screening visit (Grade 0: none, Grade I: 0–5 mm, Grade II: 5–10 mm, Grade III: >10 mm) 12) Participants with infection, skin disease, or other skin abnormalities at the injection site 13) Pregnant or breastfeeding women (Women of childbearing potential who require a pregnancy test, plan to become pregnant during the study period, or do not agree to use appropriate contraception are excluded) 14) Participants who have participated in another interventional clinical trial within 30 days prior to the Screening visit 15) Participants with hypersensitivity to lidocaine or other amide-type local anesthetics 16) Participants who are unable to communicate adequately or comply with study instructions 17) Participants who are otherwise deemed unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score for knee pain during weight-bearing | — |
Secondary
| Measure | Time frame |
|---|---|
| K-WOMAC (Korean Western Ontario and McMasters Universities);VAS score for knee pain at rest;Laboratory tests;Vital signs and physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungHwan Jang
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed