None listed
Conditions
Interventions
Drug : Experimental group : ChondroT 1g bid, 4 Tablets per day, Oral administration.
Experimental group : ChondroT 2g bid, 4 Tablets per day, Oral administration.
Placebo group : placebo bid, 4 Tab
Sponsors
Dongshin University Mokpo Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are subject to clinical diagnosis of ACR Clinical Classification Criteria for Osteoarthritis of the knee a. Pain in the knee b. And over 3 of the following 1) over 50 and under 80 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active motion 4) Bony tenderness 5) Bony enlargement 6) No palpable warmth of synovium 2. A daily mean Pain VAS(100mm Pain visual analog scale) = 40 ,during the past 1 week (0-100)
Exclusion criteria
Exclusion criteria: 1. Subjects who have had steroids shot around his knee in three months 2. Subjects who have received a mucosal supplement injection (hylane, sodium hyaluronate, hyalulonan, etc.) in the joint in the last 6 months 3. Subjectsl who had an aspiration of synovium within the past 6 months 4. Oriental medicine treatment of acupuncture, moxibustion, cupping therapy, herbal medicine, etc. for the past 4 weeks 5. Subjects who is on a diet Health Functional Foods including glucosamine to improve joint/cartilage health 6. An inflammatory disease, tumor, trauma, rheumatoid arthritis, autoimmune disease, severe bowel and inner degeneration of knee joints, secondary arthritis, hip disease, or other forms of inflammatory arthritis 7. Subjects had operation of knee 8. Subjects who uses local painkillers (pas, spray, etc.) on the knee joint within 3 days of randomization. 9. Subects who are allergic to the base and components for clinical testing medicine. 10. Subjects with renal function disorder (more than twice the normal limit of Serum creatinine) 11. Subjects who has received physical and local treatment, such as physical therapy, in the past two weeks 12. Subjects who has gastrointestinal conditions (e.g., Crohn's Disease) or gastrointestinal operations that could affect the absorption of test products (except for simple appendicitis or hernia) 13. Subjects participating in other clinical trials within two months to visiting the screening 14. Subjects with liver function disorder (exceeds the normal limit by more than three times) 15. Subjects with connective tissue (collagen) disease 16. Subjects with medical conditions such as multiple sclerosis 17. Taking immunosuppressant, cortico-steroid, cyclosporine, and osteoarthritis medications 18. Have been treated with antipsychotics within two months prior to screening 19. A history of drug or alcohol abuse 20. pregnant or nursing woman 21. Any fertile women who are likely to have a pregnancy that does not permit the implementation of appropriate contraceptives (excluding infertile women). 22. The research manager has determined that it is unsuitable for clinical testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survey VAS(visual analog scale);Korean-Western Ontario McMaster Univesities Osteoarthritis (K-WOMAC);Korean-Short Form Health Survey 36(KSF-36);Patient's Global Assessment(PGA);Physical function test;ESR, CRP | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Reaction;Clinical Laboratory;Vital Sign;Electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon-Jong Kim
Dongshin University Mokpo Oriental Hospital
Outcome results
None listed