Clinical trial to evaluate the efficacy and safety of ChondroT on Knee-osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002693
- Lead Sponsor
- Dongshin University Mokpo Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
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)
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse Reaction;Clinical Laboratory;Vital Sign;Electrocardiogram