None listed
Conditions
Interventions
Drug : Experimental group : ChondroT 2g Bid, 4 Tablets per day, Oral administration.
Placebo group : Placebo Bid, 4 Tablets per day.
Sponsors
Dongshin University Mokpo Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are subject to clinical 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 year 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. Those with a daily average pain of 100mm(10mm pai Visual Analogue Scale) of 40mm or more during rest for the past week at the of visit 1 and visit 2 3. A person who has a Kellgren&Lawrence grade level of 2-3 through radiography(X-ray) at visit 1 4. Voluntarily agreed to participate and signed the consent form after hearing a clear explanation of the purpose and characteristics of this clinical trial
Exclusion criteria
Exclusion criteria: 1. A person who has undergone surgery on the knee due to degenerative Knee arthritis or other trauma 2. A post-traumatic degenerative Knee arthritis patient 3. Those sho have received intra-articular mucosal (viscosupplement; hylan, sodium hyalurinate, hyalulonan) supplement injection within 6 months of screening 4. A person who discharges joint fluid through intra-articular injection within 3 monts of Screening 5. A person who has received injection treatment such as prolotherapy or steroids in the cavity and around the knee sithin 3 months of screening 6. A persom who has received anti-psychotic treatment within three months of screening 7. A person who has received herbal treatment such as acupuncture, moxibustion, cupping, and herbal medicine within 4 weeks of screening 8. A person who has received non-drug topical treatment, such as physical therapy, within 4 weeks of screening 9. A person who is taking a health functional food that improves joint/cartilage health, including osteoarthritis treatment and glucosamine, within 4 weels of screening 10. A person who uses a local painkiller(pass, spray, etc.) at the knee joint within 7 days of random assignment 11. A person who has history or history of inflammatory diseases, tumors, trauma, rheumatoid arthritis, autoimmune diseases, severe external and internal degeneration of knee joints, inflammatory arthritis, hip diseases, or other inflammatory arthritis 12. Patients with psychiatric disorders, immune system disorders, and those on medication 13. Those who take adrenocortical hormone drugs, immunosuppressants, corticosteroids, cyclosorine, or other nonsteroidal anti-inflammatory analgesics for other diseases 14. A person whose ALT(GPT) or AST(GOT) is three times or more than the normal upper limit of the enforcement agency 15. A person whose Creatinine is more than twice the normal upper limit of the implementing agency 16.A person who has a history of gastrointestinal diseases(e.g.,Crohn's diseases) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of the product 17. A person with multiple sclerosis, connective tissue(teacher's) diseases 18. People with skin allergies, skin ulcers, and skin infection 19. A person who has history of drug or alcohol abuse 20. A person who has a history of notifying the main and components of a clinical trial drug or remedy 21.Patients with peptic ulcers, severe blood problems, severe liver problems, severe kidney problems, severe heart failure, and aspirin asthma 22. A person who is pregnant or has a plan of pregnancy during this clinical trial 23. A person who has participated in another clinical trial within 2 months of screening criteria or plans to participate in another clinical trial during the trial period (However, if he/she has participated in a non-material observation study, he/she may participate at the discretion of the test director) 24. A person who has determined that the tester is unfit to participate in a clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PGA: Patient's Global Assessment;100mm pain VAS(Visual Analogue Scale) ; Changes in the knee osteoarthritis symptom(KOOS : knee injury and Osteoarthritis Outcome Score); Changes in EQ-5D (Health Related Quality of Life) scores ;The amount of change in physical function test;Changes in ESR and CRP;The dose of an old-drug spill it out | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events ;Laboratory examination;Vital signs;Electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public Contactkim Seonjong
Dongshin University Mokpo Oriental Hospital
Outcome results
None listed