* A Pilot study * Randomized and Double-blinded * Placebo controlled * In 2 parallel group (JOINS 200mg:Placebo = 1:1) * Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months) * Provide rescue medicine throughout whole clinical trial period.
1. Assessment of Efficacy 1. Knee MRI(Magnetic resonance imaging): * Assessment of cartilage volume, thickness in target knee * GAG(glycosaminoglycan) concentration of target knee * Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee 2. Knee radiography: * Assessment of changes in minimal medial JSW(Joint Space Width) of target knee. 3. Knee pain(VAS) * Assessment changes of pain in target knee. 4. K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean) * Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions). * The questionnaire is self-administered by the patients. 5. Used frequency of rescue medicine. 6. Biochemical cartilage and bone markers * Blood and urine sample will be collected all through the morning after a night fasting period since 10 pm the previous day to avoid the variations. 2. Assessment of Safety 1. Adverse event 2. Laboratory assessment 3. Vital sign 4. 12-lead ECG 5. Physical examination 3. Enrollment: 76
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
1 tablet at each time, 3 times a day
placebo of Joins 200mg
Seoul National University hospital
Seoul, South Korea
Knee MRI
Time frame: up to 4 times
Knee radiography
Time frame: up to 4 times
Knee pain(VAS)
Time frame: up to 6 times
K-WOMAC
Time frame: up to 6 times
Consumption of rescue medication
The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
Time frame: up to 6 times
Biomarker
Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.
Time frame: up to 6 times
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.