A Clinical study to evaluate the efficacy and tolerability of 5-LOXIN in patients with mild osteoarthritis of knee
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2020/10/028725
- Lead Sponsor
- Ju Yeong NS Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Subjects who signed an informed consent form voluntarily to participate in the study
Both gender, between 40 and 70 years.
VAS (Visual Analogue Scale) 30 to 70 mm.
K/L grade of knee I, II on X-ray
Subject with other than degenerative arthritis [osteoarthritis] determined by investigator.
Subject whose joint space is decreased by less than 2mm.
Subject with severe arthritis accompanied by bone spurs around joint, irregular articular surface, chondrogenesis, and bone cyst.
Subject with clinically significant cardiovascular, immunization, infective, or neoplastic diseases.
Subject being treated for gastritis or gastric ulcer.
Subject with uncontrolled hypertension (over 140/95mmHg measured at screening).
Subject with uncontrolled diabetes mellitus (more than 125mg/dl of fasting glucose measured at screening).
Subject with AST (GOT) and ALT (GPT) � 3 times the upper limit of normal.
Subject with Creatinine � 2 times the upper limit of normal.
Subject who is pregnant or planning to become pregnant within 3 months or who is lactating.
Subjects took intra articular injections including hyaluronic acid or subjects had corticosteroid therapy in last 3 months.
Subject administered medication including NSAIDs or health functional foods related to arthritis within 30 days of screening.
Subject with mental disorders such as schizophrenia, depressive disorder and drug intoxication /Subject with severe mental illness.
Subject planning to participate in the other clinical trial or subject participated in any clinical trial within 3 month.
Inappropriate subject decided by the investigator.
Subject who has septic arthritis, inflammatory joint disease, palindromic pseudogout, paget disease, joint fracture, ochronosis, acromegaly, hematochromatosis, Wilson disease, primary Osteochondrosis, genetic disorder (ex, hyperkinesia), collagen abnormality.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method