Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: 5-Loxin: One capsule (250mg) daily after meal for 56 days administered Orally
Control Intervention1: Placebo: One capsule (250mg) daily after meal for 56 days administered Orally
Sponsors
Ju Yeong NS Co Ltd
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement from baseline to the end of the supplementation period in VAS (Visual Analogue Scale) Timepoint: Screening, Day 14, Day 28 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study in Bio-markersTimepoint: Day 1 and Day 56;Change from baseline to the end of the study in Improvement in osteoarthritis by Subject Global Assessment (SGA) and Physician Global Assessment (PGA)Timepoint: Day 14, Day 28 and Day 56;Change from baseline to the end of the study in WOMAC Timepoint: Day 1, Day 14, Day 28 and Day 56 | — |
Countries
India
Contacts
Public ContactAlluri Venkata Krishna Raju
Laila Nutraceuticals
Outcome results
None listed