A Clinical study to evaluate the efficacy and tolerability of 5-LOXIN in patients with mild osteoarthritis of knee

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

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) â‰¥ 3 times the upper limit of normal.
Subject with Creatinine â‰¥ 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
Improvement from baseline to the end of the supplementation period in VAS (Visual Analogue Scale)	Screening, Day 14, Day 28 and Day 56

Secondary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study in WOMAC
Change from baseline to the end of the study in Bio-markers	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)	Day 14, Day 28 and Day 56

Trial Locations

Locations (2): Bajarang Memorial Fracture, Accidental and Surgical Centre
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Varanasi, UTTAR PRADESH, India
Sri Ram Ortho and Physio Rehab Centre (A unit of Anwesha Surgicals hospital Private Limited)
🇮🇳
Varanasi, UTTAR PRADESH, India
Bajarang Memorial Fracture, Accidental and Surgical Centre
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Nandlal Prasad
Principal investigator
9454976095
sunilverma.shiv@gmail.com