This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
Primary efficacy variable: Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale Secondary efficacy variables: * Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale * Number of patients showing a 20% reduction from baseline in VAS-pain * Number of patients showing a 50% reduction from baseline in VAS- pain * Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo * Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only) * Consumption of rescue medication * Investigator's Global assessment of efficacy * Subject's global assessment of efficacy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
Carboxy Methyl Cellulose
Nasik
Nashik, Maharashtra, India
Pune
Pune, Maharashtra, India
WOMAC - pain subscale
Time frame: 56 Days
Clinical Adverse Events
Time frame: 56 Days
Laboratory Adverse Events
Time frame: 56 Days
Assessment of Tolerability by the Subject
Time frame: 56 Days
Visual Analog Scale - Pain
Time frame: 56 Days
Consumption of Rescue Medication
Time frame: 56 Days
Investigator's and Subject's Global Assessment
Time frame: 56 Days
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