A Study for Moderate Osteoarthritis of the Knee

Study Overview
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Brief Summary
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This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.

Detailed Description
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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

Official Title
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A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Flexsure Capsules
* Dietary Supplement: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory male or female patients aged 30-65 years, and diagnosed of OA of the knee according to the ACR clinical and radiographic criteria ARA functional class II or III Kellgren Lawrence radiological severity of Grade II, Grade III OA knee Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be more than 40 and less than 80 in the previous 24 hrs at screening and baseline visits Exclusion Criteria: Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease BMI >35 kg/m2 Indication of surgery for OA knee Arthroscopy of either knee in the past year Use of analgesics or any other symptom-relieving medication within 7 days of screening Use of systemic steroids or herbal medication for OA within 4 weeks of screening Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months History of osteoporotic/ osteoarthritic fractures within the past 6 months Pregnant or lactating women or women with inadequate contraceptive measures Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction) Presence of any clinically significant laboratory anomaly Known cases of AIDS (HIV positive) History of Coronary Angioplasty/CABG within the past 2 years Moderate to severe peripheral neuropathy or other neurological disorders Alcohol abuse, medication or drug dependence Concurrent or previous participation in a clinical study within previous 6 weeks

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexsure Capsules<br>Investigational Product | Dietary Supplement: Flexsure Capsules<br>* Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days<br>* Other names: Paracetamol;|
| Placebo Comparator: Carboxy Methyl Cellulose Capsules<br>Placebo | Dietary Supplement: Placebo Capsules<br>* Carboxy Methyl Cellulose<br>* Other names: Paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC - pain subscale |  | 56 Days | 
| Clinical Adverse Events |  | 56 Days | 
| Laboratory Adverse Events |  | 56 Days | 
| Assessment of Tolerability by the Subject |  | 56 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale - Pain |  | 56 Days | 
| Consumption of Rescue Medication |  | 56 Days | 
| Investigator's and Subject's Global Assessment |  | 56 Days |