Osteoarthritis
Conditions
Brief summary
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTFlexsure Capsules
Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
DIETARY_SUPPLEMENTPlacebo Capsules
Carboxy Methyl Cellulose
Sponsors
VitalgNetics
Vedic Lifesciences Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Consumption of Rescue Medication | 56 Days |
| Investigator's and Subject's Global Assessment | 56 Days |
| Visual Analog Scale - Pain | 56 Days |
Countries
India
Outcome results
None listed