A Study for Moderate Osteoarthritis of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Dietary Supplement: Flexsure CapsulesDietary Supplement: Placebo Capsules
- Registration Number
- NCT01478997
- Lead Sponsor
- Vedic Lifesciences Pvt. Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flexsure Capsules Flexsure Capsules Investigational Product Carboxy Methyl Cellulose Capsules Placebo Capsules Placebo
- Primary Outcome Measures
Name Time Method Laboratory Adverse Events 56 Days Assessment of Tolerability by the Subject 56 Days WOMAC - pain subscale 56 Days Clinical Adverse Events 56 Days
- Secondary Outcome Measures
Name Time Method Visual Analog Scale - Pain 56 Days Consumption of Rescue Medication 56 Days Investigator's and Subject's Global Assessment 56 Days
Trial Locations
- Locations (2)
Pune
🇮🇳Pune, Maharashtra, India
Nasik
🇮🇳Nasik, Maharashtra, India