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A Study for Moderate Osteoarthritis of the Knee (Flexsure)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01478997
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: Flexsure Capsules Dietary Supplement: Placebo Capsules Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Flexsure Capsules
Investigational Product
Dietary Supplement: Flexsure Capsules
Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
Other Name: Paracetamol
Placebo Comparator: Carboxy Methyl Cellulose Capsules
Dietary Supplement: Placebo Capsules
Carboxy Methyl Cellulose
Other Name: Paracetamol

Primary Outcome Measures :
  1. WOMAC - pain subscale [ Time Frame: 56 Days ]
  2. Clinical Adverse Events [ Time Frame: 56 Days ]
  3. Laboratory Adverse Events [ Time Frame: 56 Days ]
  4. Assessment of Tolerability by the Subject [ Time Frame: 56 Days ]

Secondary Outcome Measures :
  1. Visual Analog Scale - Pain [ Time Frame: 56 Days ]
  2. Consumption of Rescue Medication [ Time Frame: 56 Days ]
  3. Investigator's and Subject's Global Assessment [ Time Frame: 56 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478997

Nasik, Maharashtra, India, 422002
Pune, Maharashtra, India, 411004
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
Study Chair: Dr. Bhakti Shinde, BAMS, PGDCR Vedic Lifesciences Pvt. Ltd.

Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01478997     History of Changes
Other Study ID Numbers: SA/110114/FLX/OA
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs