A Study for Moderate Osteoarthritis of the Knee

NCT ID: NCT01478997

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-03-31

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

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Flexsure Capsules

Investigational Product

Group Type: EXPERIMENTAL

Flexsure Capsules

Intervention Type: DIETARY_SUPPLEMENT

Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days

Carboxy Methyl Cellulose Capsules

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type: DIETARY_SUPPLEMENT

Carboxy Methyl Cellulose

Interventions

Flexsure Capsules

Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo Capsules

Carboxy Methyl Cellulose

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Paracetamol; Paracetamol

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VitalgNetics

UNKNOWN

Sponsor Role: collaborator

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Bhakti Shinde, BAMS, PGDCR

Role: STUDY_CHAIR

Vedic Lifesciences Pvt. Ltd.

Locations

Nasik

Nashik, Maharashtra, India

Pune

Pune, Maharashtra, India

Countries

India

Other Identifiers

SA/110114/FLX/OA

Identifier Type: -

Identifier Source: org_study_id