A Study for Moderate Osteoarthritis of the Knee (Flexsure)

Vedic Lifesciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Osteoarthritis

Treatments

Dietary Supplement: Placebo Capsules

Dietary Supplement: Flexsure Capsules

Study type

Interventional

Funder types

Industry

Other

Identifiers

SA/110114/FLX/OA

Details and patient eligibility

About

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

Full 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

Enrollment

76 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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