A Study for Moderate Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

— Flexsure  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478997
• Other study ID #: SA/110114/FLX/OA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2011
• Last updated: May 15, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• Placebo Capsules
Carboxy Methyl Cellulose

Locations

Country	Name	City	State
India	Nasik	Nasik	Maharashtra
India	Pune	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.	VitalgNetics

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC - pain subscale		56 Days	No
Primary	Clinical Adverse Events		56 Days	Yes
Primary	Laboratory Adverse Events		56 Days	Yes
Primary	Assessment of Tolerability by the Subject		56 Days	Yes
Secondary	Visual Analog Scale - Pain		56 Days	No
Secondary	Consumption of Rescue Medication		56 Days	No
Secondary	Investigator's and Subject's Global Assessment		56 Days	No