NCT01478997

A Study for Moderate Osteoarthritis of the Knee

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Placebo Capsules	Carboxy Methyl Cellulose

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-11-24
• Last updated: 2012-05-16

Locations

2 sites across 1 country: India