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Abstract
EFFICACY AND TOLERABILITY OF PROKNEE COLLAGEN IITM ON JOINT HEALTH IN INDIVIDUALS WITH MILD TO MODERATE JOINT PAIN: A RANDOMIZED, DOUBLE -BLIND, PLACEBO-CONTROLLED TRIAL
Shalini Srivastava*, Jiayou Li and Jianxing Yu
ABSTRACT
Osteoarthritis (OA) is a progressive joint disease resulting from degeneration of articular cartilage, thereby leading to a loss of joint function and debilitating pain. The present study aimed to investigate the effect of Proknee Collagen II™ on joint health and quality of life. A 12-week, randomized, double-blind, placebocontrolled, parallel study was conducted in participants with joint pain. Adults aged 40-65 years (n = 60) with joint pain diagnosed as Grade II knee OA were enrolled in the study and were randomized in a 1:1:1 ratio to receive either Proknee Collagen II™, Glucosamine hydrochloride (G) + Chondroitin sulfate (C), or placebo for 12-weeks. Improvement in the joint health was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Quality of life was assessed by the change in the EQ-5D-5L scores. At day 84, Proknee Collagen II™ demonstrated a statistically significant result in the joint health when compared to placebo (p=0.0021). Furthermore, Proknee Collagen IITM demonstrated a statistically significant change in the “usual activities” domain (p=0.0392) and in the “pain or discomfort” domain (p=0.0274) of the EQ-5D-5L questionnaire when compared to placebo at day 84. A statistically significant change was noted for the EQ-5D VAS scores in the Proknee Collagen IITM group (p=0.0081) when compared with placebo at day 84. Thus, Proknee Collagen IITM was able to significantly improve the joint health and quality of life of participants, and was well-tolerated.
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