Abstract
EVALUATION OF THE EFFICACY AND SAFETY OF NRL/2019/JC CAPSULES IN KNEE OSTEOARTHRITIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CROSSOVER CLINICAL STUDY

Dr. Omkar Kulkarni*, Dr. Anuj Agarwal, Priya Khare and Dr. Gayatri Ganu

ABSTRACT

Background: Osteoarthritis (OA) is a long-term chronic disease with deterioration of cartilage in joints which results stiffness, pain, and impaired movement. The most commonly prone joints are in the knees, hands, feet, and spine and is relatively common in knee and hip joints. Nutraceuticals developed for use in osteoarthritis have a role in the balance of anabolic and catabolic signals in joints. The antioxidant, anti-inflammatory and disease modifying capacity of nutraceutical blend can be considered for the management and prevention of osteoarthritis (OA). Methodology: The present clinical study was conducted in 101 subjects suffering from osteoarthritis of Knee(s). All the recruited subjects were provided with either placebo or NRL/2019/JC capsule for the period of 60 days and crossed over for 1 month i.e. till day 90. Subjects were asked to visit the study site every 30 days and changes in knee joint pain, stiffness, swelling, inflammatory markers, use of analgesic drug as rescue medicine, and quality of life of the subjects were assessed on every follow up visit. Results: After treatment with test drug, significant improvement in morning stiffness is observed from day 30 onwards and at the end of the study 12 (24%) subjects reported no morning stiffness while 38 (76%) reported mild morning stiffness. In test treated groups 87.5% subjects were dependent on analgesic as rescue medication which reduced significantly (P < 0.05) to 20% at day 60 in test group. There was significant reduction in pain in test treated group at day 60 from baseline. After day 60, placebo offered similar levels of markers but test treated group exhibited significant reduction in CRP and IL-6 levels with p<0.05. Conclusion: In the present study, use of NRL/2019/JC capsule in subjects suffering from OA is proved to be safe and effective. NRL/2019/JC capsule is significantly effective in reducing pain, swelling and stiffness of knee joint in subjects as well as in improving mobility of knee joints and quality of life. NRL/2019/JC capsule reduces elevated inflammatory cytokines thus confirms its anti-inflammatory activity. NRL/2019/JC capsule treatment led to reduction in dependency over NSAIDS as rescue medication.

Keywords: Osteoarthritis, nutraceutical, WOMAC, inflammation.


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