Original Research Article
Year: 2020 | Month: January-March | Volume: 5 | Issue: 1 | Pages: 1-5
Efficacy and Safety of Nutraceutical Composition Mobileye® Capsules in Improving Synovial Joint Health in Indian Population
Dharmeshkumar B Kheni, Varun P Sureja, Divyanshu G Prajapati, Mayank P Rajawat, Ajit D Magar
Department of Medical Affairs, SundyotaNumandis Group of Companies, Ahmedabad
Corresponding Author: Dharmeshkumar B Kheni
ABSTRACT
Background: Osteoarthritis (OA); a whole joint disorder is a most common and progressive disease that worsens with age. Synovitis and synovial effusion can play important role in early OA diagnosis and progression. Limited pharmacological interventions affecting synovial effusion are studied clinically in Indian population.
Aim: This was a pilot, observational, single arm, open label study in real world set-up designed to evaluate the efficacy and safety of Mobileye® capsules containing sodium hyaluronate along with collagen and polysaccharides derived from rooster comb extract in subjects suffering from synovial effusion and knee pain of osteoarthritis.
Materials and Method: The study was conducted on total 30 subjects at Outpatient Department (OPD) at three different sites under the supervision of medical doctor. All subjects consumed Mobileye® capsule orally twice daily for 3 months. Synovial effusion, VAS score, WOMAC score and safety parameters were assessed as scheduled.
Results: Treatment with Mobileye® capsule showed significant and progressive improvement in all study related parameters. Baseline score vs. day 90 score (mean + SD) for synovial effusion, WOMAC pain score, WOMAC stiffness score, WOMAC physical function score, WOMAC total score and VAS score were 8.52+2.960 mm vs. 2.58+0.903 mm (p<0.0001), 15.13+3.10 vs. 4.13+2.4 (p<0.0001), 6.63+1.098 vs. 1.60+1.192 (p<0.0001), 54.33+8.39 vs. 14.23+8.67 (p<0.0001), 76.13+ 11 vs. 20.33+ 10.86 and 8.13 + 1.28 vs. 1.93+1.17 (p<0.0001) respectively. No significant adverse events were reported.
Conclusion: Oral intake of Mobileye® capsule is safe and effective intervention in reducing synovial effusion, pain, stiffness and in improving joint mobility.
Keywords: Mobilee®, Mobileye®, Rooster Comb Extract, Hyaluronic acid, Synovial effusion