Effect Of E-OA-07 On Improving Joint Health And Mobility In Individuals With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Received 16 September 2019
Accepted for publication 19 October 2019
Published 18 December 2019 Volume 2019:12 Pages 3365—3379
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Michael A Überall
Shalini Srivastava,1 Jayesh A Chaudhary,2 Robert N Girandola3
1Department of Clinical Development, Enovate Biolife, Mumbai, Maharashtra, India; 2Vedic Lifesciences, Mumbai, Maharashtra, India; 3Department of Human Biology, University of Southern California, Los Angeles, CA, USA
Correspondence: Shalini Srivastava
Enovate Biolife, 203, Morya Landmark, New Link Road, Andheri West, Mumbai, Maharashtra 400053, India
Aim: The aim of the present study was to evaluate the effect of E-OA-07 on individuals having osteoarthritis of the knee.
Background: Lanconone® (E-OA-07) is a widely marketed dietary supplement which has been previously studied in different clinical settings for managing chronic joint pain. This was a confirmatory study planned at a lowered dose regimen with the purpose of improving compliance and reducing consumer cost.
Methods: Male and female participants aged between 40 and 65 years, with history of joint pain for at least 3 years, were recruited. Knee joint dysfunction of grade II/III was radiographically characterized as per Kellgren-Lawrence system of classification. Enrolled participants were randomized to receive E-OA-07 at a dose of 1000 mg/day or placebo over a period of 8 weeks. The primary efficacy parameter was assessment of change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Whereas, the secondary parameters explored in the study included WOMAC subscales of stiffness and physical function, EQ-5D-5L questionnaire, systemic inflammatory marker (hs-CRP) and self-assessment of treatment satisfaction.
Results: At the end of 8 weeks, joint pain severity as per WOMAC was found to be significantly reduced in the E-OA-07 group as compared to placebo (p<0.001). Similar improvement was observed in the subscales of stiffness and physical function which corresponds to significant improvement in the quality-of-life standards of E-OA-07 participants (p<0.001), reporting higher treatment satisfaction (p<0.001).
Conclusion: E-OA-07 at a dose of 1000 mg/day was able to significantly reduce joint pain and thereby improve joint mobility in study participants. At the end of the study period, there was a clinically relevant change of 45.55%, 45.91% and 38.19% for pain, stiffness and physical function, respectively. Moving forward, studies could be planned for understanding the cartilage regenerative properties of E-OA-07.
Keywords: joint pain, joint inflammation, WOMAC, dietary supplement, osteoarthritis, Boswellia serrata
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