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A randomized interventional clinical trial assessing the safety and effectiveness of PeaNoc XL tablets in managing joint pain and inflammation in arthritis patients.
- Source :
-
F1000Research [F1000Res] 2023 Jul 27; Vol. 12, pp. 895. Date of Electronic Publication: 2023 Jul 27 (Print Publication: 2023). - Publication Year :
- 2023
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Abstract
- Background : Globally, alternative medicine is used widely by most patients for several health challenges. To evaluate the effectiveness and safety of PeaNoc XL Tablet in managing pain and inflammation, a randomized clinical trial and systematic study was designed. PeaNoc XL Tablet has been widely utilized for pain and inflammation management, but no previous studies have examined its efficacy and safety. The aim of this study was to determine the clinical effectiveness and safety profile of PeaNoc XL in patients with arthritis experiencing joint pain and inflammation. Methods : A randomized, controlled, and an open-label trial was conducted. A total of 155 patients (18 to 60 years) with arthritis were enrolled for participation. Using computer-generated random sequences, the study population was divided into two groups in a randomized manner. Group A received Standard therapy and Group B received Standard therapy with PeaNoc XL Tablet 400mg (two tablets OD after food). Results : Out of 155 patients, a total of 83 individuals were excluded from the study, leaving 72 patients who were randomly assigned to either Group A (n=36) or Group B (n=36). The administration of PeaNoc XL as an adjunct to standard therapy resulted in a significant reduction in levels of TNF-α (P<0.01), IL-1β (P<0.001), IL-6 (P<0.01), and CRP (P<0.01) in arthritis patients experiencing joint pain and inflammation. Conversely, no notable differences were observed from the baseline in the standard therapy group. Conclusions : After 12 weeks of supplementation of PeaNoc XL tablets, as an add-on therapy helps in the reduction of pain score, joint stiffness, and physical stiffness. Trial registration:  CTRI/2022/10/046693.<br />Competing Interests: Competing interests: Mr Nandakumar is Research Scholar SRM and Marketing Head at Apex Laboratories Private Ltd, who manufacture PeaNoc XL; Mr Caston E is Global Head of Fuji Chemicals Japan; Mr S. V. Vishagan is President and Director of Apex Laboratories Private Ltd; Mr Pankaj Negi is Regional Head of Fuji Chemicals and A. Sukkur is Vice President, Apex Laboratories Private Limited. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br /> (Copyright: © 2023 Kadanangode Narayanaswam N et al.)
Details
- Language :
- English
- ISSN :
- 2046-1402
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- F1000Research
- Publication Type :
- Academic Journal
- Accession number :
- 37767025
- Full Text :
- https://doi.org/10.12688/f1000research.138477.1