I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. The study was registered in Clinical trials registry of India, CTRI/2097 and approved by Universal Ethics Committee (A Unit of Aurous HealthCare Research and Development India Pvt. The details of the IRB/oversight body that provided approval or exemption for the research described are given below: I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. This study did not receive any funding Author Declarations
Competing Interest StatementĪuthor Samuel Abraham is a shareholder in GN Corporation, Japan which holds shares of Sophy Inc., Japan., the manufacturers of novel beta glucans using different strains of Aureobasidium pullulans a board member in both the companies and also an inventor to several patents of relevance to these beta glucans. Immunological parameters like NLR, LCR, LeCR correlating with clinical improvement, in line with earlier reports using the same beta-glucans, gain further significance for their potentials as biomarkers in MS. pullulans produced B-Glucan food supplement and the efficacy by improvement in the EDSS score, besides beneficial modulation of inflammation and immune parameters of relevance in MS patients in a short duration of 60 days, has significant potential as a disease modifying adjuvant in MS. Conclusion This study having proven the safety of N-163 strain of A.
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