Cargando…
Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry
Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465020/ https://www.ncbi.nlm.nih.gov/pubmed/32751570 http://dx.doi.org/10.3390/brainsci10080499 |
_version_ | 1783577495595909120 |
---|---|
author | Kumar, Ramesh Abu Bakar, Azizi Thanabalan, Jegan Paramasvaran, Sanmugarajah Toh, Charng Jeng Jaffar, Ainul Fadzil, Farizal Kamalanathan, Palaniandy Soon, Bee Hong Venketasubramanian, Narayanaswamy |
author_facet | Kumar, Ramesh Abu Bakar, Azizi Thanabalan, Jegan Paramasvaran, Sanmugarajah Toh, Charng Jeng Jaffar, Ainul Fadzil, Farizal Kamalanathan, Palaniandy Soon, Bee Hong Venketasubramanian, Narayanaswamy |
author_sort | Kumar, Ramesh |
collection | PubMed |
description | Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH. Methods: The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT). Results: Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0–4, from 12% to 59% (p < 0.0001); GCS 13–15, from 64% to 88% (p = 0.007); mRS 0–1, from 9% to 37% (p = 0.004); and SOMCT score 0–8, from 44% to 68% (p = 0.029). Conclusions: NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH. |
format | Online Article Text |
id | pubmed-7465020 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-74650202020-09-04 Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry Kumar, Ramesh Abu Bakar, Azizi Thanabalan, Jegan Paramasvaran, Sanmugarajah Toh, Charng Jeng Jaffar, Ainul Fadzil, Farizal Kamalanathan, Palaniandy Soon, Bee Hong Venketasubramanian, Narayanaswamy Brain Sci Communication Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH. Methods: The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT). Results: Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0–4, from 12% to 59% (p < 0.0001); GCS 13–15, from 64% to 88% (p = 0.007); mRS 0–1, from 9% to 37% (p = 0.004); and SOMCT score 0–8, from 44% to 68% (p = 0.029). Conclusions: NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH. MDPI 2020-07-30 /pmc/articles/PMC7465020/ /pubmed/32751570 http://dx.doi.org/10.3390/brainsci10080499 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Communication Kumar, Ramesh Abu Bakar, Azizi Thanabalan, Jegan Paramasvaran, Sanmugarajah Toh, Charng Jeng Jaffar, Ainul Fadzil, Farizal Kamalanathan, Palaniandy Soon, Bee Hong Venketasubramanian, Narayanaswamy Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title | Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title_full | Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title_fullStr | Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title_full_unstemmed | Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title_short | Safety and Use of MLC601/MLC901 (NeuroAiD(TM)) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry |
title_sort | safety and use of mlc601/mlc901 (neuroaid(tm)) in primary intracerebral hemorrhage: a cohort study from the neuroaid safe treatment registry |
topic | Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465020/ https://www.ncbi.nlm.nih.gov/pubmed/32751570 http://dx.doi.org/10.3390/brainsci10080499 |
work_keys_str_mv | AT kumarramesh safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT abubakarazizi safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT thanabalanjegan safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT paramasvaransanmugarajah safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT tohcharngjeng safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT jaffarainul safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT fadzilfarizal safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT kamalanathanpalaniandy safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT soonbeehong safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry AT venketasubramaniannarayanaswamy safetyanduseofmlc601mlc901neuroaidtminprimaryintracerebralhemorrhageacohortstudyfromtheneuroaidsafetreatmentregistry |