The NeuroAiD Safe Treatment (NeST) Registry: a protocol.

Abstract

INTRODUCTION:

NeuroAiD (MLC601, MLC901), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. The NeuroAiD Safe Treatment (NeST) Registry aims to assess its use and safety in the real-world setting.

METHODS AND ANALYSIS:

The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information.

ETHICS AND DISSEMINATION:

Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements.

TRIAL REGISTRATION NUMBER:

NCT02536079.

• Authors: Narayanaswamy Venketasubramanian, Ramesh Kumar, Lyna Soertidewi, Azizi Abu Bakar, Carine Laik, Robert Gan
• Journal: BMJ open (BMJ Open) Vol. 5 Issue 11 Pg. e009866 (Nov 13 2015) ISSN: 2044-6055 [Electronic] England
• PMID: 26567259 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Chemical References

• Drugs, Chinese Herbal
• Neuroaid
• Neuroprotective Agents

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Brain (drug effects)
• Child
• Child, Preschool
• Drugs, Chinese Herbal (adverse effects, pharmacology)
• Female
• Humans
• Indonesia
• Infant
• Infant, Newborn
• Malaysia
• Male
• Middle Aged
• Neuroprotective Agents (adverse effects, pharmacology)
• Prospective Studies
• Recovery of Function (drug effects)
• Registries
• Research Design
• Stroke (drug therapy)
• Time Factors
• Treatment Outcome
• Young Adult