The NeuroAiD Safe Treatment (NeST) Registry: A protocol

Narayanaswamy Venketasubramanian, Ramesh Kumar Athi Kumar, Lyna Soertidewi, Azizi Abu Bakar, Carine Laik, Robert Gan

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Article numbere009866
JournalBMJ Open
Volume5
Issue number11
DOIs
Publication statusPublished - 2015

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Registries
Therapeutics
Ethics Committees
Malaysia
Safety
Neuroaid
Indonesia
Medication Adherence
Information Storage and Retrieval
Biological Products
Ethics
Sample Size
Brain Injuries
Compliance
Appointments and Schedules
Demography
Physicians
Brain

ASJC Scopus subject areas

  • Medicine(all)

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The NeuroAiD Safe Treatment (NeST) Registry : A protocol. / Venketasubramanian, Narayanaswamy; Athi Kumar, Ramesh Kumar; Soertidewi, Lyna; Abu Bakar, Azizi; Laik, Carine; Gan, Robert.

In: BMJ Open, Vol. 5, No. 11, e009866, 2015.

Research output: Contribution to journalArticle

Venketasubramanian, N, Athi Kumar, RK, Soertidewi, L, Abu Bakar, A, Laik, C & Gan, R 2015, 'The NeuroAiD Safe Treatment (NeST) Registry: A protocol', BMJ Open, vol. 5, no. 11, e009866. https://doi.org/10.1136/bmjopen-2015-009866
Venketasubramanian, Narayanaswamy ; Athi Kumar, Ramesh Kumar ; Soertidewi, Lyna ; Abu Bakar, Azizi ; Laik, Carine ; Gan, Robert. / The NeuroAiD Safe Treatment (NeST) Registry : A protocol. In: BMJ Open. 2015 ; Vol. 5, No. 11.
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