title: The NeuroAiD Safe Treatment (NeST) Registry: a protocol.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02536079.
authors.affiliation: Department of Neurology, Raffles Neuroscience Centre, Raffles Hospital, Singapore, Singapore.
authors.forename: Narayanaswamy
authors.initials: N
authors.lastname: Venketasubramanian
authors.affiliation: Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Kumar
authors.affiliation: Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia.
authors.forename: Lyna
authors.initials: L
authors.lastname: Soertidewi
authors.affiliation: Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
authors.forename: Azizi
authors.initials: A
authors.lastname: Abu Bakar
authors.affiliation: Moleac, Singapore, Singapore.
authors.forename: Carine
authors.initials: C
authors.lastname: Laik
authors.affiliation: Moleac, Singapore, Singapore.
authors.forename: Robert
authors.initials: R
authors.lastname: Gan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007214:Indonesia; D007223:Infant; D007231:Infant, Newborn; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D020127:Recovery of Function / Q000187:drug effects*; D012042:Registries; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018696:Neuroprotective Agents
keywords: CLINICAL PHARMACOLOGY; REHABILITATION MEDICINE; STATISTICS & RESEARCH METHODS; STROKE MEDICINE