Brain Injury and NeuroAid Supplementation

For a patient who has experienced mild or moderate brain injury, will NeuroAid II as compared to placebo improve functioning?

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000711718

Acronym

BRAINS (BRAin Injury and NeuroAid Supplementation)

Enrollment

Registered

2013-06-28

Start date

2014-07-01

Completion date

2016-07-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many people who have had a traumatic brain injury experience cognitive and functional difficulties that can have a significant impact on their ability to return to everyday life (such as returning to employment and maintaining social relationship). NeuroAid is a herbal supplement that has been shown to improve neurological deficits in people who have experienced a stroke. This pilot clinical trial will examine if NeuroAid shows trends in cognitive and functional improvement in 140 people who have experienced a mild or moderate traumatic brain injury in the last 1 to 3 months as compared to a placebo control group (inactive capsule). Participants will be given either NeuroAid II or placebo to take 3x daily for 6 months. Participants will be asked to complete a computerised cognitive test and questionnaires about their symptoms, mood and quality of life. These assessments will be carried out before, during and after participants have taken their treatment so that we can compare the results between the two groups.

Interventions

NeuroAid II (MLC901) which contains 9 herbal components (Radix astragali, Radix salvia miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinesis, Carthamus tinctorius, Prunus persica, Radix polygalae and Rhizoma acori tatarinowii). The dose is standard at 2 capsules (0.4g/capsule) 3x/day by oral administration for 6 months. Adherence will be measured through counting the number of capsules not taken by the participant at each follow-up assessment

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Aged 18-65 years 1-12 months post-TBI Ability to provide informed consent Experiencing cognitive impairment following injury

Exclusion criteria

Pre-Brain injury disability Severe brain injury Co-existing severe comorbidity Current participation in another clinical trial Pregnancy (suspected or confirmed) Breast- feeding Not fluent in English or have aphasia Unknown date of injury Known allergy to NeuroAid or its component ingredients

Outcome results