Plain English Summary
Background and study aims
People are living longer than ever before and the incidence of Alzheimer’s disease (AD) and other age-related dementias continues to increase worldwide; no treatment is available to reverse or even at least to halt satisfactorily the underlying pathology of established AD. The objective/aim of the study was to determine whether an extract of Brahmi (Bacopa monnieri Linn) could be useful in different types of dementia. Brahmi (Bacopa monnieri Linn) is a herb used traditionally in India as a memory-enhancer. We studied its effect on human memory and forgetfulness in dementia of various grades - from mild to severe. There are reports of its efficacy in various publications: Many relate to its effect in animals, some to its effect in human beings too. One such study showed that it decreased the rate of forgetting newly acquired information in humans while the rate of learning remained unaffected. None of the reports specifically mentions its effect in dementias. We decided to conduct a pilot study, thus laying the framework for definitive studies.
Who can participate?
Patients with dementia over the age of 18.
What does the study involve?
All participants are given Brahmi (Himalaya) 250 mg to take twice a day for three months. Before starting treatment and then after three months, participants complete a number of questionnaires in order to find out how bad their AD is, and if they have experienced any falls.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their cognitive function, especially their memory. There is a small risk of experiencing bloating after taking Brahmi, but this is very mild.
Where is the study run from?
Ambalike Clinic (India)
When is study starting and how long is it expected to run for?
June 2015 to May 2016
Who is funding the study?
Ambalike Clinic (India)
Who is the main contact?
1. Professor Mohan Mishra (scientific)
2. Dr Ajay Kumar Mishra (public)
Prof Mohan Mishra
Dr Ajay Kumar Mishra
A pilot study on the effect of Brahmi (Bacopa Monnieri Linn) in various types and grades of dementia by comparing the effect of the drug on the participants using the Global Deterioration Scale
Brahmi is useful in the treatment of dementias and helps reduce Global Deterioration Scale (GDS) score within three months
Treatment with Brahmi will lead to a reduction in age-related falls.
Ambalike Clinic Institutional Ethics committee, 15/04/2015, ref: 01/2015
Interventional single-centre non-randomised single arm open-label trial
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Every patient is administered the extract of Brahmi (Himalaya) in the dose of 250 mg capsules twice daily orally for three months. The GDS was determined before the start of the treatment and again after three months. After the final evaluation at the end of three months no further follow ups are planned.
Brahmi (Bacopa Monnieri Linn)
Primary outcome measures
Alzheimer's progression is measured using the Global Deterioration Scale (GDS) at baseline and 3 months.
Secondary outcome measures
Age-related falls are measured through self-reporting by patients and/or their attendants at baseline, 1 and 3 months.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Aged 18 years and over
2. Diagnosis of dementia
Target number of participants
Participant exclusion criteria
1. History of Intolerance or allergy to Brahmi
2. Type 1 Diabetes Mellitus
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Bengali Tola, Laheriasarai
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of study results in a reputable journal by the end of 2016.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
See additional file ISRCTN18407424_BasicResults_26Sep16
- ISRCTN18407424_BasicResults_26Sep16.docx Uploaded 05/10/2016