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)
ambalikeclinic@gmail.com
2. Dr Ajay Kumar Mishra (public)
drakm1969@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mohan Mishra
ORCID ID
http://orcid.org/0000-0001-6764-2938
Contact details
Ambalike Clinic
Bengali Tola
Laheriasarai
Darbhanga
846001
India
+919431286913
ambalikeclinic@gmail.com
Type
Public
Additional contact
Dr Ajay Kumar Mishra
ORCID ID
Contact details
Ambalike Clinic
Bengali Tola
Laheriasarai
Darbhanga
846001
India
+919431857475
drakm1969@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P01/2015
Study information
Scientific title
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
Acronym
BITOD
Study hypothesis
Primary hypothesis:
Brahmi is useful in the treatment of dementias and helps reduce Global Deterioration Scale (GDS) score within three months
Secondary hypothesis
Treatment with Brahmi will lead to a reduction in age-related falls.
Ethics approval
Ambalike Clinic Institutional Ethics committee, 15/04/2015, ref: 01/2015
Study design
Interventional single-centre non-randomised single arm open-label trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Dementia
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
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
01/06/2015
Overall trial end date
31/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years and over
2. Diagnosis of dementia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. History of Intolerance or allergy to Brahmi
2. Type 1 Diabetes Mellitus
3. Pregnancy
Recruitment start date
01/06/2015
Recruitment end date
10/02/2016
Locations
Countries of recruitment
India
Trial participating centre
Ambalike Clinic
Bengali Tola, Laheriasarai
Darbhanga
846001
India
Funders
Funder type
Hospital/treatment centre
Funder name
Ambalike Clinic
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
31/07/2017
Participant level data
Not expected to be available
Results - basic reporting
See additional file ISRCTN18407424_BasicResults_26Sep16
Publication summary
Publication citations
Additional files
- ISRCTN18407424_BasicResults_26Sep16.docx Uploaded 05/10/2016