Condition category
Mental and Behavioural Disorders
Date applied
04/09/2016
Date assigned
08/09/2016
Last edited
05/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Ambalike Clinic

Sponsor details

Bengali Tol
Laheriasarai
Darbhanga
846001
India

Sponsor type

Not defined

Website

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

Editorial Notes

05/10/2016: Results summary uploaded.