Condition category
Mental and Behavioural Disorders
Date applied
17/07/2019
Date assigned
22/07/2019
Last edited
22/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Dementia is a major health problem of modern times. Billions of dollars have been poured in its research, but we are no better today than we were years ago. There are various forms of this condition; we have some inkling of their causes but when it comes to treatment we draw a blank. Alzheimer’s disease (AD) is the most serious form. Many researchers have hypothesized that if the progression of the milder forms could be slowed down they would not progress to full-fledged AD. But even this assumption may be just wishful thinking. In any case it is not known how to halt this progression, much less to cure it. Classical medicine says that we should first identify the causes and then try to treat it, but this approach may not always work. If a patient presents with high body temperature the physician tries to bring it down even if he is not sure of the cause – a definitive diagnosis can wait. Can we adopt this line of approach in dementias too? Forgetfulness is the cardinal feature of dementia – is it possible to reduce forgetfulness even before diagnosing the root cause? Brahmi is a herb used traditionally in India for a long time as a memory-enhancer, and could be useful in dementia. A pilot study (Brahmi (Bacopa Monnieri Linn) in the treatment of dementia} has shown that Brahmi can be very effective in dementia, irrespective of its type or grade (https://www.isrctn.com/ISRCTN18407424). This study is an extension of Phase II of that study.

Who can participate?
Patients aged 18 years and over with dementia

What does the study involve?
Every patient is given an extract of Brahmi (Himalaya) at a dose of 250 mg tablets twice daily orally for three months. Dementia progression is measured before the start of the treatment and again after three months of treatment. After the final evaluation at the end of three months, no further follow-ups are planned.

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 (Bacopa monnieri Linn), but this is very mild.

Where is the study run from?
Ambalike Clinic (India)

When is the study starting and how long is it expected to run for?
May 2019 to December 2022

Who is funding the study?
Ambalike Clinic (India)

Who is the main contact?
1. Prof. Mohan Mishra
momishra2006@yahoo.co.in
2. Dr Ajay Kumar Mishra
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
Bengalitola
Near Sharma Diagnostics
Laheriasarai
Darbhanga
846001
India
+91 (0)9431286913
momishra2006@yahoo.co.in

Type

Public

Additional contact

Dr Ajay Kumar Mishra

ORCID ID

Contact details

Ambalike Clinic
Bengalitola
Near Sharma Diagnostics
Darbhanga
846004
India
+91 (0)9431857475
drakm1969@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

01/2019

Study information

Scientific title

A Phase II 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 (GDS) and Standardized Mini-Mental State Examination (SMMSE)

Acronym

DITBM

Study hypothesis

Primary hypothesis:
Brahmi is useful in the treatment of dementia and helps improve Global Deterioration Scale (GDS) score and Standardized Mini-Mental State Examination (SMMSE) within three months

Secondary hypothesis:
Treatment with Brahmi will lead to a reduction in age-related falls.

Ethics approval

Approved 01/07/2019, Ambalike Clinic Institutional Ethics Committee (Ambalike Clinic, Near Sharma Diagnostics Bengalitola, Laheriasarai, Darbhanga, Bihar, Tel:- +91 (0)9431857477; Email: rashmipriyamishra2009@gmail.com), ref: 01/2019

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 will be administered an extract of Brahmi (Himalaya) at a dose of 250 mg tablets twice daily orally for three months. The GDS and SMMSE will be determined before the start of the treatment and again after three months of treatment. After the final evaluation at the end of three months, no further follow-ups are planned.

Intervention type

Drug

Phase

Phase II

Drug names

Brahmi (Bacopa monnieri Linn)

Primary outcome measure

Dementia progression measured using the Global Deterioration Scale (GDS) and Standardized Mini-Mental State Examination (SMMSE) at baseline and at the end of 3 months

Secondary outcome measures

Age-related falls measured through self-reporting by patients and/or their attendants at baseline and after 1 and 3 months

Overall trial start date

25/05/2019

Overall trial end date

30/12/2022

Reason abandoned (if study stopped)

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

60

Participant exclusion criteria

1. History of intolerance or allergy to Brahmi
2. Type 1 diabetes mellitus
3. Pregnancy

Recruitment start date

01/08/2019

Recruitment end date

31/07/2022

Locations

Countries of recruitment

India

Trial participating centre

Ambalike Clinic
Bengalitola Near Sharma Diagnostics Laheriasarai
Darbhanga
846001
India

Sponsor information

Organisation

Ambalike Clinic

Sponsor details

Ambalike
Bengalitola
Near Sharma Diagnostics
Laheriasarai
Darbhanga
846001
India
+91 (0)9431286913
momishra2006@yahoo.co.in

Sponsor type

Hospital/treatment centre

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

Plan to publish in a high-impact peer-reviewed journal in the year 2024.

IPD sharing statement
The datasets will be available at the end of the study from Dr Ajay Kumar Mishra (drakm1969@gmail.com, momishra2006@yhoo.co.in). The data will be anonymised taking care of ethical and legal restrictions. The details, including the types of analyses, will be explained at that time. Written informed consent will be obtained in every case. The researchers hope to keep the data for five years after the end of the study.

Intention to publish date

31/12/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/07/2019: Trial's existence confirmed by ethics committee.