Dementia - an innovative treatment with Bacopa monnieri Linn
| ISRCTN | ISRCTN12595633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12595633 |
| Secondary identifying numbers | 01/2019 |
- Submission date
- 17/07/2019
- Registration date
- 22/07/2019
- Last edited
- 20/04/2020
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Ambalike Clinic, Bengalitola, Near Sharma Diagnostics, Laheriasarai
Darbhanga
846001
India
 ORCID ID |
0000-0001-6764-2938 |
|---|---|
| Phone | +91 (0)9431286913 |
| momishra2006@yahoo.co.in |
Public
Ambalike Clinic, Bengalitola, Near Sharma Diagnostics
Darbhanga
846004
India
| Phone | +91 (0)9431857475 |
|---|---|
| drakm1969@gmail.com |
Study information
| Study design | Interventional single-centre non-randomised single-arm open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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) |
| Study acronym | DITBM |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 25/05/2019 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Diagnosis of dementia |
| Key exclusion criteria | 1. History of intolerance or allergy to Brahmi 2. Type 1 diabetes mellitus 3. Pregnancy |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- India
Study participating centre
Near Sharma Diagnostics
Laheriasarai
Darbhanga
846001
India
Sponsor information
Hospital/treatment centre
Ambalike, Bengalitola, Near Sharma Diagnostics, Laheriasarai
Darbhanga
846001
India
| Phone | +91 (0)9431286913 |
|---|---|
| momishra2006@yahoo.co.in |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plan to publish in a high-impact peer-reviewed journal in the year 2024. |
| IPD sharing plan | 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. |
Editorial Notes
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
22/07/2019: Trial's existence confirmed by ethics committee.
