| CTRI Number |
CTRI/2024/06/069112 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Vitamin B12 and Folic acid in cognition of patients with Dementia |
|
Scientific Title of Study
|
Role of combined therapy of Vitamin B-12 and Folic acid in cognition of elderly dementia patients in a tertiary care hospital in Eastern India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. (Dr.) Lopamudra (Dhar) Chowdhury |
| Designation |
Professor in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433135767 |
| Fax |
|
| Email |
drlopamudra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary support. Medicines will be provided free of cost to the study group from the hospital supply of R.G. Kar Medical College and Hospital, 1, Khudiram Bose Sarani, Kolkata-700004. |
|
|
Primary Sponsor
|
| Name |
R.G. Kar Medical College and Hospital |
| Address |
1, Khudiram Bose Sarani, Kolkata-700004. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Susmita Patwary |
Psychiatry Out Patient Department (Room no 404 of OPD Building) |
R. G. Kar Medical College and Hospital, Kolkata-700004.
Kolkata
WEST BENGAL |
9831138264
patwary.susmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, R. G. Kar Medical College and Hospital, Kolkata-700004 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Elderly people aged more than 60 years.
2) Both male and female.
3) Mentally healthy patients complaining of forgetfulness in daily life activities.
|
|
| ExclusionCriteria |
| Details |
1) Patients with H/O stroke, seizures.
2) Patients with psychiatric disorders.
3) Patients with history of head injury.
4) Known cases of neurological disorders.
5) Patients who are alcoholic or drug addict.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive assessment scores improvement |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life improvement |
6months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a longitudinal observational study to be conducted in Psychiatry Outdoor and the Department of Pharmacology of R.G Kar Medical College where 40 patients will be recruited above age of 60years and had been showing forgetfulness in daily life activities. Their baseline dementia scores will be assessed using Addenbrooke’s cognitive examination scale and Blessed Dementia Scale during first time registration. After the baseline cognitive assessment, combined therapy with Vitamin B-12 1.5mg and folic acid 5mg will be advised everyday for 6months. Next follow up will be done after 6months and the cognitive assessment scores will be checked again. The same medicines will be advised again for 6months. Final follow up will be done after next 6months in the same way. Then it will be seen whether there is change in Cognitive assessment scores from baseline and first follow up to the final follow up , with the combined therapy of Vitamin B-12 1.5mg and Folic acid 5mg. It is expected that there will be in improvement of cognition in these patients and it will improve their quality of life. |