| CTRI Number |
CTRI/2024/03/064583 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Individualised Homoeopathic medicine in cases of Dementia |
|
Scientific Title of Study
|
Role of Individualised Homoeopathic Medicine in cases of Dementia in the age group of 50-80 years based on Kent’s Repertory: An Open Label Observational Clinical Study |
| 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 Rajdeep Saha |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case Taking & Repertory, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake,
North 24 PGS, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003797968 |
| Fax |
|
| Email |
rjpsaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case Taking & Repertory, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake,
North 24 PGS, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case Taking & Repertory, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake,
North 24 PGS, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector 3, Saltlake, Kolkata- 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
OPD No. 10, Department of case taking and Repertory, Block GE,
Sector 3, Saltlake, Kolkata 700106 |
| 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 Rajdeep Saha |
National institute of Homoeopathy |
OPD No. 10,
Department of Case
taking and Repertory,
Block GE, Sector 3,
Saltlake, Kolkata
700106
North Twentyfour Parganas
WEST BENGAL |
7003797968
rjpsaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F015||Vascular dementia, (2) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, (3) ICD-10 Condition: F039||Unspecified dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individulised Homoeopathic Medicine |
a)Cognitive function of patient will be first assessed at 1st Visit i.e. baseline using MoCA test b) Individualised Homoeopathic Medicine will be selected based on Kents Repertory.
b)Remedies selected will be prescribed in in centesimal or fifty-millesimal potencies, as decided appropriate to the case or condition.
c) Oral medication will be given
d) Again patients cognitive function will be assesssed using MoCA test after 6 months
e) Overall duration period for the study is 18 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having symptoms of dementia.
2. Patient willing to participate in the study after submitting their written informed consent forms.
3. Patient of both gender and all religion.
4. Patient belonging to age group of 50 to 80 years.
5. Patient must know either of the 3 languages- Bengali, Hindi or English.
6. Lifesaving conventional drug therapies (e.g., antidiabetics, antihypertensives, thyroid drugs, etc.) for comorbidities under control, to be continued uninterrupted. |
|
| ExclusionCriteria |
| Details |
1. Currently receiving homoeopathic treatment for any chronic condition(s).
2. Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life.
3. Uncontrolled, unevaluated, and/or complicated diabetes mellitus, hypertension, and other comorbidities; cases with other serious systemic unevaluated or uncontrolled diseases affecting quality of life.
4. Substance abuse and/or dependence.
5. Self-reported immune-compromised state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the change in the score of Montreal Cognitive Assessment (MoCA) over 6 months from baseline |
Baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
1. A minimum 40 samples would be chosen in this study suffering from Dementia. 2. Case taking of patients will be done as per standardized case recording proforma of National Institute of Homoeopathy, Kolkata. 3. Each case will be studied properly through evaluation of each and every symptom, and construction of a qualitative totality of symptoms. 4. Patients will receive individualised homoeopathic medicine after repertorisation from Kent’s Repertory. 5. Relevant investigations will be done as and when required. 6. Inclusion and exclusion criteria will be strictly maintained. 7. Each case will be assessed periodically to follow up the medicinal action through clinical assessment, expert opinion and relevant lab investigations. 8. Change in MoCA test will be recorded at base-line and after 6-months of the treatment |