| CTRI Number |
CTRI/2025/09/095340 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Quality of Life in Dementia with Individualised Homoeopathic Medicines
|
|
Scientific Title of Study
|
The role of individualised homoeopathic medicines in improving the quality of life in dementia
|
| 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 KALAIYARASI P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Practice of Medicine
White memorial homoeo medical college,
Attoor, Veeyanoor ,kanniyakumari
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
7397583249 |
| Fax |
|
| Email |
kalaipalanivel159@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR PRIYA RAJINI RM |
| Designation |
HEAD OF THE DEPARTMENT OF PRACTICE OF MEDICINE |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL, ATTOOR VEEYANOOR POST KANNIYAKUMARI TAMILNADU Kanniyakumari TAMIL NADU 629177 India |
| Phone |
7598188279 |
| Fax |
|
| Email |
drpriyarm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR PRIYA RAJINI RM |
| Designation |
HEAD OF THE DEPARTMENT OF PRACTICE OF MEDICINE |
| Affiliation |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL, ATTOOR, VEEYANOOR POST, KANIYAKUMARI TAMILNADU
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
7598188279 |
| Fax |
|
| Email |
drpriyarm@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PRACTICE OF MEDICINE
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ,ATTOOR, VEEYANOOR POST ,KANNIYAKUMARI DIST TAMILNADU 629177
|
|
|
Primary Sponsor
|
| Name |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
ATTOOR ,VEEYANOOR POST,KANNIYAKUMARI DIST TAMILNADU 629177 |
| Type of Sponsor |
Private 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 KALAIYARASI P |
White Memorial Homoeo Medical College and Hospital |
Department of Practice Of Medicine White Memorial Homoeo Medical College and Hospital Attoor, Veeyanoor.
Kanniyakumari
TAMIL NADU Kanniyakumari TAMIL NADU |
7397583249
kalaipalanivel159@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F039||Unspecified dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines |
The individualised homoeopathic medicine will be prescribed with proper dose, potency (30C/200C/1M).follow up will be taken once in a month and homoeopathic medicine will be prescribed fopr one month according to patient symptom.Quality of life in dementia patients should be assessed three months once by using DEMQOL Scale .The duration of study is 1 year |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
46.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age of the patient above 45 years.
Confirmed cases of dementia through Montreal Cognitive assessment.
Patient having MoCA score above 10 to 25.
|
|
| ExclusionCriteria |
| Details |
Patients having other neurological disorders like Alzheimer disease, Parkinsons disease.
Patients having other psychiatric illness like, Bipolar disorder, Schizophrenia etc.
Patients under allopathic medication such as anticholinergic and antipsychotic drugs
Patients having serious systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of life will be assessed by using Dementia Quality of Life.
Maximum score- 112
From baseline score: 1 to 9 score increases - Mild improvement.
10–19 score increases - Moderate improvement.
More than 20 score increases - Marked improvement |
3 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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kalaipalanivel159@gmail.com].
- For how long will this data be available start date provided 13-11-2026 and end date provided 13-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
AIM:
To evaluate the effectiveness of individualized Homoeopathic
medicines in improving the quality of life in dementia patients.
OBJECTIVES
To assess the impact of individualized Homoeopathic medicine
on the quality of life in dementia patients.
To measure the changes in memory, emotional wellbeing, daily
activities using DEMQOL questionnaire before and after treatment
To identify the most used Homoeopathic medicines for
dementia BACKGROUND AND JUSTIFICATION
Dementia is a progressive neurodegenerative disorder marked
by a decline in cognitive function, memory, language, and the ability to
perform everyday activities. It primarily affects the elderly population and is
associated with a significant deterioration in quality of life both for
the individual and their caregivers .Despite the availability of conventional pharmacological
treatments, these often provide only symptomatic relief and are frequently
accompanied by side effects, especially in elderly individuals with multiple
comorbidities. While there is small scale studies have reported improvement
in symptoms and over all wellbeing in dementia patients using individualized
homoeopathic medicine, there is a lack of structured clinical evidence
evaluating its impact on quality of life using validated scale like DEMQOL. This
study aim to play a role on improving overall wellbeing in dementia patients. METHODOLOGY The study will
be conducted with clinically diagnosed 40 cases of dementia will be selected
based on inclusion and exclusion criteria for the study. Diagnostic
screening will be done by Montreal Cognitive Assessment. The cases will be analyzed and
the totality of symptoms will be erected based on Homoeopathic philosophy to
arrive the suitable remedy for each patient. Then the
individualized Homoeopathic medicine will be prescribed with the proper dose,
potency, and repetitions. Follow up will be taken once
in a month to assess the improvement in quality of life among dementia
patients. Pre assessment and post
assessment of Dementia Quality of Life DEMQOL will be taken three months once
to evaluate the quality of life in dementia patients.
|