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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kalaipalanivel159@gmail.com].

  6. 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.

  7. 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.

 


 
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