| CTRI Number |
CTRI/2026/02/104783 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic Treatment for Anxiety, Stress and Depression in Older Adults 65 years and above: Does It Support Successful Aging? |
|
Scientific Title of Study
|
Role of Homoeopathy in Promoting Resilient Aging in Geriatric Patients Positive on DASS 21 using Successful aging inventory (SAI): An Experimental Uncontrolled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Justina M Steefan |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Homoeopathic Medical College and hospital |
| Address |
Dr Justina M Steefan , Associate professor, department of psychiatry, Father Muller Homoeopathic Medical College and hospital, university road, Deralakatte, Karnataka Father Muller Homoeopathic Medical College and hospital, university road, Deralakatte, Karnataka Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8547964493 |
| Fax |
|
| Email |
drjustinasteefan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunita Nikumbh |
| Designation |
Professor, Head of the department |
| Affiliation |
MLDawale Memorial Homoeopathic Institute |
| Address |
Dr Sunita Nikumbh
PhD Guide and Head, Department of Psychiatry
Room No 301
ML Dawale Memorial Homoeopathic Institute, Palghar ML Dawale Memorial Homoeopathic Institute, Palghar 401404 Palghar MAHARASHTRA 401404 India |
| Phone |
7721076363 |
| Fax |
|
| Email |
sunita.nikumbh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Siddesha G |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Homoeopathic Medical College and hospital |
| Address |
Dr Siddesha G , Associate professor, department of psychiatry, Father Muller Homoeopathic Medical College and hospital, university road, Deralakatte, Karnataka Father Muller Homoeopathic Medical College and hospital, university road, Deralakatte, Karnataka Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8660861093 |
| Fax |
|
| Email |
drsiddesh009@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Justina M Steefan |
| Address |
Father Muller Homoeopathic Medical College and hospital,University road, deralakatte |
| Type of Sponsor |
Other [self] |
|
|
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 Sunita Nikumbh |
ML Dawale Memorial Homoeopathic Institute, Palghar |
Department of Psychiatry
Room No 301
MLDawale Memorial Homoeopathic Institute, Palghar 401404 Palghar MAHARASHTRA |
7721076363
sunita.nikumbh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MLDMHI, Palghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (2) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Treatment |
administration of homoeopathic remedies tailored specifically to the individuals symptoms and overall health condition. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are positive on DASS 21 scale (mild depression, mild anxiety and mild stress)
Patients who have any systemic illness as comorbidity. (they will be continuing the medications for the same)
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment – Patients who has score less than 24 in MMSE
Patients who are taking allopathic medications for any Psychiatric illness
Concurrent participation in other clinical trials involving interventions for anxiety, depression or stress
Those who are positive on DASS 21 but in moderate and severe categories of depression, anxiety and stress.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total score of the Successful Aging Inventory (SAI) following individualized homoeopathic treatment |
Screening and pre intervention assessments – 3 months
Intervention and post intervention assessments – 12 months
Data analysis and interpretation of the results – 3 months
Total duration – 1 year 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in domain-wise scores of the Successful Aging Inventory (SAI), including:
Functional Performance Mechanisms
Intrapsychic Factors
Spirituality
Gerotranscendence |
Screening and pre intervention assessments – 3 months
Intervention and post intervention assessments – 12 months
|
| Change in Depression, Anxiety, and Stress levels as measured by the Depression Anxiety Stress Scales–21 (DASS-21) |
Screening and pre intervention assessments – 3 months
Intervention and post intervention assessments – 12 months
|
|
|
Target Sample Size
|
Total Sample Size="37" Sample Size from India="37"
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)
|
01/04/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of individualized homoeopathic treatment in promoting healthy and resilient aging among geriatric patients aged 65 years and above who have elevated scores on the Depression Anxiety and Stress Scale 21. Psychological distress in the elderly is common and may negatively influence overall wellbeing functional ability and quality of life. A holistic intervention that addresses both psychological and adaptive dimensions of aging may support better health outcomes in this population. The primary objective of the study is to assess changes in healthy aging as measured by the Successful Aging Inventory. Secondary objectives include evaluating the effect of individualized homoeopathic treatment on specific domains of successful aging such as functional performance mechanisms intrapsychic factors spirituality and gerotranscendence. The study will also assess changes in depression anxiety and stress levels using the DASS 21 scale. This is an experimental uncontrolled study conducted in a homoeopathic medical college hospital and associated centers. Participants who meet the inclusion criteria will receive individualized homoeopathic treatment based on classical principles. Baseline assessments will be conducted using DASS 21 and the Successful Aging Inventory followed by periodic follow up assessments every three months for one year. The findings of this study are expected to provide evidence regarding the role of individualized homoeopathy in enhancing psychological wellbeing and promoting resilient aging in the geriatric population. |