| CTRI Number |
CTRI/2026/01/101098 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Application of homoeopathic treatment for Anxiety in elderly patients Assessed by DASS-21. |
|
Scientific Title of Study
|
Application of Synthesis Repertory (Radar Opus 3.3 Synthesis Treasure Edition) in managing Anxiety Expressions in the elderly, assessed by the Depression Anxiety Stress Scales - 21 Item version (DASS-21): A Pretest- Posttest Experimental 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 Anjali Vijay Patil |
| Designation |
Post Graduate Student |
| Affiliation |
Dr ML Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
316 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar-401 404.
Palghar
MAHARASHTRA
401404
India |
| Phone |
8652660345 |
| Fax |
|
| Email |
anjalipatil0409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikunj Jani |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
315 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar-401 404.
Palghar
MAHARASHTRA
401404
India |
| Phone |
9323180460 |
| Fax |
|
| Email |
drnikunj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikunj Jani |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
315 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar-401 404.
Palghar
MAHARASHTRA
401404
India |
| Phone |
9323180460 |
| Fax |
|
| Email |
drnikunj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. M L Dhawale Homoeopathic Memorial Trust Hospital, Palghar, Maharashtra 401404. |
|
|
Primary Sponsor
|
| Name |
Dr. M L Dhawale Memorial Trust Hospital, Palghar Research Institute and Hospital |
| Address |
DR M L Dhawale Memorial Homoeopathic Institute, Palghar-Boisar Road, Opp. S.T. Workshop, Palghar-401404, Dist. Palghar, Maharshtra, India |
| 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 Nikunj Jani |
Dr. M L Dhawale Memorial Homoeopathic Institute |
Boisar Road, Opp. S.T. Workshop, Palghar-401 404, Dist. Palghar, Maharashtra
Palghar
MAHARASHTRA |
9323180460
drnikunj@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: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated Homoeopathic medicine |
The homeopathic medicines will be procured from a GMP certified homoeopathic manufacturing company and the medicines will be dispensed from the homeopathic pharmacy of the mentioned study centre. The indicated homeopathic medicines will be prescribed in acute and chronic cases based on the totality repertorized from the Synthesis Repertory.
Dose- GLOBULES
Potency-30C, 200C, 1M or LM potency
Frequency- single dose to repeated dose at suitable interval depending on patient condition.
Route of administration- oral
Total duration of interval - 6 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients 60 and above 60 years
Patients of both sexes
Score indicating anxiety on DASS-21 scale from mild to severe (8 to 19 score)
|
|
| ExclusionCriteria |
| Details |
Severe psychiatric illness like cognitive impairment and dementia
Patients on Anti-psychotic anxiolytic medication for more than 1 year |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the action of indicated homeopathic medicine as per Synthesis Repertory in the management of anxiety expressions in the elderly using DASS-21 scale. |
0 month i.e. before treatment, after 3 months of treatment and after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enlist the rubrics which are not available in the Synthesis Repertory but are observed in the cases of anxiety expressions in elderly |
after 6 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
15/02/2026 |
| 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
|
As people age, they may experience many physical, physiological as well as emotional changes such as anxiety often increase but that not always recognised. There are various expressions of anxiety, such as palpitation, breathlessness, dryness of mouth, restlessness etc. The study focuses on the management of anxiety expressions using indicated homoeopathic medicine selected with the help of Synthesis repertory through Radar Opus 3.3. The changes in their anxiety levels are measured using the DASS 21 before and after treatment, to observe improvements and compare changes in the anxiety expressions of elderly. |