| CTRI Number |
CTRI/2025/12/099640 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Adaptation in End Stage Renal Disease care givers using the Roy Adaptation Model and Caregivers Burden Inventory and it’s Homeopathic Management: An uncontrolled experimental study in Palghar District,Maharashtra. |
|
Scientific Title of Study
|
Assessing Adaptation in End Stage Renal Disease care givers using the Roy Adaptation Model and Caregivers Burden Inventory and it’s Homeopathic Management: An uncontrolled experimental study in Palghar District,Maharashtra. |
| 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 Mansi Surati |
| Designation |
Asst Professor |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Instittute |
| Address |
Dr Mansi Surati
Dept of Psychiatry, Dr M.L.Dhawale Memorial Homoeopathic Institute,
Opp ST workshop, Palghar- Boisar Road, Palghar, Maharashtra
Palghar
MAHARASHTRA
401404
India |
| Phone |
7757915119 |
| Fax |
|
| Email |
mansi.surati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Surati |
| Designation |
Asst Professor |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Instittute |
| Address |
Dr Mansi Surati
Dept of Psychiatry, Dr M.L.Dhawale Memorial Homoeopathic Institute,
Opp ST workshop, Palghar- Boisar Road, Palghar, Maharashtra
Palghar
MAHARASHTRA
401404
India |
| Phone |
7757915119 |
| Fax |
|
| Email |
mansi.surati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Surati |
| Designation |
Asst Professor |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Instittute |
| Address |
Dr Mansi Surati
Dept of Psychiatry, Dr M.L.Dhawale Memorial Homoeopathic Institute,
Opp ST workshop, Palghar- Boisar Road, Palghar, Maharashtra
Palghar
MAHARASHTRA
401404
India |
| Phone |
7757915119 |
| Fax |
|
| Email |
mansi.surati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. M L Dhawale Homoepathic Medical college, Palhar 401404, Maharashtra, India
Dr Mansi Surati ( Self) |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Shop 9, Dr Mansi Surati Clinic, Telephone Exchange Lane, Shimpoli, Borivali- 400092, Mumbai, Maharashtra, India |
| Type of Sponsor |
Other [] |
|
|
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 Mansi Surati |
Dr M L Dhawale Memorial Homoeopathic Instittute |
Dialysis Department, Room 142
Palghar
MAHARASHTRA |
07757915119
mansi.surati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr.M.L.Dhawale Memorial Homoepathic Institute, Palghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F438||Other reactions to severe stress, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Treatment |
Individualized Homeopathic remedy in potency 30,200 or 1M OR 50 Millicimal, based on detailed case taking and assessment using Roy Adaptation Model. Medicine will be selected as per homeopathic principles. The intervention will be continued for study duration with specific period follow ups assessments using care givers burden inventory and Roy Adaptation Model. |
| Comparator Agent |
Not applicable |
This is an uncontrolled experimental study with no comparator arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Caregiver of an individual diagnosed with End-Stage Renal Disease (ESRD) who is receiving dialysis within Palghar District, Maharashtra.
-Provide care for the ESRD patient for a minimum of 3 months prior to enrollment in the study.
-Care givers undergoing yoga or any natural therapy ( scoring above 24)
-Scoring above 24 on CBI Scale
|
|
| ExclusionCriteria |
| Details |
-Caregivers working in healthcare field or paid workers
-Pregnant caregivers, due to hormonal influences on mental and physical health
-Caregivers not consuming homoeopathic medicines as per prescribed repetition
-Care givers of more than 1 patient
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the impact of individualized homeopathic treatment on caregiver burden and adaptation levels of RAM in ESRD caregivers. |
Baseline at 6months of interventions, intermediate at 12 months and post at 18 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)
|
01/01/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
12 cases were screened and CBI was applied.
8 of them crossed cut off score. All 8 cases were defined. Stages of Adaptation as per Roy Adaptation model was identified. All were given Homeopathic constitutional remedy was given. Subsequent follow ups were be documented and intermediate scale application will be done and more cases will be recruited |