| CTRI Number |
CTRI/2023/05/052894 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Mental Health of Care givers of CKD patients on hemodialysis of Palghar District |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic medicines in management of stresses and adaptive mechanism of care givers of CKD patients on haemo-dialysis through COPE INVENTORY An Experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUNITA NIKUMBH |
| Designation |
Professor HOD Department of Psychiatry |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar
2 floor main building Opposite S T Workshop
Palghar Boisar Road
Palghar None Thane MAHARASHTRA 400605 India |
| Phone |
917721076363 |
| Fax |
|
| Email |
sunita.nikumbh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Professor HOD |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar |
| Address |
Smt Malini Kishor Sanghavi Homoepathic medical College Opp Sumeru Navkar tirth Amod Karjan Road Vadodara Gujrat
Vadodara GUJARAT 391240 India |
| Phone |
9376939627 |
| Fax |
|
| Email |
chirashana@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunita Nikumbh |
| Designation |
Professor HOD Department of Psychiatry |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar
HoD office 2nd Floor College building Opposite S T Workshop
Palghar Boisar Road
Palghar None Thane MAHARASHTRA 401404 India |
| Phone |
7721076363 |
| Fax |
|
| Email |
sunita.nikumbh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeoapthic Institute Opp S T Workshop Palghar Boisar road Palghar 401404 |
|
|
Primary Sponsor
|
| Name |
DR SUNITA B NIKUMBH |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar
2Nnd floor Depart of Psychiatry Dr M L Dhawale Memorial Homoeopathic Institute Opposite S T Workshop
Palghar Boisar Road
Palghar 401404 |
| 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 |
Dr M L Dhawale Memorial Trust Hospital |
Dept of Psychiatry
Second Floor
Dr M L Dhawale Memorial Trust Hospital
Opp S T Workshop
Palghar Boisar Road
Palghar 401404 Thane MAHARASHTRA |
7721076363
sunita.nikumbh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Malini Kishor Sanghavi HMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicines i.e. constitutional medicines will be used for the care givers |
In Homoeopathy multiple medicines are used for the treatment purpose. Few names are as follows- Arsenic Album, Kali Carb, Lycopodium ,Natrum Mur etc |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) All the ages
b) Both genders
c) Care givers coming to dialysis center with CKD patients for minimum period of 9 months to 12 month period having stresses will be taken up for the study
|
|
| ExclusionCriteria |
| Details |
a) Care givers accompanying for less than 6 months
b) Professional Care givers giving care to CKD patients
c) Care givers having physical disability , diagnosed psychiatric illness or on psychiatric medication
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Understanding the various stressess of care givers of CKD patients
Learning how those stressess affect mind and body of care givers
Learning the various adaptive mechamism used by care givers while dealing the CKD patients
Exploring the role of Homoeopathic management of stressess and adaptive mechanism of care givers of CKD patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exploring the role of Homeopathic management of stresses and adaptive mechanism of care givers of CKD patients |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
28/07/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic kidney disease (CKD) is leading causes of death according to the Global Burden of Disease and has become a disease of public health importance. Patients with advanced stage of CKD often require assistance from other people i.e. care-givers; for their activities of daily living. Caregivers are people who are majorly involved in caring and assisting patients during the period of disease. It is associated with a huge socio-economic, physical and psychological burden on its sufferers and their caregivers. They often experience all sorts of mental health related issues and have an increased risk of stress, depression, anxiety and poor quality of life in the process of providing care and support to the primary patient i.e. for their close and loved ones. care-givers often neglects their psychological or mental health related issues. This neglect may subsequently impact negatively on the overall outcome of the CKD patients as well. Support interventions are likely to improve caregivers’ quality of life, satisfaction and ability to cope, which can indirectly improve medical and psychosocial outcomes for the care recipient. Developing effective strategies to deal with the expanding population of patients with chronic kidney disease (CKD) is challenging the resources of the nephrology community. In the field of Homoeopathy, no such study is conducted, hence the purpose and importance of the topic is first to identify the various mental health related issue in the care –givers and study the role of Homoeopathic interventions for them.
This study will give us idea that in a process of caring the patient how caregivers stand for themselves by using various adaptive or coping mechanisms. Which are the Homoeopathic remedies have those in qualitative way and why some fails to have those to land into mental health issues. And what changes are seen on quality of life of care givers and as well dialysis patient. This type of study should promote the use of Homoeopathic intervention in care givers of many chronic diseases everywhere in India and Western countries to reduce mental health issues caregiver to improve the quality of life of whole family. |