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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  
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 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  
Status 
Not Applicable 
 
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.

 
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