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CTRI Number  CTRI/2026/01/101632 [Registered on: 20/01/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Use of physical, psychological and social factors in forming totality for homoeopathic management of patients with end stage renal disease on maintenance hemodialysis: A prospective case series 
Scientific Title of Study   Application of the bio-psycho-social(BPS) model in totality formulation for homeopathic management of end stage renal disease patients on maintenance hemodialysis: A prospective case series 
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 Sanskruti Pravin Paunikar  
Designation  Post Graduate Student  
Affiliation  Dr M L Dhawale Memorial Homeopathic Insitute, Palghar 
Address  307, Department of practice of medicine, Dr M L Dhawale Memorial Homeopathic institute, Palghar-boisar road, opposite S T Workshop, Palghar-401 404, India. Thane Maharashtra 401404 India

Palghar
MAHARASHTRA
401404
India 
Phone  7776004980  
Fax    
Email  Sanskrutipaunikar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Namrata Pandey 
Designation  Assistant professor 
Affiliation  Dr M L Dhawale Memorial Homeopathic Insitute, Palghar 
Address  07, Department of practice of medicine, Dr M L Dhawale Memorial Homeopathic institute, Palghar-boisar road, opposite S T Workshop, Palghar-401 404, India. Thane Maharashtra 401404 India

Palghar
MAHARASHTRA
401404
India 
Phone  9220286246  
Fax    
Email  namratapanday2810@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namrata Pandey 
Designation  Assistant professor 
Affiliation  Dr M L Dhawale Memorial Homeopathic Insitute, Palghar 
Address  07, Department of practice of medicine, Dr M L Dhawale Memorial Homeopathic institute, Palghar-boisar road, opposite S T Workshop, Palghar-401 404, India. Thane Maharashtra 401404 India

Palghar
MAHARASHTRA
401404
India 
Phone  9220286246  
Fax    
Email  namratapanday2810@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr M L Dhawale Memorial Homeopathic Insitute palghar 
Address  Dr M L Dhawale Memorial Homeopathic Institute Palghar, Palghar-Boisar Road, Opp S T Workshop, Dist. Palghar Maharashtra, India, Thane, Maharashtra, 401404 
Type of Sponsor  Research institution and hospital 
 
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 Sanskruti Paunikar  Dr M L Dhawale memorial homeopathic insitute   Dr M L Dhawale Memorial Homeopathic Institute Palghar, Palghar-Boisar Road, Opp S T Workshop, Dist. Palghar Maharashtra, India, Thane,
Palghar
MAHARASHTRA 
7776004980

Sanskrutipaunikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee, MLDMHI, Palghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualizeed Homeopatic Medicine  Totality will be formed after considering the bio-psych-social model  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed with end stage renal disease on maintaince hemodialysis
Age group between 18-65 years
Patients with both sexes
The cases must have appropriate data recording of chief complaints with proper LSMC, proper ODP, life space 
 
ExclusionCriteria 
Details  Patients taken any other mode of therapy along with homeopathic treatment and standard line of treatment
Patients who progressed into complications and would require other mode of dialysis like CRRT or CAPD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and apply the biopsychosocial model in the formulation of totality in patients with end-stage renal disease on maintenance haemodialysis.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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/ Phase 3 
Date of First Enrollment (India)   05/02/2026 
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  

The End Stage Renal Disease is the final stage of chronic kidney disease (CKD), in which the kidney has lost it’s all ability to function effectively. Due to severe loss of kidney functions individual with ESRD requires dialysis however, Chronic Renal failure is a process, and understanding this process is of utmost importance from a homoeopathic angle, as ESRD is multi-factorial, multi-miasmatic illness which is increasing rapidly across the globe in the light of increasing various lifestyle disorders. Recent articles and even various stake holders are recognizing that it is very important to look into overall holistic aspect of illness because it influences disease outcomes, the individual himself is ill and not only his Renal health and  considerable care should be given so that maintenance of artificial prolongation of life is as smooth as it can be but no definite guidelines are available to achieve this in practical application  BPS model is a holistic framework for understanding and treating disease states. The BPS model helps in the formulation of totality based on the symptoms for the selection of remedy through detailed case taking leading to identification of predisposition, mental disposition, precipitating factors, aggravating factors, maintaining factors, characteristic mental and physical expressions & environmental factors Thus, this study understands ESRD patients on MHD through the BPS Model, and its application in practice would enrich further knowledge base regarding antecedents of ESRD and amount to a large number of successful prescriptions based on holistic homoeopathic principles


 
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