| 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
|
|
|
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
|
|
|
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
|
|
|
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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