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CTRI Number  CTRI/2024/05/067145 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment of Hydronephrosis 
Scientific Title of Study   CLINICAL UTILITY OF BOERICKE’S MATERIA MEDICA IN CASE OF HYDRONEPHROSIS. 
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 Dinesh Chand 
Designation  Postgraduate trainee  
Affiliation  State National Homoeopathic Medical College and Hospital,Lucknow. 
Address  Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  7452804634  
Fax    
Email  drdineshchand627@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nutan Sharma 
Designation  Reader 
Affiliation  State National Homoeopathic Medical College and Hospital,Lucknow 
Address  Department of Practice of Medicine , State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  8178562292  
Fax    
Email  drnutansharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dinesh Chand 
Designation  Postgraduate trainee  
Affiliation  State National Homoeopathic Medical College and Hospital,Lucknow 
Address  Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  7452804634  
Fax    
Email  drdineshchand627@gmail.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College and Hospital,Lucknow 
 
Primary Sponsor  
Name  Dr Dinesh Chand 
Address  Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010 
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 Dinesh Chand  State National Homoeopathic Medical College and Hospital,Lucknow.  Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow
UTTAR PRADESH 
7452804634

drdineshchand627@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N133||Other and unspecified hydronephrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic medicine  Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Benign prostatic hyperplasia after detailed case taking and with the help of Boericke’s materia medica. Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the cases. The duration of the study will be for 6 months. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient of age between 25 years to 70 years and of both sexes.
2. Patient suffering from Hydronephrosis who are willing to give consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Patient of age below 25 years.
2. Patient suffering from congenital anomaly.
3. Any other condition requiring emergency or surgical intervention.
4. Patient unwilling for inclusion in the study and those who are not able to come for follow-up. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare and analyse the difference in the Hydronephrosis Severity Score before and after 6 months of treatment to know the utility of individualized homoeopathic medicine.  12 weeks, 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in the quality of life of the patient at baseline and after 6 months of treatment by comparing the changes in the Hydronephrosis Severity Score.  12 weeks, 24 weeks  
 
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)   20/05/2024 
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  

This is a prospective, single arm, open label, interventional clinical study. Hydroureter and hydronephrosis are common entities encountered in primary care medicine, emergency medicine as well as nephrology and urology practices. Hydronephrosis is defined as dilatation and distension of the renal collecting system of one or both kidneys due to obstruction of urine outflow distal to the renal pelvis (i.e., ureter, urinary bladder, and urethra). Hydronephrosis remains the most challenging renal disorder with a high burden of disease. Symptomatic early-stage hydronephrosis urgently needs to be identified and defined, as efficient early-stage case finding and diagnosis in primary care would enable health-care providers to proactively and substantially reduce the burden of disease through proper management including structured education, prevention of other renal disease like renal cyst, addressing lifestyle-related risk factors for disease progression. The aim of this study is to assess the clinical utility of individualized homoeopathic medicine in the management of cases of hydronephrosis by using Boericke’s materia medica. A total number of 30 patients suffering from hydronephrosis & fulfilling the eligibility criteria will be selected from OPD of SNHMC.Data will be collected on the basis of detailed case-taking from patient , physician’s observation and calculation of Hydronephrosis severity score. Outcome will be assessed at baseline and every month up to 6months.Data obtained after the management of 6 months will be analyzed to draw the inference using appropriate statistical tools.

 
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