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CTRI Number  CTRI/2022/03/041470 [Registered on: 30/03/2022] Trial Registered Prospectively
Last Modified On: 28/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathic Medicine In The Management Of Kidney Stones 
Scientific Title of Study   Efficacy Of Homoeopathic Medicine In The Management Of Nephrolithiasis Using Homoeopathic Medical Repertory By Robin Murphy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suganya K M 
Designation  Post Graduate Scholar 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Department of Repertory OPD Room No 2C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India

Salem
TAMIL NADU
636308
India 
Phone  8610846809  
Fax    
Email  drsuganyamahalingam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr J Senthil Kumar 
Designation  Professor and Head of Department 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Department of Repertory OPD Room No 2C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India

Salem
TAMIL NADU
636308
India 
Phone  9842780556  
Fax    
Email  drjsenthil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr J Senthil Kumar 
Designation  Professor and Head of Department 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Department of Repertory OPD Room No 2C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India


TAMIL NADU
636308
India 
Phone  9842780556  
Fax    
Email  drjsenthil@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India 
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital  
Address  NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India 
Type of Sponsor  Private medical college 
 
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 J Senthil Kumar  Vinayaka Missions Homoeopathic Medical College and Hospital   Room No 2 C - PG Dept of Repertory OPD Unit Ground Floor Hospital Block Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India
Salem
TAMIL NADU 
9842780556

drjsenthil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES  Homoeopathic medicines are selected based on individualization. The dose is selected based on the susceptibility of the patient. Medicine is administered via oral route. Follow up is taken in every 15 days. Maximum treatment period per patient under study is 6 months 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects of all age groups, both sexes different socioeconomic status. Diagnostic criteria will be based on clinical presentation and USG of Abdomen.
Calculi present in both the kidney is only included. 
 
ExclusionCriteria 
Details  Cases with calculi measuring more than 7mm.
Acute renal pain.
Calculous Pyelonephritis.
Systemic illness.
Poorly functioning kidney
Renal failure
Metabolic disorder
Congenital anomaly
Calculi present in ureter and bladder
Subjects with systemic affections of irreversible pathological changes in the body 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
BASED ON THE ULTRASONOGRAPHY OF ABDOMEN,
CLINICAL SIGNS AND SYMPTOMS OF RENAL CALCULI ARE ASSESED 
AT BASELINE AND AFTER 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
IT IS EXPECTED THAT THE PROPOSED
STUDY WILL BE USEFUL IN REDUCING THE
SYMPTOMS OF RENAL CALCULI 
AT BASELINE AND AFTER 6 MONTHS 
 
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   Phase 4 
Date of First Enrollment (India)   11/04/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Nephrolithiasis is one of the most common disease of urinary tract. It is becoming one of the emerging challenges in the medical field because of modern lifestyle changes, sedentary habits, unhealthy dietary plan and overweight problems. The prevalence is increasing throughout the industrialized world. It is common affecting individuals of all countries and ethnic groups. It is more common in male as compared to female. More common in whites than in black. It shows a familial predisposition.
Homoeopathy is a mode of treatment which is based on individualization and its holistic approach treats effectively without adverse effect. It is more beneficial to manage nephrolithiasis of with low cost by Homoeopathic medicine as compared to other system of medicine. Robin Murphy repertory is a unique repertory, which helps a practitioner to find out the similimum on the basis of clinical as well as classical symptoms. Murphy’s concept of totality is based on clinical as well as classical homoeopathic practice. Robin Murphy repertory is more effective and most authenticated repertory in treatment of nephrolithiasis since clinical and diagnostic symptoms are available. So in my dissertation of Nephrolithiasis I have chosen Robin Murphy repertory.
 
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