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CTRI Number  CTRI/2024/02/063305 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
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 STONE  
Scientific Title of Study   A CLINICAL STUDY ON THE HOMOEOPATHIC MANAGEMENT OF RENAL CALCULI  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G KARTHIKEYANI 
Designation  POST GRADUATE SCHOLAR 
Affiliation  Vinayaka missions Homoeopathic Medical college and Hospital  
Address  DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Sankari Main Road NH 47 Chinnaseeragappadi Po Salem

Salem
TAMIL NADU
636308
India 
Phone  8838017893  
Fax    
Email  drkarthig11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A SARAVANAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Vinayaka missions Homoeopathic Medical college and Hospital  
Address  DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Sankari Main Road NH 47 Chinnaseeragapadi Po Salem

Salem
TAMIL NADU
636308
India 
Phone  9843437327  
Fax    
Email  asrbhms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A SARAVANAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Vinayaka missions Homoeopathic Medical college and Hospital  
Address  DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Sankari main road NH 47 Chinnaseeragappadi Po Salem

Salem
TAMIL NADU
636308
India 
Phone  9843437327  
Fax    
Email  asrbhms@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, chinnaseeragapadi P O Salem TAMIL NADU 636308 
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital  
Address  Sankari main road NH 47 Chinnaseeragappadi Po Salem 
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 G Karthikeyani  Vinayaka Missions Homoeopathic Medical College and Hospital  Room No : 3 B - PG Department of Homoeopathic Materia Medica OPD Medical unit II, Ground floor, Hospital block, VMHMCH, NH47, Sankari main road, Chinnaseeragapadi P O Salem
Salem
TAMIL NADU 		 8838017893

drkarthig11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee VMKVMC&H  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicinal management (similimum)  Homoeopathic medicines are selected based on individualization of the patient. Based on the susceptibility of the patient the dose is selected. Medicine is administered via oral route. Follow up is taken once in every 15 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects of both sexes between 20-50 age groups.
Subjects with size of the calculi up to 10mm.
Subjects with position of calculi in kidney, ureter & urinary bladder.
Clinical signs & symptoms of renal calculi.
Ultrasonography of abdomen & pelvis.
Based on the Urolithiasis symptom score (USS). 
 
ExclusionCriteria 
Details  Subjects under any other systemic diseases like cardiovascular, endocrine diseases or on other treatment therapies.
Subjects with position of Calculi in lower pole of kidney.
Patient with kidney function impairment.
Calculous Pyelonephritis.
Renal Failure.
Congenital Anomaly of kidney. 
 
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 
Usg of Abdomen & Pelvis   At Baseline & After 6 months  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 31/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  

Kidney stone which is also called renal calculus. A kidney stone is a firm, crystalline mineral material formed within the kidney (or) urinary tract become so huge as to impair usual renal function. Kidney stones are frequent cause of blood in the urine (haematuria) and often severe pain in the region of abdomen, flank, or groin. This condition of kidney stones is termed as nephrolithiasis. Having stones at any location in the urinary tract is termed as urolithiasis, and the term ureterolithiasis is referring to stones situated in the ureters. Renal calculi are estimated that approximately 2% of the population experiences renal stone disease at some time in their life with male female ratio of 2:1. The peak incidence is observed in 2nd to 3rd decades of life.Homoeopathy has great scope in treating renal stones, it is cost effective, risk free and effective  and prevention aspects as per Hahnemann’s directions procedures, the homoeopathic medicines increase the kidney resistance and reduces the pain, prevent the surgical intervention, dissolves the stone, prevents recurrences and further complications. Homoeopathy plays an important role in the effective management of Renal calculi. 

 
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