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CTRI Number  CTRI/2024/04/066098 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study to access the homoeopathic management of urolithiasis from individualized medicinal approach vs organopathic hydrangea arborescens approach 
Scientific Title of Study   A Randomized comparative interventional study to assess the efficacy of individualized homoeopathic medicine vis a vis hydrangea arborescens in management of cases of urolithiasis  
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 Kumkum Sharma  
Designation  PG Scholar 
Affiliation  Dr m p k Homoeopathic Medical College Hospital And Research Centre  
Address  Department Of Practice Of Medicine Dr m p k Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029

Jaipur
RAJASTHAN
302029
India 
Phone  8005945367  
Fax    
Email  kumkumsharma2021ks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Virendra Chauhan  
Designation  Associate Professor 
Affiliation  Dr m p k Homoeopathic Medical College Hospital And Research Centre  
Address  Department Of Practice Of Medicine Dr m p k Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029

Jaipur
RAJASTHAN
302029
India 
Phone  9983548853  
Fax    
Email  PMpg2724dept@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kumkum Sharma  
Designation  PG Scholar 
Affiliation  Dr m p k Homoeopathic Medical College Hospital And Research Centre  
Address  Department Of Practice Of Medicine Dr m p k Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029

Jaipur
RAJASTHAN
302029
India 
Phone  8005945367  
Fax    
Email  kumkumsharma2021ks@gmail.com  
 
Source of Monetary or Material Support  
Dr Girendra Pal Homoeopathic Hospital And Research Centre collegiate hospital Dr m p k homoeopathic medical college hospital and research centre A constituent college of homoeopathy university saipura sanganer jaipur rajasthan 302029 
 
Primary Sponsor  
Name  Dr m p k Homoeopathic Medical College Hospital And Research Centre  
Address  Plot No 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 
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 Kumkum Sharma  Dr Girendra Pal Homoeopathic Hospital and Research Centre  Department of Practice of Medicine OPD room no 1 Dr m p k Homoeopathic Medical College Hospital And Research Centre Homoeopathy University Plot no 10 11 12 Ward no 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN 		 8005945367

kumkumsharma2021ks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HOMOEOPATHY UNIVERSITY JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydrangea arborescens  Medicine shall be given in any potency as per the requirement of the case Medicines will be obtained from a GMP certified company Oral route of administration Dispensing from certified pharmacist in college dispensary Hahnemannian guidelines of organon of medicine in the form of globules number 40 Dose and repetition as per the needs of case  
Comparator Agent  Indivualized Medicines  Homoeopathic medicines selected on the basis of individualized approach after analysis evaluation and constructing totality of symptoms with repertorization Medicine shall be given in any potency as per the requirement of the case Medicines will be obtained from a GMP certified company Oral route of administration Dispensing from certified pharmacist in college dispensary Hahnemannian guidelines of organon of medicine in the form of globules number 40 Dose and repetition as per the needs of case  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Cases both asymptomatic and symptomatic with radiological evidence of urolithiasis
Cases giving consent for study
Diagnosed cases who have taken medicines from any other system of treatment will also be consider after a wash out period of 15 days
All socioeconomic status 
 
ExclusionCriteria 
Details  Patient not willing to give consent
Patient with major systemic disorder and autoimmune diseases
Cases with hydronephrosis uti uremia acute retention of urine for more than 24 hours
Cases of staghorn calculi.
Gross developmental or structural anomalies
Pregnant women and lactating mothers are not included 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment as per pre and post uss score chart and radiological evidence usg or xray pre and post treatment
From this study we expect that hydrangea arborescens or individualized homoeopathic medicines will give beneficial results in the management of cases of urolithiasis
Helpful in enriching existing materia materia and improve the knowledge of clinicians and further encourage future researcher 		 Follow up at regular interval of 15 or early if required or as per the requirement of the case
Final assessment at 9 months or 3 months prior to the conclusion of study 
 
Secondary Outcome  
Outcome  TimePoints 
At the end it will widen the approach to manage the cases of urolithiasis and we may expect better management from homoeopathic medicines   12 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Aim: To compare the efficacy of homoeopathic medicines in management of urolithiasis between patients receiving homoeopathic medicines selected on the basis of individualized approach vis a vis predefined hydrangea arborescens
Objectives:1 To assess the efficacy of homoeopathic medicines selected on the basis of individualized approach in the management of urolithiasis
2. To assess the efficacy of Homoeopathic Medicines selected as a predefined hydrangea arborescens 
3.To compare the efficacy of Individualized approach vs predefined hydrangea arborescens.
4. To compare the extent of improvement of symptoms in patients of urolithiasis using Urolithiasis Symptom Score.
5. To compare the extent of improvement in patients of urolithiasis via investigation / imaging verification.
 
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