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CTRI Number  CTRI/2025/02/080195 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Homoeopathy in Renal Stone 
Scientific Title of Study   PROSPECTIVE CLINICAL STUDY TO VERIFY THE EFFECT OF HYDRANGEA ARBORESCENS IN CASES OF RENAL CALCULI ASSESSED BY GUYS STONE SCORE 
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 Drashti Gadhiya 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College, Parul University 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot

Rajkot
GUJARAT
360002
India 
Phone    
Fax    
Email  drashti.gadhiya2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vani Oza 
Designation  HOD/Associate Professor 
Affiliation  Rajkot Homoeopathic Medical College, Parul University 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9428052673  
Fax    
Email  vanioza8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vani Oza 
Designation  HOD/Associate Professor 
Affiliation  Rajkot Homoeopathic Medical College, Parul University 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot


GUJARAT
360002
India 
Phone  9428052673  
Fax    
Email  vanioza8@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College 
Address  Department of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, Parul University, B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot 
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 Drashti Gadhiya  Sainath Homoeopathic Hospital  Department of Materia Medica, Rajkot Homoeopathic Medical College, B/h Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT 		 7984305767

drashti.gadhiya2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat  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, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Various Homoeopathic remedies in 30, 200 and 1m potency at every week follow up depending upon the demand of case for one week and study to be conducted for 9 months to 0ne year 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Pre- diagnosed and Diagnosed cases of renal calculi.

Patient who are voluntarily taking Homoeopathic Medicines and Patients who voluntarily participate in research. 
 
ExclusionCriteria 
Details  Age below18 and above 45years.
Patient having any other systemic disease example Diabetes Mellitus, Hypertension, Hyperparathyroidism etc.
Patient having any other renal pathology other than renal calculi like Acute kidney injury, Acute Renal failure, chronic Renal failure, Glomerulonephritis etc.
Patient having terminal disease like Cancer, HIV etc.
Individual utilizing Allopathic medicine/ any other pharmacological Treatment other than homeopathy are excluded.
Pregnant women and lactating women are excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the effectiveness of Hydrangea arborescens in cases of renal calculi. To study of Sign & Symptoms of Hydrangea arborescens related to renal calculi. To assess the clinical utility of GUY’S stones core.  this will be achieved within 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
For the effective assessment and evaluation, disease intensity scores will also be
maintained according to Guy’s Stone Score. 		 this will be achieved within 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/02/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashti.gadhiya2000@gmail.com].

  6. For how long will this data be available start date provided 06-01-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   THE MATERIAL UTILIZED FOR THE STUDY o Informed consent i.e., to be signed by every patient. o A specialized designed Case – taking Performa. (Note – all the records, forms and reports of the patient will be kept confidential.) o Suitable Materia Medica books, journals, articles, medicine and surgery books, information from authentic online sites. o The medication will be provided by the dispensary of Sainath Homoeopathic Hospital and obtained from an authentic homoeopathic pharmacy.

METHOD OF COLLECTION OF DATA The study shall be performed in following ways: o Type of study: Qualitative, Interventional / Clinical,Prospective study o Sample size:40cases o Duration:9 months o Sample Method: Random sampling 

INTERVENTION GUIDELINES: o Individualized Homoeopathic Medicine selection is based on the Totality of Symptoms for each caseas their similimum and Hydrangea arborescence is given to suitable patient. o Potency, dose, and repetition are determined by the patient’s susceptibility. 

CASE-TAKING PROCEDURE o Guidelines for case taking, as outlined by Dr. Hahnemann in aphorisms §83- §104(15), are adhered to when using the Case Performa at Sainath Homoeopathic Hospital. 

SELECTION OF MEDICINE o Hydrangea arborescence medicine will be given to suitable patients. 

SELECTION OF POTENCY o According to pathology and guideline related to selection of potency given under organon of medicine and as per requirement of patient. 

DOSE & REPETITION o The administration of the remedy will adhere to the principles outlined in the Homoeopathic Organon of Medicine (15) and as per patient requirement. 

ROUTE OF ADMINISTRATION OF MEDICINE o All medications will be administered orally. 

FOLLOW UP AND MONITORING o Follow–up of each case will be taken at 15 days or as per requirement for patient o USG performed at three-month intervals. 

RECORDS o All the records will be maintained as per standard procedure of institution

 
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