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CTRI Number  CTRI/2024/10/075329 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to compare the efficacy of khadireebeej powder with gokshura powder in the management of kidney stone. 
Scientific Title of Study   Randomised controlled clinical trial to compare the efficacy of khadireebeej churna with gokshura churna in the management of mootrashmari. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivam Sunil Upadhyay 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  8286398896  
Fax    
Email  Shivamupadhyay875@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNandkishor VBORSE  
Designation  Professor & HOD Shalyatantra Department 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  9422032696  
Fax    
Email  drnvborse@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivam Sunil Upadhyay 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  8286398896  
Fax    
Email  Shivamupadhyay875@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India 
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune 411011  
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 Shivam Sunil Upadhyay  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA 		 08286398896

Shivamupadhyay875@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe, TAMV pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadireebeej Churna, Reference: Bhaishyajaratnavali 35/8 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: jal-), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Gokshur Churna, Reference: Sushrut chikitsa 7/20, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: jal), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Size of calculus- A known diagnosed case of renal calculus having calculus 6 to 8mm. 
 
ExclusionCriteria 
Details  Patient who are suffering from severe systemic disorders like renal failure,Carcinoma
Known case of DM, HTN, Asthma, HIV, HbsAg.
Congenital anomalies of kidney.
The pregnant women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
decrease in hematuria, abdominal pain, burning micturition and site of pain  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
decrease in hematuria, abdominal pain, burning micturition and site of pain  28 days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   22/10/2024 
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   The study will be intervened by the treatment of Khadireebeej Churna and Gokshura Churna to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. 
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