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CTRI Number  CTRI/2024/01/061098 [Registered on: 03/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   kidney stone treatment with kokilaksha Panchag kshar 
Scientific Title of Study   Randomized open controlled clinical trial to evaluate the efficacy of Kokilaksha panchang kshar in Mootrashmari with special reference to urolithiasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Vaibhav Sadashiv Magar 
Designation  Associate Professor 
Affiliation  Yashwant Ayurvedic college post graduation training and research centre kodoli 
Address  Yashwant Ayurvedic College PGT And Research centre kodoli Shalyatantra department OPD NO 4
Yashwant Ayurvedic College Post Graduation Traing And Research centre kodoli Shalyatantra department
Kolhapur
MAHARASHTRA
416114
India 
Phone  8600667796  
Fax  --  
Email  dr.vaibhav83magar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Srinivas 
Designation  Professor and HOD 
Affiliation  Yashwant Ayurvedic college post graduation training and research centre kodoli 
Address  Yashwant Ayurvedic College Post Graduation Training and Research Centre Kodoli Shalyatantra Department
Yashwant Ayurvedic College Post Graduation Training and Research Centre Kodoli Shalyatantra Department
Kolhapur
MAHARASHTRA
416114
India 
Phone  9503147698  
Fax  --  
Email  drsrinivast@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhav Sadashiv Magar 
Designation  Associate Professor 
Affiliation  Yashwant Ayurvedic college post graduation training and research centre kodoli 
Address  Yashwant Ayurvedic College PGT And RC Kodoli Shalyatantra Department OPD NO 4
Yashwant Ayurvedic College PGT And RC Kodoli Shalyatantra Department OPD NO 4
Kolhapur
MAHARASHTRA
416114
India 
Phone  8600667796  
Fax  --  
Email  dr.vaibhav83magar@gmail.com  
 
Source of Monetary or Material Support  
Natural from Kokilaksha herb. 
 
Primary Sponsor  
Name  Dr Vaibhav Sadashiv Magar 
Address  Yashwant Ayurvedic college PGT and RC Kodoli dist kolhapur 
Type of Sponsor  Other [self] 
 
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 
DrVaibhav sadashiv magar  Yashwant Ayurvedic college post graduation and Research centre  A/P Kodoli Tahsil Panhala Kolhapur Shalyatantra OPD no 4
Kolhapur
MAHARASHTRA 
8600667796

dr.vaibhav83magar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical commitee  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. Ayurveda Condition: Urinary Calculus,Unspecified, (2) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: MUTRAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Calculus present in kidney,Bladder,Ureter single,bilateral
2)USG showing calculus of size equal to or less than 8mm in size
3)Subject showing sign and symptoms of mootrashmari.
4)Recurrent and non recurrent history of stone. 
 
ExclusionCriteria 
Details  1)Calculus size more than 8mm
2)Subject require immediate surgical management.
3)Patient having renal failure/impairement
4)Gross Haematuria./Impacted stone
5)Shukrashmari
6)Patient having any systemic diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease in stone size in mm according to USG.  After 28 days. Decrease in stone size in mm will be recorded according to USG. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms like pain,burnig micturation,dysuria,haematuria  28 days 
 
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 2/ Phase 3 
Date of First Enrollment (India)   11/01/2024 
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response - None of the above

  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 (Others) - 

  6. For how long will this data be available start date provided 15-10-2023 and end date provided 15-05-2025?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   This study is Randomized open controlled clinical study to evaluate the efficacy of Kokilaksha panchang kshar in Mootrashmari w.s.r to Urolithiasis.Study will be carried out in shalyatantra department of Yashwant ayurvedic college and Hospital kodoli,kolhapur.The observation would be drawn on the basis of symptoms after treatment given. 
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