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CTRI Number  CTRI/2022/05/042728 [Registered on: 23/05/2022] Trial Registered Prospectively
Last Modified On: 20/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the efficacy of Agnimantha Beej Choorna (Agnimantha powder) with Takra Anupana in Mutrashmari Pidam (Pain management in urolithiasis) 
Scientific Title of Study   Randomised control clinical study of efficacy of Agnimanth Beej Choorna with Takra Anupan in management of Mutrashmari Pidam w.s.r. to Urolithiasis pain  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Machhindra Bhagvan Gorad 
Designation  PG Scholar Shalyatantra 
Affiliation  Hon. Shri. Annasaheb Dange Ayurvedic Medical College ,Ashta, tal.Walva,Dist.Sangli pin code-416301 
Address  Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Department of Shalyatantra OPD NO.2
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Department of Shalyatantra OPD NO.2
Sangli
MAHARASHTRA
416301
India 
Phone  9767399711  
Fax    
Email  drmbgorad1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Vilas Patil 
Designation  Professor 
Affiliation  Hon. Shri. Annasaheb Dange Ayurvedic Medical College pin code 416301 
Address  Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Department of Shalyatantra OPD NO 2 OPD NO - 2 Opd no 2.
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Department of Shalyatantra OPD NO.2 OPD NO 2 Opd no 2.
Sangli
MAHARASHTRA
416301
India 
Phone  9422613195  
Fax    
Email  dr.patilmanoj77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj Vilas Patil 
Designation  Professor  
Affiliation  Hon. Shri. Annasaheb Dange Ayurvedic Medical College astha pin code 4163301 
Address  Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Shalyatantra Department OPD NO.2
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli Shalyatantra Department OPD NO.2
Sangli
MAHARASHTRA
416301
India 
Phone  9422613195  
Fax    
Email  dr.patilmanoj77@gmail.com  
 
Source of Monetary or Material Support  
Annasaheb dange Ayurved medical college ashta  
 
Primary Sponsor  
Name  Hon Annasaheb Dange Ayurvedic Medical College and post graduation research center Ashta 
Address  Vidyanagar,Ashta,Tal. Walva,Dist. Sangli 
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 Manoj patil  Dhanvantari Ayurved hospital Astha, tal Walwa Dist Sangli pin code 416301  Department of Shalyatantra OPD NO.2
Sangli
MAHARASHTRA 
9422613195

dr.patilmanoj77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   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. Ayurveda Condition: Mutrashmari, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: Mutrashmari Pidam ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mefenamic acid , Reference: K. D. Tripathi Pharmacology Book, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Agnimantha Beeja Churna , Reference: Vangsen samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient aged between 15 to 60 years will be selected irrespective of sex,prakruti,occupation,race,chronicity,socioeconomic status. 
 
ExclusionCriteria 
Details  1)K/C/O Malignancy of urinary tract
2)STD,HIV Infection
3)Uncontrolled DM
4)Pyelonephritis 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agnimantha Beeja Churna with Takra is effective in Mutrashmari Pidam ( Pain management). Pain will be assessed by VAS scale.   1 week.
Primary out come will be 1 week for both groups.  
 
Secondary Outcome  
Outcome  TimePoints 
Mefenamic acid is effective in Mutrashmari Pidam ( Pain management). Pain will be assessed by VAS scale.   2 week 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   30/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/05/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study will evaluate the efficacy of Agnimanth Beej Choorna in Mutrashmari Pidam.
During this trial trying to evaluate the untoward effect of Agnimanth Beej Choorna in Mutrashmari as their is no previous work done on Agnimanth beej Choorna so emphasis will be made to find out easy cost effective method to control Mutrashmari Pidam with no side effects.
 
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