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CTRI Number  CTRI/2025/03/082058 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 08/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Varunadigan Kashaya in BPH 
Scientific Title of Study   A Camparative Clinical Study Of Kanchnar Guggul And Varunadigan Kashaya In The Management Of Vatastheela WSR To BPH (Benign Prostate Hyperplasia) 
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 Prafull Kumar Rekwal 
Designation  PG Scholar 
Affiliation  Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 
Address  OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044

Bhopal
MADHYA PRADESH
462044
India 
Phone  8085859836  
Fax    
Email  rekwalprafull@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay M Kapadnis 
Designation  Professor In Shalya Tantra Department 
Affiliation  Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 
Address  OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044

Bhopal
MADHYA PRADESH
462044
India 
Phone  9479772912  
Fax    
Email  drajay2912@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prafull Kumar Rekwal 
Designation  PG Scholar 
Affiliation  Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 
Address  OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044

Bhopal
MADHYA PRADESH
462044
India 
Phone  8085859836  
Fax    
Email  rekwalprafull@gmail.com  
 
Source of Monetary or Material Support  
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 
 
Primary Sponsor  
Name  Dr Prafull Kumar Rekwal 
Address  PG Scholar Shalya Tantra Department,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 
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 
Dr Prafull Kumar Rekwal  Rani Dullaiya Smriti Ayurved Hospital Bhopal  OPD No.7 Department Of Shalya Tantra, Rani Dullaiya Smriti Ayurved College and Hospital Bhopal M.P.
Bhopal
MADHYA PRADESH 		 8085859836

rekwalprafull@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: varunadigan kashaya, Reference: sushrut sutrasthan 38/8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: varunadigan kashaya will be given
2Intervention ArmDrugClassical(1) Medicine Name: Kanchnar Guggul, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: Kanchnar Guggul will be given
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Male 
Details  The Patients Having Classical Symptoms Or Clinically Diagnosed with BPH Disease. 
 
ExclusionCriteria 
Details  Age below 50 years.
Patients with acute retention.
Known malignant condition of uro-genital system.
Patient associated with other systemic disorders like Renal Failure, Malignancy, Immunocompromised patients etc. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
assessed for the efficacy in the management of vatastheela  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced in symptoms of frequency urination, urgency of urination,nocturia and complete relief of hyperplasia.  30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/03/2025 
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="0"
Months="0"
Days="9" 
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   This is a double group , open label, comparative clinical study on the efficacy of kanchnar guggul and varunadigan kashaya in the management of vatastheela w.s.r. to BPH .The primary outcome is to reduce frequency, urgency and nocturia will be measured by subjective and objective parameters. 
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