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CTRI Number  CTRI/2025/09/095055 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Other (Specify) [Matra Basti and Oral Drug]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Benign Prostatic Hyperplasia using Varunadya Taila Matra Basti and Trikatu Gutika. 
Scientific Title of Study   Comparative Evaluation of Varunadya Taila Matra Basti and Trikatu Gutika in Vatashtheela (Benign Prostatic Hyperplasia). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar Gupta 
Designation  Professor 
Affiliation  Rishikul Campus, Haridwar. 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  9412856414  
Fax    
Email  akg1409@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar Gupta 
Designation  Professor 
Affiliation  Rishikul Campus, Haridwar. 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  9412856414  
Fax    
Email  akg1409@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sakshi Bisht 
Designation  PG Scholar 
Affiliation  Rishikul Campus, Haridwar. 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7253995868  
Fax    
Email  sakshibisht28@gmail.com  
 
Source of Monetary or Material Support  
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand, India 249401 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Railway Road, Harrawala, Dehradun Uttarakhand India, 248001 
Type of Sponsor  Government 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 
Sakshi Bisht  Rishikul Campus, Haridwar.  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Uttarakhand Ayurved University, Haridwar. 249401
Hardwar
UTTARANCHAL 		 7253995868

sakshibisht28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayuved University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, (2) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak Samhita, Procedure details: 30 ml of Varunadya Taila will be administered through rectal route, to a group of 18 patients, for 21 days, just after meal.)
(1) Medicine Name: Varunadya Taila, Reference: Bhaishajya Ratnawali, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days
2Intervention ArmDrugClassical(1) Medicine Name: Trikatu Gutika, Reference: Bhavaprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - In a group of 18 patients, 2 tablets of Trikatu Gutika, twice a day, will be given orally, for 21 days.
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Age-50 or above 50 years.
Sex - Male
Patients with classical signs & symptoms of Vatashtheela. 
 
ExclusionCriteria 
Details  Age below 50 years.
Patient with acute retention.
Known Malignant condition of Uro-genital system.
Patient associated with other systemic disorders- Renal Failure, immune-compromised patients, etc.
Patient not willing to undergo trial.
 
 
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 
Relief in the symptoms like frequency of urination in day and night time, urgency of
urination & relief in signs such as enlargement of Prostate. 		 Zero, 7th, 14th, 21st day and after treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Expected improvement in the quality of life of
patients by relief in the symptoms like decrease
in the frequency of Micturition by patient during day & night, Urgency, as well as expected relief in
reduction of size of Prostate gland. 		 Zero 7th 14th 21st day & after treatment
 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   28/09/2025 
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="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   BPH is a non- cancerous disease and it is a part of normal ageing process. The most widely acknowledged cause is an imbalance between androgen and estrogen. It cause symptoms like increased frequency of micturition, nocturia, urgency, hesitancy etc. and signs like enlargement in Prostate size. This study is an interventional, open level, double group trial, "Comparative Evaluation of Varunadya Taila Matra Basti and Trikatu Gutika in Vatashtheela (Benign Prostatic Hyperplasia). The case will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervened under two groups of 18 patients each, with one group receiving Varunadya Taila (Matra Basti) and the other group Trikatu Gutika (orally), duration of trial will be 21 days. Assessment criteria will be done on subjective and objective parameters. Subjective parameters on the basis of International Prostate Symptom Score (IPSS) and objective parameters on residual urine volume and prostate size volume.  
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