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CTRI Number  CTRI/2024/05/066969 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparitive Study To Know The Efficacy Of Mahanarayana Taila And Punarnavadi Kashaya In The Treatment Of Vatashteela (BPH) 
Scientific Title of Study   A Randomized Clinical Trial To Evaluate The Efficacy Of Mahanarayana Taila Uttar Basti And Punarnavadi Kashaya Yoga Basti In The Management Of Vatastheela With Special Reference To Benign Prostatic 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 Kashyap Patel 
Designation  Post Graduate Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Room No 403, department of Shalya Tantra, Parul Institute Of Ayurved, Parul University, Limda, Waghodiya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9409563313  
Fax    
Email  patelkashyapguj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aswin Haridas 
Designation  Associate Professor, Department Of Shalya Tantra,  
Affiliation  Parul Institute Of Ayurved 
Address  Room No 403, department of Shalya Tantra, Parul Institute Of Ayurved, Parul University, Limda, Waghodiya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9446023359  
Fax    
Email  Draswinharidas89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aswin Haridas 
Designation  Associate Professor, Department Of Shalya Tantra,  
Affiliation  Parul Institute Of Ayurved 
Address  Room No 403, department of Shalya Tantra, Parul Institute Of Ayurved, Parul University, Limda, Waghodiya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9446023359  
Fax    
Email  Draswinharidas89@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul Institute Of Ayurved, Parul University, PO Limda, Tal Waghodiya, Vadodara, 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Room no 403 , department of Shalya Tantra, Parul Institute of Ayurved, Parul University 
Type of Sponsor  Research institution and hospital 
 
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 Kashyap Patel  Parul Ayurved Hospital  OPD No 106 Shalya Tantra OPD, Parul Ayurved Hospital, , Parul University, Limda, Waghodiya, Vadodara 391760
Vadodara
GUJARAT 		 9409563313

patelkashyapguj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PARUL INSTITUTE OF AYURVED PARUL UNIVERSITY  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
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Sushruta Samhita, Procedure details: Procedure will be done incorporated with yoga basti )
(1) Medicine Name: Mahanarayana Taila, Reference: Bhaishajya Ratnavali, Route: Urethral, Dosage Form: Taila, Dose: 48(ml), Frequency: od, Duration: 3 Days
2Intervention ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Ashtanga Hridaya, Procedure details: Niruha Anuvasana and Uttar basti for 8 days)
(1) Medicine Name: Punarnavadi kashaya and Ashmarihara Kashaya, Reference: Sharangadhara Samhita, Siddhayoga Sangraha, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Varunadi Ghrita and Dashmoola Taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days
3Comparator ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Ashtanga Hridaya, Procedure details: Niruha and Anuvasana for 8 days)
(1) Medicine Name: Punarnavadi Kashaya and Ashmarihara Kashaya, Reference: Sharangadhara Samhita, Siddhayoga Sangraha, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Varunadi Ghrita and Dashmoola Taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Patients having the sign and symptoms of Vatastheela (BPH)
Incomplete evacuation of urine
Increased Frequency Of Micturition
Intermittency
Straining
Nocturia 
 
ExclusionCriteria 
Details  CA of prostate
Bladder neck stenosis
Neuropathic disorders of bladder
Prostate more than 60 gm and excessive post voidal urine
Active UTI
Haematuria secondary to renal & bladder stone, cystic kidney disease,
Sickle cell anaemia
Anaemic patient with Hb below 6 gm%
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce symptoms of Incomplete evacuation of urine, Increased Frequency Of Micturition, Intermittency, Straining, Nocturia.
 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Patient health improve.   28 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 01/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 INTRODUCTION  BPH (Benign Prostatic Hyperplasia) is having the 2nd highest incident in geriatrics practice.  The Prostate gets enlarged when a men cross age of 40 years.  One in four men above 40 years and one in three men above 60 years have BPH. However, the chances are even more as men grows older, hence 80% of men above 80 years have chances of BPH.  When Prostate gets larger it generates pressure on urethra because of which the urethra narrow down .  In Ayurveda this pathology has been considered with its clinically simulate ‘’VATASTHEELA”, A diseases which occurs in between the Gudsthana and basti just like a granthi (which is unnat ,achala and hard like ashthi). This granthi formation initiates the avarodh in normal pravritti of vishtha , mutra, apan vayu and ultimately causes of pain and other clinical pathologies in Basti Pradesh.

REVIEW OF LITERATURE
शकृ न्मार्गस्यबस्तेश्च वायुरन्तरमाश्रितः |अष्ठीलावद्धनंग्रन्थंकरोत्यचलमुन्नतम्||७|| श्रवण्मूत्राश्रनलसङ्गश्च तत्राध्मानं च जायते|वेदना च परा बस्तौ वाताष्ठीलेश्रत तांश्रवदुः ||८||SU.U.58

DRUG REVIEW Punarnavadi Kashaya  Sarangdhara madhyama khanda 76-77/2 पाण्डुशोथादौ पुनननवाददक्वाथः पुनननवाऽभयादनम्बदावीदिक्तापटोलक  ७८ गुडू चीनागरयुि  क्वाथो गोमूत्रसंयुिः पाण्डुकासोदरश्वासशूलसवानङ्गशोथहा ७९

ANUVASANA BASTI Taila Quantity Varunadhi Ghrita 30 ml Dashamoola Taila 42 ml
 NIRUHA BASTI Madhu 50 ml Lavana 10 gm Sneha Dashamoola Taila  30ml Gomutra 50ml Kalka Total 35gm Satpushpa 10 gm Punarnava 10 gm Gokshur  10gm Yava Kshara  5gm Kwatha Punarnava Kashaya and Ashmarihara Kashaya  200 ml

PREVIOUS WORK DONE  Vd.Sarveshkumar Role of Uttarbasti in the management of BPH; BHU, 2001  Vd.N.H. Kulkarni A clinical study on the role of devdarvyadi kashaya and dashmoolasiddha taila Uttar basti in the management of Mootraghata w.s.r. to BPH;Jamnagar,2002  Randomised controlled clinical trial of Narayan taila Uttatbasti in Vatastheela with special reference to benign prostatic hyperplasia;MUHS,2016  Dr.Shailesh jaiswal  A clinical case study on Dhanyak Gokshura Ghrita Yavakshar Uttar basti in the management of Mutraghata w.s.r. to BPH,2021

AIM  To compare the efficacy of Mahanarayana taila Uttarbasti and Punarnavadi Kashaya Yoga Basti in the management of “Vatastheela” with special reference to Benign Prostatic Hyperplasia (BPH). 

OBJECTIVES  To observe the symptomatic relief in Vatastheela using Mahanarayana Taila as Uttar Basti and Punarnavadi Kashaya as Yoga Basti together.  To observe the symptomatic relief in Vatastheela using only Punarnavadi Kashaya as Yoga Basti only. 

METHOD OF COLLECTION OF DATA  Sample size: 40 patients.  Study Design: Open Randomised Intervention Study.  Study Period: 28 days

Treatment Duration: 8 days.  20 patients allocated to each group, evenly dividing the participants into two groups 

 STUDY DURATION  Study time of 8 Days  Follow up period time  28 Days on 7th,14th,21st,28th day

INVESTIGATIONS  Hematological  CBC,  Serum Creatinine ,  Blood Urea , Serum PSA  Urological  Urine Routine & Microscopic  Radiological  Ultra sonography Of Pelvis Uroflowmetry 

RESCUE MEDICINE  Antibiotics , Alkalizer

ETHICAL CLEARANCE  It will be obtained from the institutional ethical committee of Parul university  Study will be registered in clinical trial registry of India (CTRI).   
 
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