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CTRI Number  CTRI/2024/05/067334 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 05/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the effect of Varun Taila Uttarbasti with and without Snehapana in the treatment of Mutrakrucchara (Urethral Stricture) 
Scientific Title of Study   A CLINICO-COMPARATIVE STUDY OF VARUN TAILA UTTARBASTI WITH AND WITHOUT SNEHAPANA IN THE MANAGEMENT OF MUTRAKRUCCHRA W.S.R. TO URETHRAL STRICTURE -An open-label randomized comparative clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajaneekant Rameshbhai Panchal 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 24 Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  7874988749  
Fax    
Email  rajaneekantpanchal007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumar Sharma 
Designation  Professor & HOD 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 24 Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9408205584  
Fax    
Email  dr.rajeshsharma38@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Kumar Sharma 
Designation  Professor & HOD 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 24 Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9408205584  
Fax    
Email  dr.rajeshsharma38@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India 
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College and Hospital 
Address  Department of Shalya Tantra OPD No 24 Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India 
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 
Rajaneekant Rameshbhai Panchal   Government Akhandanand Ayurved College and Hospital  Department of Shalya Tantra OPD No 24 Government Akhandanand Ayurved College and Hospital Ahmadabad Gujarat 380001 India
Ahmadabad
GUJARAT 
7874988749

rajaneekantpanchal007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE , Government Akhandanand Ayurved College, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N359||Urethral stricture, unspecified. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: CA.CHI.26/45, Procedure details: UTTARBASTI 21 DAYS (3 CYCLES- 3 DAYS UTTARBASTI IN 1 CYCLE AND 4 DAYS GAP IN TWO CYCLES) WITHOUT SNEHAPANA))
(1) Medicine Name: VARUN TAILA, Reference: BHA.MA.37/58, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 21 Days
2Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: CA.CHI.26/45, Procedure details: SNEHAPANA CONTINOUS 21 DAYS (20 ML) WITH UTTARBASTI 21 DAYS (3 CYCLES- 3 DAYS UTTARBASTI IN 1 CYCLE AND 4 DAYS GAP IN TWO CYCLES))
(1) Medicine Name: SHWADAMSTRADI GHRITA, Reference: CA.CHI.26/74, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 21 Days
(2) Medicine Name: VARUN TAILA, Reference: BHA.MA.37/58, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with age between 18 to 60 years
Controlled case of Diabetes and Hypertension
Patient having sign and symptoms of Mutrakrucchra (Urethral Stricture) fulfilling
diagnostic criteria will be included 
 
ExclusionCriteria 
Details  Patient below the age of 18 years or above the age of 60 years
Patient have impacted calculus in the urethra and urinary bladder neck Benign
Prostatic Hyperplasia Nephrotic syndrome and Neoplasm of lower urinary tract UTIs
Patient with systemic disease like Asthma Epilepsy Autoimmune disorders Multiple Sclerosis Heart Disease
Uncontrolled case of Diabetes and Hypertension
Patient with HIV HBsAg STDs
Patient with malignancy will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Result will be assessed on the basis of relief in painful micturition and improvement in urine flow in Mutrakrucchra  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Which procedure is more helpful in relieving the symptoms of Mutrakrucchra  2 Months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/05/2024 
Date of Study Completion (India) 31/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
A CLINICO-COMPARATIVE STUDY OF VARUN TAILA UTTARBASTI WITH AND WITHOUT SNEHAPANA IN THE MANAGEMENT OF MUTRAKRUCCHRA W.S.R. TO URETHRAL STRICTURE -An open-label randomized comparative clinical trial

INTRODUCTION:

·       Urethra, a tubular passage, is the organ of body which carries urine and seminal fluid in males and only urine in females.

·       Urethral stricture is a narrowing of the urethra due to scar tissue, which leads to obstructive voiding dysfunction with potentially serious consequences for the entire urinary tract.

·       The consequences of this obstruction can extremely impair the patient’s quality of life by causing micturition disturbances and resulting in loss of renal functions.

·       Urethral strictures are more common in men because their urethra is longer than those in women. Thus, men’s urethra is more susceptible to disease or injury.

·       In classical ayurvedic texts, the disease, in which patient feels difficulty in micturition is consider as Mutrakrucchra.

WHY THIS TOPIC SELECTED?

·        In modern surgery effective therapy has been establish for the condition but more recurrences and complications. The discussion on surgical techniques and diagnostic methods of one of the oldest pathologies known to the urologist is still continuous. Thus, the urethral stricture remains a challenging pathology today. Hence there is need to find other treatment option for urethral stricture.

·    In Ayurveda Mutrakrucchra caused by vitiated Vata dosa especially with its Ruksha Guna; hence Treatment of Vata dosa with Snigdha Guna dominant Dravya can reduce it.

·       Taila considered best among Vata pacifying Dravya and it is one of the Uttama Sneha.

There is a reference that in Mutrakrucchra treatment should be planned according to  Vatasthan and for Vatasthan - Basti is a choice of treatment hence Uttarbasti is selected for Mutrakrucchra.

Acharya Charak also mentioned Uttarbasti and Snehapana in the treatment plan of Vataja Mutrakrucchra.

·       In Uttarbasti, Drug reduce the fibrosis in stricture part of urethra. In Snehapana, Drug reduce the Sanga from Mutravaha Srotasa, particularly at the urethra. As the Mutravaha Srotasa become free from vitiated Vata, considering all the views Varun Taila for Uttarbasti and Shwadamstradi Ghrita for Snehapana has been selected for the treatment in the patients of Mutrakrucchra.


NEED OF PRESENT STUDY:

·       Urethral stricture is common urological problem of people due to lack of any kind of successful western medication there is intense and persistent scope to find out a simple medicine for relieving in the symptoms without any adverse effect on the urethra or urogenital tract.

·       According to above keeping in the view Varun Taila for Uttarbasti and Shwadamstradi Ghrita for Snehapana has been selected for the treatment in the patients of Mutrakrucchra (Urethral Stricture)


RESEARCH QUESTION:

·       Whether there is any significant difference between Varun Taila Uttarbasti with Snehapana and without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture?


AIM

• To assess the effect of Varun Taila Uttarbasti with Snehapana and without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture


OBJECTIVES: 

• To evaluate the efficacy of Varun Taila Uttarbasti with Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture
• To evaluate the efficacy of Varun Taila Uttarbasti without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture



DIAGNOSTIC CRITERIA

• Sign and Symptoms of Mutrakrucchra (Urethral Stricture) 
• Uroflowmetry 
• RGU (Retrograde Urethrogram) 
• USG-KUB if needed


STUDY DESIGN:

• Study Type : Open label randomized comparative clinical trial 
• No. of Groups : 2 (10 patients in each group) 
• Sample Size : 20 patients 
• Location of study : Study will be conducted at Government Akhandanand Ayurved Hospital and Maniben Ayurved Hospital


DETAILS OF INTERVENTIONS:

● Group A: Shwadamstradi Ghrita Snehapana followed by Varun Taila Uttarbasti in the management of Mutrakrucchra w.s.r. Urethral Stricture

● Group B: Varun Taila Uttarbasti without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture


OBJECTIVE CRITERIA of Assessment (Before & After treatment):

• Uroflowmetry 
• RGU ( Retrograde Urethrogram)

WITHDRAWL CRITERIA:

After the scheduled course, medicines will be withdrawn with proper consultation and future follow-up will be maintained
During the trial period, if any moderate to severe complications found, medication will be stopped

REPORTING ADR:

 Adverse Drug Reaction (ADR), if observed will be registered and reported to Peripheral Pharmacovigilance Centre (PPvC), GAAC, Ahmedabad


DECLARATION: 

The study will be completed in the stipulated time limit. 
The work will be carried out after getting clearance from the institutional ethics committee. 
The data related to the identification of the patient will be kept confidential. 
The clinical data obtained will be summarized at the end of the study

 














 
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