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CTRI Number  CTRI/2025/05/086366 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   role of Uttarbasti in Mutrakruccha Urethral Stricture 
Scientific Title of Study   A Clinico Comparative Study Of Shwadamstradi Taila Uttarbasti With And Without Matrabasti In The Management Of Mutrakruccha With Special Reference 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  Pranit R Nachan 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurved College Ahmedabad 
Address  Government Akhandanand Ayurved College and Hospital Ahmedabad
Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College and Hospital Ahmedabad
Ahmadabad
GUJARAT
380001
India 
Phone  9511650880  
Fax    
Email  pranitnachan4836@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh kumar Sharma 
Designation  Professor and HOD 
Affiliation  Government Akhandanand Ayurved College Ahmedabad 
Address  Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College Ahmedabad

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 and HOD 
Affiliation  Government Akhandanand Ayurved College Ahmedabad 
Address  Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College Ahmedabad


GUJARAT
380001
India 
Phone  9408205584  
Fax    
Email  dr.rajeshsharma38@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India 
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College and Hospital  
Address  Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India 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 
Dr Pranit R Nachan  Government Akhandanand Ayurved College and Hospital  Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College and Hospital
Ahmadabad
GUJARAT 
9511650880

pranitnachan4836@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
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Sushrut uttartantra 59th chapter 17th shloka, Procedure details: Preparation of the patient Take written informed consent of patient Patient advised to empty bladder prior to the procedure of Uttarbasti Local Abhyanga Swedana to be done prior to Uttarbasti Painting and draping properly Procedure will be performed in the morning after complete digestion of the previous meal. INSTRUMENTS Disposable syringe 20 ml capacity 10 percent betadine solution 2 percent Lignocaine jelly Sponge holding forceps Sterile hole sheet Cotton and gauze pads Surgical Gloves Surgical mask and gown All the instruments to be properly sterilized and the procedure to be conducted in the operation theater under strict aseptic measures. DOSE 20 ml DURATION One time per day for 21 days means 3 cycle in which one cycle Uttarbasti for 3 days than 4 days gap between two cycles Instillation of medicated Taila into bladder constitute of Pradhan karma The patient should made supine position on OT table. Taila will be made luke warm by keeping it into luke warm water. The Syringe tip will to be introduced in the Urethra and 20 ml Taila to be pushed. Penile clamp will be used for better effect. PASCHAT KARMA Patient advised to relax for 30 min in the bed and hot water bag to be given. Patient advised to take plenty of liquids especially hot water buttermilk barley water through the day)
(1) Medicine Name: Shwadamstradi Taila, Reference: Sushrut Uttartantra 59th chapter 19th shloka, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 12 Days
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः with maatrabasti (Procedure Reference: Charak Chikitsa 26th chapter 58 shloka, Procedure details: 9 days uttarbasti with 4 days gap and maatrabasti for 12 days continuously)
(1) Medicine Name: Shwadamstradi Taila, Reference: Sushruta Uttar Tantra 59 chpter 19th shloka, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 9 Days
(2) Medicine Name: Shwadamstradi Taila, Reference: Sushruta Uttar Tantra 59 chpter 19th shloka , Route: Rectal, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 12 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient selected irrespective of their Religion, Cast, Gender without any bars

Age between 18 to 60 years

Controlled case of Diabetes with HbA1C less than 7 percentage and Hypertension with BP less than 150 systolic and 90 diastolic

Patient having sign &symptoms of Mutrakruccha 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 Atonic Bladder
Patient with systemic disease like Asthma Epilepsy Autoimmune disorders Multiple Sclerosi Heart Disease

Uncontrolled case of Diabetes with HbA1C more than 7percentage and Hypertension with BP more than 150 systolic and 90 Diastolic

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 
Improvement in patients signs and symptoms like reduced Frequency of micturition and Reduced pain while micturition  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
which procedure is more helpful in relieving the symptoms of mutrakruccha  2 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/06/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Stricture urethra though a rare condition still is a rational and troublesome problem in the international society. There is marked increase in incidence starting at the age of 55 years. Studies have suggested that men appear to be at more risk than that of females as they have longer urethra. Worldwide it is estimated that male urethral strictures have a prevalence of The etiology of urethral strictures is divided into 4 major groups Idiopathic Iatrogenic inflammatory and Post traumatic. Urethral stricture may present in the of range of manifestations from an asymptomatic presentation to severe discomfort secondary to urinary retention .It is common condition resulting in many office appointments emergency room visits and hospital admissions with the estimated rate around 1 to 9 strictures per 1000 people in India.
Stricture usually arising from prolonged catheterization radiation BPH prostatic and trans urethral surgery repeated UTI and STD.  Approximately 30 percent of urethral strictures are idiopathic and most common causes of urethral stricture today are traumatic or iatrogenic. Iatrogenic urethral trauma usually results from improper or prolonged catheterization and accounts for 32 percent of strictures. Some patients may choose to manage their stricture disease with periodic urethral dilations. The goal is to stretch the scar without producing additional scarring. It may be curative in patients with isolated epithelial strictures means no involvement of corpus spongiosum. Most of the time urethral stricture is seen in elderly population with a marked increase after 55years of age. Urethral stricture disease is still a prevalent problem with an estimated incidence of 0.6 percent in susceptible population. In patients with urethral stricture disease older than 60 years 6.5percent  underwent retrograde urethrography RUG studies. Urethral dilation remains a very common outpatient procedure among Medicare beneficiaries. Patients with urethral stricture are considered a vulnerable population as they experienced high rates of UTIs and incontinence  as sequelae of the disease. 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. Acharya sushruta mentioned Ghrita and Taila Uttarbasti in management of the Urethral stricture.  In Uttarbasti Drug reduce the fibrosis in stricture part of urethra. Matrabasti Drug pacifies the pain particularly at the perineal region as the Mutravaha Srotasa become free from vitiated Vata. By keeping mentioned things at point of convergence shwadamstradi taila Uttarbasti with and without Matrabasti is selected for the management of Mutrakruccha with special reference to urethral stricture. Though there are multi folded treatment modalities exists in western medical science they are having own advantages and disadvantages so there was an intense and persistant scope to find out simple and easily available treatments for relieving painful micturition by increasing constricted urethral lumen diameter without any adverse effect. Uttarabasti a para surgical procedure is the most effective available treatment in Ayurveda for the diseases of Mutravaha Strotas. In Mutrakruccha there is vitiation of Vata especially Apan vayu which is located at Shroni Basti  Medhra leads to obstruction of urine outflow due to this Vimargagamana and Marga Avrodhan occurs. Therefore 
main principle should be to Vatanuloman and Mutrashodhan to return the normal qualities of Apan Vayu. Medicated oil prepared out of Gokshur swarasa Gud Kshir Shunthi which are prepared by Tailapak method.Due to this Sanga gets removed from Mutravaha Strotasa particularly at the urethra leading to increase in size of the lumen which was constricted previously diameter at the site of stricture. As the Mutravaha Strots become free from the vitiated Vata. considering all the views Shwadamstradi taila
Uttarbasti with and without Matrabasti has been selected for the management of Mutrakruccha with special reference  to Urethral Stricture.
 
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