| CTRI Number |
CTRI/2025/10/096225 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of uttarbasti and dilatation in the management of urethral stricture |
|
Scientific Title of Study
|
An Open Label Perspective Clinical Study To Evaluate Composite Effect Of Uttarbasti
With Urethral Dilatation in The Management of Urethral Stricture |
| 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 Ketul Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403 Department of Shalyatantra Parul Institute of Ayurved Parul University Post Limda Waghodia Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
7984706269 |
| Fax |
|
| Email |
ketulpatel01999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403 Department of Shalyatantra Parul Institute of Ayurved Parul University Post Limda Waghodia Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403 Department of Shalyatantra Parul Institute of Ayurved Parul University Post Limda Waghodia Vadodara Gujarat 391760 India
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurved , Parul University, AP-Limda,TAL-Waghodia,Vadodara,Gujarat,India-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Faculty of Ayurved,Parul University,AP-Limda,TAL-Waghodia,Dist-Vadodara,Gujarat,India-391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketul Patel |
Parul Ayurved Hospital |
OPD No 106 Department of Shalyatantra Parul Institute of Ayurved Parul University Post Limda Waghodia Vadodara Gujarat 391760 India
Vadodara
GUJARAT |
07984706269
ketulpatel01999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL INSTITUTE OF AYURVED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N359||Urethral stricture, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Sushruta Samhita Uttartanta Chapter 59, Procedure details: 50 ml Taila will be loaded in the syringe
The Foleys adaptor will be attached to the tip of the syringe
The tip of the Foleys adaptor will be introduced gently into tip of the urethra and 50 ml Taila to be pushed very slowly
Urethral Dilatation Procedure
On the specified days, dilatation of the urethra will be performed using specific urethral dilators
First Lignocaine 2 percentage gel will be introduced into the urethra
Next the specific urethral dilators will be gently inserted
)
(1) Medicine Name: Tila Taila , Reference: Bhavprakash Nighantu Taila Varga, Route: Urethral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have diagnosed with urethral stricture
Controlled case of diabetes mellitus (Hba1c less than 7% & RBS less than 180 mg/dl) and Hypertension is less than 150/90 mm Hg
|
|
| ExclusionCriteria |
| Details |
Patients of impacted calculus in the urethra and bladder Neck
Benign Prostatic Hyperplasia
Nephrotic Syndrome and Neoplasm of lower urinary tract
Congenital Stricture Urethra
HIV and HbsAg positive
Patients with malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effect of uttarbasti with urethral dilatation in the management of urethral stricture.
To assess the safety and tolerability of uttarbasti with urethral dilatation in the management of urethral stricture. |
Intervention will be done for 15 Days.
Follow up will be done on 30th and 60th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve Quality of life |
60 days |
|
|
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)
|
30/10/2025 |
| 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="0"
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
|
Urethral stricture (Mutramarga Sankocha) is a chronic and recurrent narrowing of the urethral lumen due to fibrotic changes, leading to difficulty in micturition, straining, dribbling, and other lower urinary tract symptoms (LUTS). Conventional treatments such as urethral dilatation, Visual Internal Urethrotomy (VIU), and urethroplasty are often invasive and prone to recurrence. Ayurveda describes similar conditions under Mutrakruccha and Mutrotsanga, where Uttarbasti is mentioned as a prime therapeutic approach. The present open-labelled, single-arm, prospective clinical study is designed to evaluate the composite effect of Uttarbasti with Tila Taila (Sesamum indicum) in combination with urethral dilatation in the management of urethral stricture. The study will be conducted in the Department of Shalya Tantra, Parul Institute of Ayurved, Parul University, Vadodara, Gujarat. Thirty patients fulfilling inclusion and exclusion criteria will receive Uttarbasti with 50 ml of sterile Tila Taila administered per urethra once daily for 15 days, along with urethral dilatation on the 5th, 7th, 9th, and 11th days. The primary objective is to evaluate the composite efficacy of Uttarbasti with urethral dilatation, while the secondary objectives are to assess safety, tolerability, and patient satisfaction. The effect will be assessed subjectively using patient-reported outcome measures (PROMs) and objectively through Retrograde Urethrogram (RGU) and uroflowmetry before and after treatment. The total study duration will be 60 days, including treatment and follow-up on the 30th and 60th day. |