| CTRI Number |
CTRI/2025/03/082149 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of urethral dilatation and use of moolak tail on urethral stricture |
|
Scientific Title of Study
|
Exploratory study to evaluate the efficacy of uttarbasti using moolak taila and urethral dilatation in 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 Ankit Redu |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
| Address |
PG Department of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7737201600 |
| Fax |
|
| Email |
reduankit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Prof and HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
| Address |
PG Department of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Prof and HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
| Address |
PG Department of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
| Address |
PG Department of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ankit Redu |
PG Department of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit Redu |
Sanjeevani Chikitshalya Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University jodhpur |
Room No 14 PG Department of Shalya tantra Sanjeevani Chikitshalya Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037
Jodhpur
RAJASTHAN |
7737201600
reduankit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N350||Post-traumatic urethral stricture. Ayurveda Condition: VATAKUNDALIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: cha. si. 9/49, Procedure details: 2 ml each of Moolak taila will be administered after step bystep urethral dilatation with semi
flexible boogies for 2 months in an interval of 1 week)
(1) Medicine Name: Moolak Tail, Reference: cha. chi. 28/172, Route: Urethral, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
A substantial hemorrhage into the urinary tract.
Pain and inflammation in the urethra.
Patients who will give written consent.
Patients with classical signs and symptoms of urethral stricture will be included in the trial. |
|
| ExclusionCriteria |
| Details |
Urethral diverticulum.
Periurethral abscess.
Urethral fistula.
Urinary tract infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreased urine stream.
Incomplete bladder emptying.
Spraying of the urine stream.
Difficulty, straining or pain when urinating.
Increased urge to urinate or more-frequent urination.
Burning sensation |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Retention of urine due to urethral stricture.
Urethral catheter is not passing easily.
Investigate patients as per requirement of ascending urethrogram |
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)
|
07/04/2025 |
| 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
|
This is single group an exploratory study of Moolak Tail
Uttarbasti And Urethral Dilatation In Vatakundal (Urethral Stricture). Patients
age having URETHRAL STRICTURE diagnosed by Ascending Urethrogram and classical
signs and symptoms of urethral stricture will be included in the trial and
Patients having age group 18 years to 80 years. Patient suffering
from Hepatitis B, sexually transmitted diseases, human immunodeficiency virus
(HIV), Urethral diverticulum, Periurethral abscess, Urethral fistula, Congenital
anatomical defect of urethra and Contraindication of Uttar Basti (like Genital
tract infection, heavy bleeding, etc.) are excluded. 2 ml of Moolak taila will
be administered after step by step urethral dilation with semi flexible boogies
for 2 months in an interval of 1 week. |