| CTRI Number |
CTRI/2026/03/106333 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
MANAGEMENT OF URETHRAL STRICTURE |
|
Scientific Title of Study
|
PROSPECTIVE DOCUMENTATION OF UTTARBASTI IN THE MANAGEMENT OF URETHRAL STRICTURE |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S N Pandey |
| Designation |
Ayurved physician |
| Affiliation |
Ujjain Panchakarma centre |
| Address |
Room No.1,Ground floor, Department of Panchakarma,Ujjain Panchakarma Centre, K 1/7 MIG, Rishi Nagar, Ujjain
Room No. 1, Ground Floor,
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
9425091185 |
| Fax |
|
| Email |
ujnpanchkarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Mangal |
| Designation |
Research Officer Ayurveda S 4 |
| Affiliation |
CCRAS-Regional Ayurveda Research Instituite |
| Address |
Room No.6, Regional Ayurveda Research Institute, Amkho, Gwalior
Regional Ayurveda Research Institute, Hospital wing, Amkho Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9755412502 |
| Fax |
|
| Email |
dranilmangal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Mangal |
| Designation |
Research Officer Ayurveda S 4 |
| Affiliation |
CCRAS-Regional Ayurveda Research Instituite |
| Address |
Room No.6, Regional Ayurveda Research Institute,Amkho Gwalior
Regional Ayurveda Research Institute, Amkho, Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9755412502 |
| Fax |
|
| Email |
dranilmangal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, J L N Anusandhan Bhawan,61-65 Institutional Area,Janakpuri, west,Ministry of AYUSH ,Govt. of India, New Delhi-110059,India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
JLN Anusandhan Bhawan,61-65 Institutional Area, Opposite D Block,Janakpuri west, New Delhi,110059 India |
| Type of Sponsor |
Government funding agency |
|
|
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 S N Pandey |
Ujjain Panchkarma Centre |
Room No. 1, Ground floor, K 1/7,MIG,Rishi Nagar, Ujjain-456010
Ujjain
MADHYA PRADESH |
9425091185
ujnpanchkarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics commiittee,Gwalior |
Approved |
| NoC from Ujjain panchakarma centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N359||Urethral stricture, unspecified. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kshar tail, Reference: Ayurved sar sangrah, Route: Urethral, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18 to 65 Years
Gender: Male and Female
Willing to participate
Clinical symptoms of Urethral stricture |
|
| ExclusionCriteria |
| Details |
BPH, Calculus in Urethra, and Atonic Bladder patients will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in Uroflowmetry |
at baseline, at 21 day and at the end of follow up after 180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in clinical symptoms
2.Change in USSIM score
3.Chane in SF-36 score |
at baseline, at 21 day and at the end of follow up after 180 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2026 |
| 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="6"
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
Modification(s)
|
| This is a single-arm study to document the role of Uttarbasti in the management of Urethral stricture (effectiveness, monitoring of AE/ADR, TEAE, Treatment compliance), and to document the pattern of use and clinical outcomes associated with Uttarbasti in the management of Urethral stricture. Symptom assessment: difficulty urinating, burning sensation during/after/before urination, decreased urine stream, Urge to urinate, spraying of the Urine stream.Assessment through RUG, Uroflowmetry and Urine routine and culture. Evaluation of patient-reported outcome measures using USSIM and SF-36 scores. The total study period will be 18 months with follow-up.
| |
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