| CTRI Number |
CTRI/2023/08/056112 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
DURVA TAILA IN URETHRAL STRICTURE |
Scientific Title of Study
Modification(s)
|
EFFICACY OF DURVA TAILA UTTARBASTI IN THE MANAGEMENT OF STRICURE URETHRA AN OPEN LABELLED CLINICAL STUDY |
| 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 IMRANNABI JABBARALI NADAF |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL INSTITUTE OF AYURVED
OPD NO 106
DEPARTMENT OF SHALYATANTRA
LIMDA VADODARA 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9834381686 |
| Fax |
|
| Email |
imran.nadaf78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMANT TOSHIKHANE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL INSTITUTE OF AYURVED
OPD NO 106
DEPARTMENT OF SHALYATANTRA
LIMDA VADODARA 391760
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 |
PARUL INSTITUTE OF AYURVED
OPD NO 106
DEPARTMENT OF SHALYATANTRA
LIMDA VADODARA 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
Drhemantt@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVED
OPD NO 106 DEPARTMENT OF SHALYATANTRA LIMDA VADODARA 391760 |
|
|
Primary Sponsor
|
| Name |
DR IMRANNABI JABBARALI NADAF |
| Address |
PARUL INSTITUTE OF AYURVED
OPD NO 106 DEPARTMENT OF SHALYATANTRA LIMDA VADODARA 391760 |
| Type of Sponsor |
Other [SELF] |
|
|
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 IMRANNABI JABBARALI NADAF |
PARUL AYURVED HOSPITAL |
PARUL INSTITUTE OF AYURVED
OPD NO 106 DEPARTMENT OF SHALYATANTRA LIMDA VADODARA 391760
Vadodara
GUJARAT |
9834381686
imran.nadaf78@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: MUTRA-VEGARODHAH/MUTRAGRAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: SAHASRA YOGA TAILA VARGA, Procedure details: UTTARBASTI WITH DURVA TAILA DAILY ONCE A TIME)
(1) Medicine Name: DURVA, Reference: SAHASRA YOGA TAILA VARGA, Route: Urethral, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Stricture Urethra will be included
Patients of either gender of age 25 TO 75years with history of stricture urethra of mild to moderate symptoms will be selected for the study
|
|
| ExclusionCriteria |
| Details |
Age group below 25 years and above 75 years
Patients of impacted calculus in the urethra and bladder Neck
Benign Prostatic Hyperplasia
Uncontrolled Diabetes Mellitus
Nephritic Syndrome and Neoplasm of lower urinary tract
Congenital and severely symptomatic Stricture Urethra
HIV and HbsAg positive
Carcinoma patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WILL REDUCE THE SYMPTOMS OF URETHRAL STRICTURE EG DRIBBLING MICTURITION URINE STREAM WITHIN 7 DAYS WITH UTTARBASTI |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVE THE QUALITY OF LIFE AND REDUCE SYMPTOMS OF URETHRAL STRICTURE |
7 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 3 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2023 |
| 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)
|
Not Yet Recruiting |
| 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
|
AIM
•To compare
clinical efficacy of Durva
tailauttarbastiin the management of urethral stricture.
OBJECTIVES
• To PrepareDurva Taila.
• To study the effect of DurvaTailaUttarbasti
in improving the subjective symptoms of urethral stricture.
• Analysis of Durva Taila in wound healing by HPTLC method.
To attain the probable mode of action of effect of Durva Taila in
Urethral stricture |