| CTRI Number |
CTRI/2025/08/093498 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Parasurgical procedure of Preputial Dilatation in Phimosis |
|
Scientific Title of Study
|
Assessment of Effect of Parasurgical procedure of Preputial Dilatation in Niruddha Prakash w.s.r.t. Phimosis : An Open 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 |
Dr Rushikesh Subhash Late |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
ymt ayurved and medical college and hospital |
| Address |
opd no 4, shalyatantra departm
ent, ymt ayurved medical college and hospital, sector 4, kharghar, navi mumbai. 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9175758887 |
| Fax |
|
| Email |
laterushikesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpak Sunil Sadgune |
| Designation |
Associate professor |
| Affiliation |
ymt ayurved and medical college and hospital |
| Address |
opd no 4, shalyatantra departm
ent, ymt ayurved medical college and hospital, sector 4, kharghar, navi mumbai. 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9503448573 |
| Fax |
|
| Email |
shilpak.sadgune999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpak Sunil Sadgune |
| Designation |
Associate professor |
| Affiliation |
ymt ayurved and medical college and hospital |
| Address |
opd no 4, shalyatantra departm
ent, ymt ayurved medical college and hospital, sector 4, kharghar, navi mumbai. 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9503448573 |
| Fax |
|
| Email |
shilpak.sadgune999@gmail.com |
|
|
Source of Monetary or Material Support
|
| ymt ayurved and medical college and hospital, sector 4, kharghar , Navi Mumbai 410210 District- Raigarh Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Rushikesh Subhash Late |
| Address |
opd no 4, shalyatantra department, ymt ayurved mrdical college and hospital, kharghar ,navi mumbai |
| Type of Sponsor |
Other [self funding] |
|
|
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 Rushikesh Subhash Late |
ymt ayurved and medical college and hospital |
shalyatantra opd , room no 4,sector 4, kharghar, navi mumbai 410210
Raigarh
MAHARASHTRA |
9175758887
laterushikesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N471||Phimosis. Ayurveda Condition: NIRUDDHAPRAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | preputial dilatation | (Procedure Reference: sushrut samhita, Procedure details: Procedure Reference: , Procedure details: in pt of phimosis age group 1 to 14 were selected for preputial dilatation using mosquito & sinus forceps respectively duration: procedure will be done on first day ))
|
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Male |
| Details |
patient with congenital phimosis |
|
| ExclusionCriteria |
| Details |
pathological phimosis
Congenital abnormality like hypospadiasis, Epispadiasis
Patients with HIV, HbsAg, HCV positive
Congenital kidney disorder, Juvenile diabetes.
Patient suffering with severe systemic disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of preputial dilatation in niruddha prakash w.s.r.t. phimosis
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reliability of preputial dilatation in niruddha prakash w.s.r.t. phimosis |
DURATION OF STUDY: 30 days
PREPUTIAL DILATATION ON: Day 0
CLINICAL ASSESSMENT DONE ON: 0,1st, 4th
,7
th & 30th day |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
02/09/2025 |
| 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="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
|
TITLE- Assessment of effect of parasurgical procedure of Preputial Dilatation in Niruddha Prakash w.s.r.t. Phimosis: an open clinical trial
SAMPLE SIZE - TOTAL - 41 MODE OF ADMINISTRATION - PARASURGICAL PROCEDURE
PROCEDURE- under aseptic precaution, the preputial skin is cleaned with betadiene. xylocaine jelly 2% is applied to prepuce. the pinpoint opening is gradually dilated using lubricated mosquito and sinus forceps i vertical and horizontal direction until glans fully exposed by separating adhesions up to corona. xylocaine jelly is reapllied to the sxposed glans.
SCHEDULE - done only on first day
DURATION - 30 day
FOLLOW UP - Before procedure, after procedure, on 1st day , 7 and 30 day
Study centre - DR G D Pol Foundation YMT Ayurvedic medical college and hospital kharghar, navi mumbai
PG Scholar- DR RUSHIKESH SUBHASH LATE
Guide - DR SHILPAK SADGUNE ASSOCIATE PROFE. SHALYATANTRA DEPARTMENT
|