| CTRI Number |
CTRI/2018/04/013033 [Registered on: 04/04/2018] Trial Registered Prospectively |
| Last Modified On: |
04/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on role of Ayurvedic treatment in the management of urinary tract disease |
|
Scientific Title of Study
|
A CLINICAL STUDY ON JĀTYĀDI TAILA UTTARABASTI IN THE MANAGEMENT OF MŪTRAKṚCCHRA W.S.R. URETHRAL STRICTURE IN MALE |
| Trial Acronym |
with special reference |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dalvadi Jagdishchandra Kalidas |
| Designation |
PG scholar |
| Affiliation |
J.S.Ayurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya college road nadiad
Panchkarma Department,P.D.Patel Ayurvedic Hospital, college road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8088161166 |
| Fax |
|
| Email |
jagdishdalvadiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD |
| Affiliation |
J.S.Ayurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya college road nadiad
P.D.Patel Ayurvedic hospital Panchkarma Department college road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dalvadi Jagdishchandra Kalidas |
| Designation |
PG scholar |
| Affiliation |
J.S.Ayurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya college road nadiad
Panchkarma Department, P.D.Patel Ayurvedic hospital, college road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8088161166 |
| Fax |
|
| Email |
jagdishdalvadiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurvedic Pharmacy and P D patel ayurvedic hospital, College Road, Nadiad 387001. |
|
|
Primary Sponsor
|
| Name |
JSAyurveda Mahavidyalaya |
| Address |
J.S.Ayurveda Mahavidyalaya college road nadiad |
| 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 |
| Dalvadi Jagdishchandra k |
P D Patel Ayurveda Hospital |
Panchkarma Department, P D Patel Ayurveda Hospital
college road Nadiad 387001
Kheda
GUJARAT |
8088161166
jagdishdalvadiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male patients of urethral stricture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jatyadi Taila uttarbasti |
With proper precautions 2 ml sterilized jatyadi taila will be pushed at the beginning of the urethra through rubber catheter once a day till 21 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Male patients having confirmed diagnosis of urethral stricture will be include
patients having more than 18 years of age will be selected |
|
| ExclusionCriteria |
| Details |
Patients of impacted calculus in the urethra and/or bladder neck, uncontrolled diabetes mellitus, neoplasm of lower urinary tract, human immunodeficiency virus (HIV) reactive and hepatitis B surface antigen (HbsAg) reactive patients will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of ayurvedic management in the patients of urethral stricture in male |
effect of ayurvedic management in the patients of urethral stricture in male in 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
05/04/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable. This thesis work will yet to be submit. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A clinical evaluation of effectiveness of Ayurvedic Management in urethral stricture in male is the main object of study. Patients will be selected from P.D.Patel Ayurvedic Hospital, Nadiad after the confirmation of the patient of the urethral stricture with the help of classical sign and symptoms , they will treated with following therapy · 2ml of sterilized jÄtyÄditaila will be filled in the syringe through rubber catheter attached to it. · Catheter will be introduced in the urethra and jÄtyÄditailawill be pushed at the beginning of the urethra once a day till 21 days. · Rubber catheter will be introduced more deep in the urethra progressively up to the stricture with continuous push of jÄtyÄditaila through it. |