| CTRI Number |
CTRI/2019/05/019178 [Registered on: 16/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Prostatomegaly through Ayurveda |
|
Scientific Title of Study
|
Clinical study of Dhanyaka Gokshuradi Ghrita Kshar Basti in the management of Vatashtila w.s.r. to Benign Prostatic Hyperplasisa (BPH) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drshailesh kumar Rameshlal Jaiswal |
| Designation |
Ph.D scholar and Assistant professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD No.116,Parul Institute of Ayurved Parul Ayurveda Hospital Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9978608907 |
| Fax |
|
| Email |
shailesh.skp61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant D Toshikhane |
| Designation |
Dean,Faculty of Ayurveda |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD No.116,Parul Institute of Ayurved Parul Ayurveda Hospital Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drshailesh kumar Rameshlal Jaiswal |
| Designation |
Ph.D scholar and Assistant professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD No.116,Parul Institute of Ayurved Parul Ayurveda Hospital Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9978608907 |
| Fax |
|
| Email |
shailesh.skp61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital Limda
Tal Waghodia Dist Vadodara 391760 Gujarat |
|
|
Primary Sponsor
|
| Name |
Shalya Tantra Department |
| Address |
OPD No.116,Parul Institute of Ayurved Parul Ayurveda Hospital Parul University Limda Vadodara |
| 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 |
| Dr Shailesh kumar Jaiswal |
Parul Ayurveda Hospital |
OPD No.116,Parul Institute of Ayurved Parul Ayurveda Hospital Parul University Limda Vadodara
Vadodara
GUJARAT |
9978608907
shailesh.skp61@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Uttarbasti |
Dhanyak Gokshur Ghrita with kshar 30 ml per day for 7 days
through Urethral Route |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
-Patient fulfilling diagnostic criteria
-Patients having the sign and symptoms of vatasthila ( BPH)
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from malignancy, congenital deformities of urogenital tract or any other pelvic pathology.
2) Uncontrolled Hypertension
3) Tuberculosis (TB)
4) Paralysis
5) Parkinsonism etc.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in clinical symptoms |
7 sitting of uttarbasti once daily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Size reduction of Prostate gland |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/05/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are multi
folded conservative treatment modalities are available from modern medical
science with its own advantages and disadvantages. Therefore, there is an
intense and persistent scope to find out a simple medicine for relieving
obstructive uropathy by reducing the size of the prostate gland and enhancing
the tone of urinary bladder musculature without adverse effect. Hence keeping
this thing in view, Dhanyaka-Gokshur Ghrita kshar for Uttarbasti
have been selected for management of vatasthila(BPH). |