| CTRI Number |
CTRI/2020/03/024091 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
13/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHILODBHIDADI TAILA MATRA BASTI IN THE MANAGEMENT OF VATASHTHILA WITH SPECIAL REFERENCE TO BENIGN PROSTATIC HYPERPLASIA(BPH) |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE EFFICACY OF SHILODBHIDADI TAILA MATRA BASTI IN THE MANAGEMENT OF VATASHTHILA WITH SPECIAL REFERENCE TO BENIGN PROSTATIC HYPERPLASIA(BPH) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ABHILASHA KORE |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL P.O. LIMDA PARUL UNIVERSITY
NIL
Vadodara
GUJARAT
391760
India |
| Phone |
7507797467 |
| Fax |
0 |
| Email |
abhilasha1214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHILASHA KORE |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL P.O. LIMDA PARUL UNIVERSITY
NIL
Vadodara
GUJARAT
391760
India |
| Phone |
7507797467 |
| Fax |
0 |
| Email |
abhilasha1214@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHILASHA KORE |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL P.O. LIMDA PARUL UNIVERSITY
NIL
Vadodara
GUJARAT
391760
India |
| Phone |
7507797467 |
| Fax |
0 |
| Email |
abhilasha1214@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVED |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL P.O. LIMDA PARUL UNIVERSITY 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 MUKUND DHULE |
PARUL AYURVED HOSPITAL |
SHALYATANTRA DEPARTMENT, SECOND FLOOR
Vadodara
GUJARAT |
8379017299
drmukunddhule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH, PARUL INSTITUTE OF AYURVED |
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 |
SHILODBHIDADI TAILA |
SHILODBHIDADI TAILA MATRABASTI 72ML FOR 7 DAYS AFTER FOOD OD |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
PATIENTS HAVING THE SIGNS AND SYMPTOMS OF VATASHTHILA (BPH) |
|
| ExclusionCriteria |
| Details |
PATIENTS BELOW 40 YRS OF AGE. SUFFERING FROM UROGENITAL DEFORMITIES AND ANY PELVIC PATHOLOGY. UNCONTROLLED HYPERTENSION AND DM. TUBERCULOSIS. PARALYSIS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SHILODBHIDADI TAILA MATRABASTI WILL BE EFFECTIVE IN THE MANAGEMENT OF VATASHTHILA |
SHILODBHIDADI TAILA MATRABASTI WILL BE EFFECTIVE IN THE MANAGEMENT OF VATASHTHILA WITHIN 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 |
|
Date of First Enrollment (India)
|
25/03/2020 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
NULL HYPOTHESIS ;- SHILODBHIDADI TAILA IS NOT EFFECTIVE IN THE MANAGEMENT OF VATASHTHILA ALTERNATE HYPOTHESIS :- SHILODBHIDADI TAILA IS EFFECTIVE IN THE MANAGEMENT OF VATASHTHILA |