| CTRI Number |
CTRI/2021/03/031681 [Registered on: 03/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of pashanabheda kashaya and paataladi kashaya in the management of Prostate. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Pashanabheda Kashaya And Paataladi Kashaya In The Management Of Vatashthila With Special Reference To Benign Prostatic Hyperplasia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivekanand Kullolli |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-106 parul institute of Ayurveda, department of shalya tantra Parul University Post-Limda Tal-Waghodia Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
vivekanandkullolli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitabh Bachchan Kumar |
| Designation |
P.G scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-106 parul institute of Ayurveda, department of shalya tantra Parul University Post-Limda Tal-Waghodia Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9449685098 |
| Fax |
|
| Email |
dr.amitabhsingh5098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitabh Bachchan Kumar |
| Designation |
P.G scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-106 parul institute of Ayurveda, department of shalya tantra Parul University Post-Limda Tal-Waghodia Vadodara GUJARAT 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9449685098 |
| Fax |
|
| Email |
dr.amitabhsingh5098@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dean Parul Institute of Ayurved |
| Address |
Parul Ayurved Hospital P.O Limda Parul University
Vadodara 391760 |
| 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 Amitabh Bachchan Kumar |
Parul institute of Ayurveda |
OPD-106 parul institute of Ayurveda, department of shalya tantra Parul University Post-Limda vadodara gujarat Vadodara GUJARAT
Vadodara
GUJARAT |
9449685098
dr.amitabhsingh5098@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:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paataladi kashaya |
first make the kashaya then give to the patient for drink |
| Intervention |
Pashanabheda kashaya |
first make the kasaya then give to the patient for drink |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
-Male aged between 40 to 85years
-Having clinical features of Vatashtila or BPH like
Granthivat
Adhmana
Mutrasangha
Basti vedana
Dribbling micturition
Nocturia
Increased frequency
Urgency
Weak stream
Intermittency
Straining
Sensation of incomplete emptying
|
|
| ExclusionCriteria |
| Details |
K/C/O uncontrol diabetic mellites,hypertension
•CA prostate
• Urethral stricture
•Bladder neck stenosis
•Neuropathy bladder dysfunction
•Impaired renal function
•Prostate (grade 4)
•Patient indicated for prostectomy
•Haematuria secondary to renal & bladder stone,
•Anaemic patient with Hb below 6 gm%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptoms like frequency, urgency, nocturia weakstream of urine etc |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms like frequency, urgency, nocturia weakstream of urine etc |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
10/03/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ø Benign prostatic hyperplasia involves the stromal and epithelial elements arising in periurethral and transitional zone of the gland. Ø The enlargement of prostate exerts pressure on prostatic urethra which produces obstructive urinary symptoms like increase frequency of urination, dysuria , urgency , dribbling of urine, nocturia etc. Ø Mutraghat is an important disease in group of Mutramaragrogas as described in Ayurvedic texts. Ø Benign prostatic hyperplasia is one of the most common obstructive Uropathy affecting the aging male. The term Mutraghata is derived from word Mutra and Aghata which means obstruction & suppresion of urine outflow. |