| CTRI Number |
CTRI/2020/11/029083 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Of Use Of Pashanbhedadi Ghanvati In The Treatment Of Enlargement Of Prostate. |
|
Scientific Title of Study
|
"RANDOMIZED CONTROLLED CLINICAL TRIAL OF EFFICACY OF PASHANBHEDADI GHANVATI IN THE MANAGEMENT OF VAATASHTHILA W.S.R. TO BENIGN PROSTATE HYPERPLASIA" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Popatrao Bhalke |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department of Shalyatantra
Government Ayurved College and Hospital Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
7083454073 |
| Fax |
|
| Email |
preetibhalke2095@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R H Amilkanthawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
Government Ayurved College And Hospital Nanded |
| Address |
Department of Shalyatantra
Government Ayurved College and Hospital Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R H Amilkanthawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
Government Ayurved College And Hospital Nanded |
| Address |
Department of Shalyatantra
Government Ayurved College and Hospital Vazirabad Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital Nanded |
|
|
Primary Sponsor
|
| Name |
Preeti Bhalke |
| Address |
Shalyatantra department GOVERNMENT AYURVED COLLEGE AND HOSPITAL VAZIRABAD NANDED |
| Type of Sponsor |
Other [ Self] |
|
|
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 R H Amilkanthawar |
Government Ayurved College and Hospital Nanded |
OPD NO 6
Department of Shalyatantra
Government Ayurved Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA |
9890569621
drarajendrah@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: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Capsule Urimax |
Capsule Urimax 0.4mg 1 HS given to the patient after meals for 45 days |
| Intervention |
PASHANBHEDADI GHANVATI |
Pashanbhedadi Ghanvati 1gm BD giveng to the patient with normal water before meals for 45 days and assessment done on 15th 30th and 45th day |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patients having prostate size 30 to 100 gram
Patients having post void residual volume 50 to 200 ml
Patients willing to participate in study
Patients having mild 1 to 7 moderate 8 to 19 international prostate symptom score
Patients with severe 20 to 35 international prostate symptom score with no other consequences of benign prostate Hyperplasia and reluctant for surgery |
|
| ExclusionCriteria |
| Details |
Patients of malignant prostatic enlargement or prostatitis or uremia septicemia or renal failure
Patients having other urological pathologies like nephrotic syndrome or glomerulo nephritis or chronic kidney diseases etc
Increased serum creatinine and blood urea
Patients having HIV or HBsAg or major systemic disorders like uncontrolled HTN or DM or PTB etc
Patients participating in other clinical trials
Patients having hematuria
Patients with acute urine retention which needs surgical intervention
Patients currently using any other form of medicle therapy for benign prostate hyperplasia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out how Pashanbhedadi Ghanvati reduces the prostate size and post void residual volume |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish the better medicinal alternative in the management of Vaatashthila
To find out effects of Pashanbhedadi Ghanvati on the other symptoms of Vaatashthila |
45 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
"This Study Is Randomized Open Labelled Controlled Clinical Trial Of Efficacy Of Pashanbhedadi Ghanvati In The Management Of Vaatashthila With Special Reference To Benign Prostate Hyperplasia For 45 days And Follow Up And Assesment on 15th, 30th, 45th Day. This study is conducted as a compulsary part of PG course at single centre. The primary outcome is to find out Pashanbhedadi Ghanvati reduces the size of prostate and post void residual volume. |