| CTRI Number |
CTRI/2023/02/049992 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Of Triphaladya Churna In The Treatment Of Urine Retention In Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Triphaladya Churna In The Management Of Vatashthila (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 |
SHUBHAM SHARMA |
| Designation |
MS SCHOLAR SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 3 SHALYATANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE
SANT TUKARAM NAGAR PIMPRI PUNE 18 MAHARASHTRA 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
6377635801 |
| Fax |
|
| Email |
shubhamsharma05659@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY CHANDRAKANT BABAR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT SHALYATANTRA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO. 3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY CHANDRAKANT BABAR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT SHALYATANTRA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO. 3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 18 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. D.Y. Patil College Of Ayurved and Research Centre, Pimpri, Pune-18.
DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
SHUBHAM SHARMA |
| Address |
OPD NO 3 , DR. D.Y. Patil College Of Ayurved and Research Centre, Pimpri, Pune-18.
DEEMED TO BE UNIVERSITY |
| 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 SHUBHAM SHARMA |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 3 DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE
SANT TUKARAM
NAGAR PIMPRI PUNE 18 411018
MAHARASHTRA
Pune
MAHARASHTRA |
6377635801
shubhamsharma05659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND RECOGNITION COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N394||Other specified urinary incontinence. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladya churna, Reference: Ayurveda, Route: Oral, Dosage Form: Churna/ Powder, Dose: 11.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
A) K/C/O Vatashthila.
B) Patient having any of 3 sign & symptoms of disease like incomplete emptying, frequency, intermittency,urgency,weak stream, straining and nocturia.
C) Male patient, irrespective of socio- economic status. |
|
| ExclusionCriteria |
| Details |
a) Bladder neck stenosis, bladder diverticulum, neurogenic bladder, neoplasm of bladder, urethral stricture.
b) Patients with malignancy of prostate
c) Patient with associated disease like T.B. , Leprosy, Venereal disease ,immuno- compromised.
d) Patient with major complication like uremia , septicemia , shock, renal failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the efficacy of Triphaladya churna in the management of urine retention in Vatashthila (Benign Prostatic Hyperplasia) |
Triphaladya churna oral administration 1 karsha with lukewarm water twice a day for 15 days.
Follow-up will be on 7th and 15th day.
Total duration of study will be 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To provide safe and cost effective treatment
for relieving urine retention in benign prostatic hyperplasia.
2) To observe the adverse effects of Triphaladya churna. |
Follow-ups will be on 7th and 15th day.
Total duration of study will be 15 days. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/03/2023 |
| 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 Yet Recruiting |
| 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 is a Single Arm Clinical Study in which Triphaladya churna with Luke warm water will be carried out on 32 pre- diagnosed patients of Vatashthila ( Benign Prostatic Hyperplasia) for relieving urine retention due to BPH. Follow- ups will be on 7th and 15th day and total duration of the study will be 15 days. The age group taken for the study will be 45 years and upto 80 years. |