| CTRI Number |
CTRI/2020/12/029728 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Dhanyaka-gokshuradi ghrita in comparison with Tamsulosin hydrochloride for the treatment of benign enlargement of prostate |
|
Scientific Title of Study
|
randomized controlled clinical study to evaluate the efficacy of dhanyaka-gokshuradi ghrita in comparison with tamsulosin hydrochloride in the management of benign enlargement of prostate |
| Trial Acronym |
management of BEP |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayali Babasaheb Gore |
| Designation |
MS Scholar Shalya Tantra |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
OPD no 3 department of shalya tantra in Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
OPD no 3 department of shalya tantra in Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011336765 |
| Fax |
|
| Email |
goresayali15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Babar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
OPD no 3 department of shalya tantra in Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
OPD no 3 department of shalya tantra Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Babasaheb Gore |
| Designation |
MS Scholar Shalya Tantra |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
OPD no 3 department of shalya tantra in Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
OPD no 3 department of shalya tantra in Dr D Y Patil College Of Ayurveda And Research Centre,Sant Tukaram Nagar Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011336765 |
| Fax |
|
| Email |
goresayali15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurveda And Research Centre Deemed To Be University |
|
|
Primary Sponsor
|
| Name |
Dr Sayali Babasaheb Gore |
| Address |
Dr D Y Patil College Of Ayurveda And Research Centre Sant Nagar Pimpri Pune |
| 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 Sayali Babasaheb Gore |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
Shalya Tantra OPD NO.3,Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune
Pune
MAHARASHTRA |
9011336765
goresayali15@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
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 |
| Intervention |
Dhanyaka-gokshuradi ghrita |
Patient will be selected and treated with Dhanyaka-gokshuradi ghrita drug doses 10 ml once a day (apaan kaal)
Duration of Drug 21 days |
| Comparator Agent |
Tamsulosin hydrochloride 0.4 milligram at night |
Patient will be receive Tablate Tamsulosin hydrochloride 0.4 milligram at night
Duration of drug 21 days
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
•A known diagnosed case of (benign enlargement of prostate) on the basis of clinical and investigative methods.
•Male patient of age group more than 40 -60 yrs. Irrespective of religion and occupation.
•Prostate size below 35 gms
|
|
| ExclusionCriteria |
| Details |
• Acute/chronic retention of urine, stone formation, renal failure.
•Bladder neck stenosis, bladder diverticulum, neurogenic bladder, neoplasm of bladder, urethral stricture.
•CA prostate, Prostitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Benign enlargement of prostate is one of the most common diseases in ageing men and most common cause of lower urinary tract symptoms_
The prevalence of BEP increases after the age of 40 years. Genetics, diet and life style also Contributes for BEP.
2)To evaluate the and establish safer,cost-effective Dhanyaka-gokshuradi ghrita in the management of benign enlargement of prostate-[management of benign enlargement of prostate] |
Duration of treatment 21days total |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dhanyaka-gokshuradi ghrita is effective the management of benign enlargement of prostate-[management of benign enlargement of prostate] |
21 days study with 4 follow up
(0,7,14,21 days)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2020 |
| Date of Study Completion (India) |
22/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give Ayurvedic treatment to diseased patient to improve him condition and we can give him cheap,safe ,side effect free management. The trail will be conducted on 60 patients for follow up 0,7,14,21 days and doses of drugs Dhanyak-gokshuradi ghrita once a day (10 ml- apaan kaal i.e 8 A.m with koshna jala ) And Tamsulosin hydrochloride 0.4 milligram at night with jala.for 21 days |