| CTRI Number |
CTRI/2021/03/032395 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of ayurved drug preparation gokshura and shatavari tablet in treatment of pittaj mutrakruchra Urinary tract infection |
|
Scientific Title of Study
|
To Study the effect of Gokshura and Shatavari in Pittaj Mutrakruchra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parag Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli |
| Address |
Department of Kayachikitsa opd 1 Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423033159 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kore |
| Designation |
Professor |
| Affiliation |
Parul University Vadodara Gujrat |
| Address |
Parul Institute of Ayurved Limda Vadodara Gujrat
Parul Institute of Ayurved Limda Vadodara Gujrat
Vadodara
GUJARAT
382355
India |
| Phone |
8275174623 |
| Fax |
|
| Email |
naresh.kore86275@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli |
| Address |
Department of Kayachikitsa opd 1 Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423033159 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhanvantari Hospital |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli |
| 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 Parag Deshmukhe |
Dhanvatari Hospital Ashta |
Department of Kayachikitsa opd 1 Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9423033159
pdeshmukhe@yahoo.co.in |
|
|
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:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gokshur shatavari |
Gokshura Shatavari vati
500mg tds
for 7 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical sign and symptoms of pittaj mutrakruchra
Sashool mutrapravrutti
sadah mutrapravrutti
Sarakta mutrapravrutti
Alpa alpa mutrapravrutti
alpa udarshool |
|
| ExclusionCriteria |
| Details |
Patients having phimosis or paraphimosis
Presence of pus cells more than 15 hpf in urine
Presence of RBC more than 10 hpf i urine
Patients suffering from severe systemic disorders
Patients having uncontrolled bowl bladder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Pus cells in urine
Reduction in sign and symptoms of mutrakruchra |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in RBC in Urine |
7 14 21 28 day |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
30/03/2021 |
| 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="3"
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 is clinical trial to study the effect of gokshura and shatavari in pittaj mutrakruchra. especially in patients of urinay tract infection. Total 400 patients will be treated by gokshura and shataavari vati 500mg two tablets three times in day. follow of at 7 14 28 day of treatment. Assessment based on clinical features of pittaj mutrakruchra and pus cells in urine.. |