| CTRI Number |
CTRI/2021/03/031771 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
06/03/2021 |
| 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
|
To study Bilwamooladi Kwath in burning micturation |
|
Scientific Title of Study
|
“Randomized Control Clinical Trial Of Bilwamooladi Kwath In Pittaj
Mootrakrichhra “ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta
Dhanwantari Hospital
Kayachikitsa Department
Sangli
MAHARASHTRA
416301
India |
| Phone |
08149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Smita Vitthal Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta
Dhanwantari Hospital
Kayachikitsa Department
Sangli
MAHARASHTRA
416301
India |
| Phone |
08149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VdPrasad Bhalchandra Dixit |
| Designation |
PG SCHOLAR |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta
Kayachikitsa Department
Sangli
MAHARASHTRA
416301
India |
| Phone |
9763358887 |
| Fax |
|
| Email |
vdprasaddixit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| 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 |
| Prasad Bhalchandra Dixit |
Dhanwantari Hospital Ashta |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta
Kayachikitsa Department
Sangli
MAHARASHTRA |
9763358887
vdprasaddixit@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:N390||Urinary tract infection, site notspecified. Ayurveda Condition: PITTAJ MOOTRAKRICHHRA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilwamooladi Kwath |
Bilwamooladi Kwath orally 20ml BD For 14 days |
| Comparator Agent |
Dhatryadi Kwath |
Dhatryadi Kwath orally 20ml BD for 14 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
laboratory Investigation having pus cells in urine(>5). |
|
| ExclusionCriteria |
| Details |
1) Patient suffering from other urinary obstruction, Neurological Disease causing urinary retention, presence of foreign bodies such as calculi, indwelling catheters or other drainage devices.
2) Renal failure,Renal transplant patient.
3) UTI in pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the Efficacy of Bilwamooladi Kwath And Dhatryadi Kwath in Pittaj Mootrakrichhhra
Efficacy will be checked by Urine Examination of patient. |
24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Characteristic of Bilwamooladi Kwath And Dhatryadi Kwath in Pittaj Mootrakrichhhra |
18 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
11/03/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mootrakrichhra is the disease of Mootravaha Srotas characterised by difficulty in Micturation . In Samhita Gadnigraha Acharya Sodhal gives the formulation of bilwamooladi kwath.for clinical trial Dhatryadi Kwath which is proven drug mention in bhaishajya ratnawali is taken. |