| CTRI Number |
CTRI/2025/01/079040 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Gokshur Ksheerapaka in pittaja mutrakrichchra (lower urinary tract infection) |
|
Scientific Title of Study
|
Randomized Control Clinical Trail Of Gokshur Ksheerapaka In Pittaja Mutrakrichchra With Special Reference To Uncomplicated Lower Urinary Tract Infection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tehreen Mohammed Tarique |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD No-1 kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Maharashtra
416301
India
OPD No-1 kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Maharashtra
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600218837 |
| Fax |
|
| Email |
tehreentariq@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parag Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Maharashtra
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Maharashtra
416301
India
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta
Tal Walwa
Dist Sangli
Maharashtra
416301
India |
|
|
Primary Sponsor
|
| Name |
Dr Tehreen Mohammed Tarique |
| Address |
OPD No 1 kayachikitsa OPD Dhanvantari Ayurved Hospital Ashta |
| Type of Sponsor |
Other [] |
|
|
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 Tehreen Mohammed Tarique |
Hon Shri Annasaheb Dange Ayurved Medical College and Dhanavantri Ayurved Hospital Ashta |
OPD No-1 Kayachikitsa OPD Ground Floor Dhanvantri Ayurved Hospital Ashta
Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA |
8600210037
tehreentariq@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta 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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshur , Reference: Bhavprakash, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari , Reference: sahastra yog sanghraha, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1]Patients presenting with complain of
sadaha , saruja , muhurmuhu and peetamutrapravrutti
2]Age group between 18yrs to 60 yrs
3] Patients Irrespective of Gender , Caste , Religion , Socio economic status |
|
| ExclusionCriteria |
| Details |
1.]Urinary tract infection associated with renal calculi which need surgical intervention
2.]Surgical conditions like Bph, Phimosis and paraphimosis , renal transplant
3.]Traumatic causes
4.]Ckd , AKI
6.]Neurological diseases causing urine retention
7.]Indwelling catherter or other drainage device |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gokshur ksheerapaka is effective in pittaja mutrakrichchra,urine r&m will be assessed before and after study |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shatavari ksheerapaka is effective in pittaja mutrakrichchra,urine r&m will be assessed before & after the study |
14 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In todays time there is progressive increasing prevalence of UTI in women and men aswell.Clinical and theorotical symptomology of pittaja mutrakrichchra co relates well with UTI. Currently increased scenario of antibiotic resistance and side effects on renal system has been seen so there is need to find new option for treatment. In ayurvedic text gokshur is agrya dravya in treating mutrakrichchra it is also bastishodhak, krimighna, and madhur ras and sheet virya is effective in pacifying pittaja dosha.ksheerapaka kalpana is also easy to make and palatable.Here I will study the effect of gokshur ksheerapaka in management of pittaja mutrakrichchra which will reduce pus cells counts. So here i will give gokshur ksheerapaka for 14 days and check pus cells before and after treatment. |