| CTRI Number |
CTRI/2021/11/038101 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To Study The Effect Of Gokshura Churna In Urinary Tract Infection (Pittaja Mutrakriksha) wsr To Urine Culture |
|
Scientific Title of Study
|
Upashayatmak Study Of Gokshura Churna In Urinary Tract Infection (Pittaja Mutrakriksha) wsr To Urine Culture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rani Jatav |
| Designation |
P. G. Scholar |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College, Datoda, Indore
Indore
MADHYA PRADESH
456010
India |
| Phone |
7509903122 |
| Fax |
|
| Email |
dr.rania02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sipra Sasmal |
| Designation |
Head Of Department |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College, Datoda, Indore
Indore
MADHYA PRADESH
456010
India |
| Phone |
9630993620 |
| Fax |
|
| Email |
drsasmal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sipra Sasmal |
| Designation |
Head Of Department |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Shubhdeep Ayurved Medical College, Datoda, Indore
Indore
MADHYA PRADESH
456010
India |
| Phone |
9630993620 |
| Fax |
|
| Email |
drsasmal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep Ayurved Medical College |
|
|
Primary Sponsor
|
| Name |
Shubhdeep Ayurved Medical College Indore |
| Address |
Shubhdeep Ayurved Medical College, Datoda, Indore |
| 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 |
| Rani Jatav |
Shubhdeep Ayurved Medical college |
department of rognidan evum vikriti vigyan
Shubhdeep Ayurved Medical college and hospital, vill. Datoda, khandwa road, indore
Indore
MADHYA PRADESH |
7509903122
dr.rania02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Shubhdeep Ayurved Medical college |
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: Pittaja Mutrakriksha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshura, Reference: Charak Sutra 25/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Showing puss cells in urine
Diagnosed case of UTI
Second Trimester on wards |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 60 years
Major systemic illness like IHD, CKD, DM, HTN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in classical sign and symptoms of pittaja mutrakriksha |
Gokshura churna fro 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change clinical parameters |
total study period 12 months and treatment period weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
i am select this topic for study because of UTI is very common disease and further it is cause of CKD like disease Clinical study of gukshura churna for 30 days in pittaja mutrakriksha (Urinary Tract Infection). Total 30 patients will be enrolled in present study. |