| CTRI Number |
CTRI/2023/08/056351 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PATALGARUDI FOR THE TRATMENT OF URINARY TRACT INFECTION |
|
Scientific Title of Study
|
A COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATALGARUDI DISPERSABLE TABLET IN THE MANAGEMENT OF LOWER URINARY TRACT INFECTION WITH NITROFURANTOIN |
| 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 AARTI SAINI |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA ROOM NO 106 DEPARTMENT OF SHALYA TANTRA LIMDA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
7015740055 |
| Fax |
|
| Email |
sainiaarti242@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR OM PRAKASH DAVE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA ROOM NO 106 DEPARTMENT OF SHALYA TANTRA LIMDA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9460770626 |
| Fax |
|
| Email |
dr.omprakashdave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR OM PRAKASH DAVE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA ROOM NO 106 DEPARTMENT
OF SHALYA TANTRA LIMDA VADODARA GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9460770626 |
| Fax |
|
| Email |
dr.omprakashdave@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL AYURVED HOSPITAL LIMDA VADODARA |
|
|
Primary Sponsor
|
| Name |
Dr AARTI SAINI |
| Address |
PARUL INSTITUTE OF AYURVEDA ROOM NO 106 DEPARTMENT OF SHALYA TANTRA LIMDA VADODARA GUJARAT |
| 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 AARTI SAINI |
Parul Ayurved Hospital |
PARUL INSTITUTE OF AYURVEDA ROOM NO 106 DEPARTMENT OF SHALYA TANTRA LIMDA VADODARA GUJARAT
Vadodara
GUJARAT |
7015740055
sainiaarti242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: patalgarudi, Reference: raj nighantu 101 103, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | NITROFURANTOIN | NITROFURANTOIN IT IS AN ANTIBIOTIC MEDICATION WHICH IS USED IN TREATMENT OF UNCOMPLICATED LOWER URINARY TRACT INFECTION. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with LUTI
Any of two or more symptoms described in the context of LUTI
Patients irrespective of gender caste and religion
Patient between the age group of 20 70 years
|
|
| ExclusionCriteria |
| Details |
Below the 20 years or above 70 years
Hematuria
Renal failure
Pyelonephritis
Nephrotic syndrome
Septicemia
Chronic systemic illness uncontrolled DM and HTN HIV Malignancy HBsAg TB
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WILL SUBSIDE THE SYMPTOMS OF URINARY TRACT INFECTION |
21 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WILL SUBSIDE THE SYMPTOMS OF LOWER URINARY TRACT INFECTION
Dysuria
Frequency of micturition
Urgency
Fever |
duration of treatment- 14 days
follow up- every 7th day till 28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
20/08/2023 |
| 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 Yet Recruiting |
| 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
|
Aim To evaluate the efficacy of Patalgarudi dispersible tablet in the management of lower urinary tract infection Objectives To observe the efficacy of Patalgarudi dispersible tablet in the management of lower urinary tract infection To evaluate the clinical efficacy of Patalgarudi on urine biochemical parameters To evaluate antibacterial property of Patalgarudi dispersible tablet in vitro study |