CTRI Number |
CTRI/2023/09/057245 [Registered on: 05/09/2023] Trial Registered Prospectively |
Last Modified On: |
01/09/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
Gandhaga Mezhugu for treating Urinaray infection |
Scientific Title of Study
|
An Open Clinical Trial To Evaluate The Effectiveness Of Gandhaga Mezhugu In The Management of Neerkiricharam (Urinary Tract Infection) - A Pilot Study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DKayalvizhi |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
Op No.11/12, Department of Gunapadam, Ayothidoss Pandithar Hospital, Tambaram Sanitorium, Chennai.
Chennai TAMIL NADU 600047 India |
Phone |
9952993996 |
Fax |
|
Email |
drdkayalvizhisiddha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SSudha Reavthy |
Designation |
Assistant Professor |
Affiliation |
National Institute of Siddha |
Address |
Op No.11/12, Department of Gunapadam Ayothidoss Pandithar Hospital Tambaram Sanitorium Chennai
Chennai TAMIL NADU 600047 India |
Phone |
9884222449 |
Fax |
|
Email |
dr.sudharevathy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DKayalvizhi |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
Op No. 11/12, Department of Gunapadam, Ayothidoss Pandithar Hospital, Tambaram Sanitorium, Chennai
Chennai TAMIL NADU 600047 India |
Phone |
9952993996 |
Fax |
|
Email |
drdkayalvizhisiddha@gmail.com |
|
Source of Monetary or Material Support
|
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tamabaram Sanitorium
Chennai 600047 |
|
Primary Sponsor
|
Name |
National Institute of Siddha |
Address |
Ayothidoss Pandithar Hospital,
Tambaram Sanitorium, Chennai 600047 |
Type of Sponsor |
Research institution and hospital |
|
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 |
DrDKayalvizhi |
National Institute of Siddha |
OP No.11/12
Department of Gunapadam
National Institute of Siddha
Ayothidoss Pandithar Hospital
Tambaram Sanitorium
Chennai-Trichy Highway
Chennai -600 047
Chennai TAMIL NADU |
9952993996
drdkayalvizhisiddha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instituitional Ethics Committee- National Institute of Siddha, Chennai-600 047 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Gandhaga Mezhugu |
Gandhaga mezhugu 400mg/bd/milk, afterfood is given for 14 days. |
Comparator Agent |
Not Applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Presenting with the clinical signs and symptoms of Uncomplicated Urinary Tract infection
2.Patients with positive urine culture for bacterial growth
3.Patients willing to take urine routine, urine culture and radiological investigation
|
|
ExclusionCriteria |
Details |
1.Patients presenting with signs and symptoms of complicated UTI
(those arising in a setting of catheterization, instrumentation, urologic
anatomic or functional abnormalities, stones, obstruction,
immunosuppression, cancer, renal or hepatic disease)
2.Pregnant and lactating women
3.Known cases of Genitourinary tuberculosis,Diabetes Mellitus, Sexually transmitted diseases like HIV & Syphilis
4.Patient not willing to undergo urine routine and urine culture |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Urine culture test negative for bacterial growth. |
14days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessment of absence or decreased severity of
clinical signs-symptoms after completion of the
course of drug |
14 days |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
11/09/2023 |
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="0" 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
|
This is an Open labelled, Non randomized, Single
centric clinical trial to evaluate the effectiveness of Gandhaga
Mezhugu in the management of Neerkiricharam (Urinary
Tract infections). Urinary tract infections (UTIs) are common infections that
affects any part of the urinary system, which includes the kidneys, bladder,
ureters, and urethra. UTIs are typically caused by bacteria, with Escherichia
coli (E. coli) being the most common culprit . Every year, around 150 million
UTIs occur worldwide, leading to about $6 billion in healthcare spending. The
usual treatment includes using antibiotics carefully.
However, the growing issue of becoming
resistant to antibiotics is causing concern. This resistance can result in
longer and more severe infections, increased healthcare costs, and a greater
risk of complications. As antibiotic resistance continues to grow, researchers
are exploring alternative treatment options to address UTIs effectively.
Traditional herbal and mineral-based medicines have gained attention as
potential alternatives to antibiotics. These traditional remedies, derived from
plants, minerals, or other natural sources, have been used in various cultures
for centuries to treat infections and promote overall health.
Gandhaga Mezhugu,
a herbo-mineral composite, has exhibited antibacterial properties against
prevalent pathogens responsible for urinary tract infections in preclinical
evaluations. This clinical investigation endeavors to systematically ascertain
the efficacy of Gandhaga Mezhugu, an established therapeutic
approach for multiple infection conditions. The study will be conducted in OP
No. 11/12, Department of Gunapadam, Ayothidoss Pandithar Hospital,
National Institute of Siddha, Chenna. Patients will be screened and recruited
to the study based on the inclusion criteria. The sample size is 10 patients
and the study period is 6 months. The outcome is assessed based on the urine
culture and decrease/absence of the clinical signs and symptoms.
|