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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 


 
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