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CTRI Number  CTRI/2017/05/008558 [Registered on: 15/05/2017] Trial Registered Retrospectively
Last Modified On: 17/03/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Screening 
Study Design  Single Arm Study 
Public Title of Study   Herbal drug in the treatment of urinary tract infection  
Scientific Title of Study   A pilot study on seenthil sarkarai in the treatment of moothirakiricharam urinary tract infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr T Arulmozhi 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
Chennai
TAMIL NADU
600047
India 
Phone  7418422440  
Fax    
Email  mozhiarul1401@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Visweswaran 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
Chennai
TAMIL NADU
600047
India 
Phone  9962542755  
Fax    
Email  svisu11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Visweswaran 
Designation  Lecturer 
Affiliation  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
National Institute of Siddha Tambaram Sanatorium Chennai TAMIL NADU 600047 India
Chennai
TAMIL NADU
600047
India 
Phone  9962542755  
Fax    
Email  svisu11@gmail.com  
 
Source of Monetary or Material Support  
Dr T Arulmozhi National Institute of Siddha Tambaram Sanatorium Chennai Tamilnadu 600047 India 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai-47 Tamilnadu 
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 
Dr T Arulmozhi  National Institute of Siddha  Out patient ward Room Number II Department of Gunapadam National Institute of Siddha Tambaram Sanatorium Chennai 47
Chennai
TAMIL NADU 		 7418422440

mozhiarul1401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Perons affected with urinary tract infection ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  SEENTHIL SARKARAI  internal medicine 2gm twice a day with warm water,21 days duration,indicated for urinary tract infection,jaundice,hepatomegaly. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  burning micturition
persistent urge to urinate
foul smelling urine
cloudy urine
presence of pus cells above the normal range
positive urine culture test 
 
ExclusionCriteria 
Details  pregnancy
medical renal disease
any other serious systemic illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to reduce the bacterial load in urine  after 21 days from the start of the study 
 
Secondary Outcome  
Outcome  TimePoints 
reduction of clinical signs and symptoms
 		 21 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   18/01/2017 
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)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Urinary tract infection(UTI) is considered to be the most common bacterial infections. Women are significantly more likely to experience UTI than  in men. Nearly 1 in 3 women will have had at least 1 episodes of UTI requiring antimicrobial therapy by the age of 24 years. Almost half of all women will experience 1 UTI during their lifetime. Catheter associated UTI is the most common nosocomial infection, accounting for > 1million cases in hospital and nursing homes. I have choosen seenthil sarkarai , a Siddha formulation which is mentioned in Siddha literature which is indicated for UTI. Objective of this trial is to determine the effectiveness of seenthil sarkarai in the treatment of  urinary tract infection.

 
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