FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/058378 [Registered on: 06/10/2023] Trial Registered Prospectively
Last Modified On: 01/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   open clinical evaluation of siddha medicine kaarasooda sathu parpam for the managemen of azhalneerchurukku (Urinary Tract Infection)  
Scientific Title of Study   PHASE II NON RANDOMIZED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE KAARASOODA SATHU PARPAM FOR THE MANAGEMENT OF AZHAL NEERCHURUKKU (URINARY TRACT INFECTION) 
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 R Murugalakshmi 
Designation  PG SCHOLAR 
Affiliation  Government Siddha Medical College, Chennai  
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai. India

Chennai
TAMIL NADU
600106
India 
Phone  9445429052  
Fax    
Email  89murugalakshmi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Anbu 
Designation  HOD and Professor 
Affiliation  GOVERNMENT SIDDHA MEDICAL COLLEGE CHENNAI 
Address  POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 106 Chennai TAMIL NADU 600106 India

Chennai
TAMIL NADU
600106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R Murugalakshmi 
Designation  PG SCHOLAR 
Affiliation  Government Siddha Medical College, Chennai  
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9445429052  
Fax    
Email  89murugalakshmi@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Chennai. 
 
Primary Sponsor  
Name  DR R MURUGALAKSHMI  
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai. 
Type of Sponsor  Other [Government Siddha medical College ] 
 
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 R Murugalakshmi  Arignar anna govt hospital of indian medicine and homeopathy attached with GSMC  Department of PG Pothu maruthuvam, Room no S1, Arumbakkam, Chennai - 600 106. Chennai TAMIL NADU
Chennai
TAMIL NADU 		 9445429052

89murugalakshmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of GSMC, Chennai   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  Kaarasooda sathu parpam   500mg,bd after food with honey,for 15 days. 
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age: 20- 60 years
Sex: Both
Patient having symptoms such as
Frequency of micturition
Burning micturition
Dysuria
Lower abdominal pain
Low backache / supra pubic pain.
Hematuria

Patient with moderate and severe scoring according to UTI symptom assessment scale i.e., ( > 8 ≤ 21)
Patients with Urine culture significant for bacteria or fungus (eg. Escherichia coli, klebsiella, enterococci, proteus mirablis staphylococci etc.....) 
 
ExclusionCriteria 
Details  Pregnancy
H/O Sexually transmitted disease
H/O Malignancy
H/O Diabetesmellitus
Will be excluded clinically or based on the available medical reports. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It is mainly assessed by reduction in clinical signs and symptoms by UTI symptom assessment score and also assessed by urine culture when bacterial/fungal infection becomes negative after treatment  within 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
By comparing the clinical signs and symptoms and the urine culture before and after the treatment 15 days  15 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/10/2023 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [89murugalakshmi@gmail.com].

  6. For how long will this data be available start date provided 02-06-2024 and end date provided 24-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a phase II Non- Randomized open clinical trial to evaluate the safety and efficacy of siddha medicine Kaara sooda sathu parpam for Azhal Neerchurukku (Urinary tract Infection). The Trial drug Kaarasooda sathu parpam will be prepared as mentioned in the book Sikitcha rathna deepam part-2 and will be given as 500 mg twice a day with honey for 15 days.During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. 
Close