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CTRI Number  CTRI/2024/07/070870 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 17/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Other 
Public Title of Study   A clinical study on Siddha polyherbal formulation Thontha sura Kiyaazham (TSK) in the management of Suram (Fever)in children 
Scientific Title of Study   A scientific approach to evaluate Siddha polyherbal formulation Thontha sura Kiyaazham (TSK) for its Safety and Therapeutic efficacy in experimental animal models and children for the management of clinically diagnosed Suram (Viral Fever)with reference to upper respiratory 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 Uthaya Ganga 
Designation  Ph D Scholar Full Time 
Affiliation  National Institute of Siddha 
Address  ROOM NO 16/17,Department of Kuzhanthai Maruthuvam ,New OPD block,National Institute of Siddha,Tambaram Sanatorium, Chennai 47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9486786300  
Fax    
Email  uthayaganga@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Uthaya Ganga 
Designation  Ph D Scholar Full Time 
Affiliation  National Institute of Siddha 
Address  ROOM NO 16/17,Department of Kuzhanthai Maruthuvam ,New OPD block,National Institute of Siddha,Tambaram Sanatorium, Chennai 47


TAMIL NADU
600047
India 
Phone  9486786300  
Fax    
Email  uthayaganga@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Suresh 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  ROOM NO 16/17,Department of Kuzhanthai Maruthuvam ,New OPD block,National Institute of Siddha,Tambaram Sanatorium, Chennai 47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha 
 
Primary Sponsor  
Name  National institute of Siddha 
Address  Room No 16/17,Department of Kuzhanthai Maruthuvam,New OPD Block,National Institute of Siddha,Chennai 47 
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 R Uthaya Ganga  National Institute of Siddha  Room NO 16/17,Department of Kuzhanthai Maruthuvam,New OPD Block,
Kancheepuram
TAMIL NADU 
9486786300

uthayaganga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Siddha Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B349||Viral infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Thontha Sura Kiyaazham  Thontha Sura Kiyaazham is a poly herbal decoction medicine.It is mentioned in Siddha literature and indicated for Fever. Dose 80 ml Frequency Two times per day Route Per oral Duration 3 days 
 
Inclusion Criteria  
Age From  6.00 Day(s)
Age To  12.00 Day(s)
Gender  Both 
Details  Having oral temperature 99 F-102 F
Children with following three or more symptoms
Pharyngitis, Dry cough, Coryza, Headache, Myalgia, Chills, Malaise, Anorexia 
 
ExclusionCriteria 
Details  Having oral temperature more than 102 F
Children with H/O Convulsion and other chronic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of oral body temperature and clinical improvement in associated symptoms  Baseline body temperature is 98.6 F 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2024 
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)  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  

INTRODUCTION

             Siddha Medicine is  an ancient medical system in the world which is believed to be originated more than many thousands years ago. Siddha medicine classifies disease and disorders into 4448 types and has remedy for more than 64 types of fever. Siddha literature says that fever is the main symptoms for many diseases. The trial drug Thontha Sura Kiyaazham is mentioned in Siddha literature and indicated to treat all types of fever.

MATERIALS AND METHODS

            Children aged between 6 to 12 years of all genders will be included in the trial after signing consent form. Participants reporting at the Kuzhanthai maruthuvam OPD at NIS associated with clinical features of fever, Pharyngitis, Dry Cough, coryza, Headache, Myalgias. Chills, Malaise and anorexia will be chosen for enrolment, based on the inclusion criteria.

EXPECTED OUTCOME

               This study will explore the reduction of the oral temperature from baseline reading with monitoring time duration for fall in temperature and clinical improvement in associated symptoms. The outcome of the treatment should be measured statistically by using appropriate analysis of variance test.

ETHICAL ISSUES

The data collected from the Participants informant will be recorded. The Participants informant will be informed about the diagnosis, treatment and follow- up.

After the consent of the Participants informant (through consent form), Participants will be enrolled in the study.Informed consent will be obtained from the Participants informant explaining in the understandable language to the Participants informant.

Treatment would be provided free of cost. In conditions of treatment failure, adverse reactions, Participants will be given alternative treatment at the National Institute of Siddha with full care. In case of severity condition Participants will be referred to nearby Government Hospital.

 

 

 
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