| 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
|
|
|
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
|
|
|
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. |