| CTRI Number |
CTRI/2017/06/008723 [Registered on: 01/06/2017] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Uraimathirai in Increasing children Immunity |
|
Scientific Title of Study
|
Evaluation of Clinical efficacy of Uraimathirai as Immunomodulator |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRPSATHIYARAJESWARAN |
| Designation |
ASST DIRECTOR |
| Affiliation |
SIDDHA CENTRAL RESEARCH INSTITUTE |
| Address |
SIDDHA CENTRAL RESEARCH INSTITUTE
ANNA HOSPITAL CAMPUS
ARUMBAKKAM
CHENNAI
Thiruvallur
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddha2k6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRPSATHIYARAJESWARAN |
| Designation |
ASST DIRECTOR |
| Affiliation |
SIDDHA CENTRAL RESEARCH INSTITUTE |
| Address |
SIDDHA CENTRAL RESEARCH INSTITUTE
ANNA HOSPITAL CAMPUS
ARUMBAKKAM
CHENNAI
Thiruvallur
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddha2k6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRPSATHIYARAJESWARAN |
| Designation |
ASST DIRECTOR |
| Affiliation |
SIDDHA CENTRAL RESEARCH INSTITUTE |
| Address |
SIDDHA CENTRAL RESEARCH INSTITUTE
ANNA HOSPITAL CAMPUS
ARUMBAKKAM
CHENNAI
Thiruvallur
TAMIL NADU
600106
India |
| Phone |
04426214809 |
| Fax |
04426214809 |
| Email |
siddha2k6@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN SIDDHA MINISTRY OF AYUSH SIDDHA CENTRAL RESEARCH INSTITUTE ANNA HOSPITAL CAMPUS CHENNAI
|
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN SIDDHA |
| Address |
SIDDHA CENTRAL RESEARCH INSTITUTE
ANNA HOSPITAL CAMPUS ARUMBAKKAM CHENNAI |
| Type of Sponsor |
Research institution |
|
|
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 P SATHIYARAJESWARAN |
Siddha central research Institute |
Anna Hospital Campus Arumbakkam
Chennai
Thiruvallur
TAMIL NADU |
09443579540
siddha2k6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCRI ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
THALEESATHI CHOORANAM |
1 GRAM TWICE DAILY FOR SIX MONTHS |
| Intervention |
URAI MATHIRAI |
50 MG DAILY UPTO SIX MONTHS |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children of either gender aged 6 MONTHS to 6 Years with a history of recurrent URTIs and presenting with URTI at hospital treatment.
Â
The definition used for recurrent URTIs was three or more such episodes during the last 12 months.
Â
The current episode required for study eligibility was
Defined by the presence of at least two of the following
Rhinitis
Pharyngitis
cough
hoarseness,
Temperature More than 38.5°C,
Prescription of an antibiotic for a URTI, occurring after an asymptomatic Period of at least 1 week without antibiotics
|
|
| ExclusionCriteria |
| Details |
occurrence of otitis media and/or sinusitis and/or
infection of the lower respiratory tract (ie, bronchitis, pneumonia)and/or proven group A streptococcal angina at the enrollment
Further main exclusion criteria were allergic asthma,
significant systemic disease (eg, hepatic and/or
renal disease, malignancy), immune system disorders, suspected
Malabsorption, major surgical procedure within 3 months of commencement of the study
recent immunosuppressive or immunostimulant therapy, or corticosteroids.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Recurrence of Resp Infections
Clinical Improvement
No Antibiotic treatment
Increase in Anti bodies IgA/IgG
Decrease in Phagocytosis
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Urai mathirai is a Siddha formulation found in Hospital pharmacopoeia of Govt siddha medical college Palayamkottai and in use for the past 3 decades. It is observed in Pediatric general practice that Children nursed with Uraimathirai are free from repeated respiratory infection and Uraimathirai is claimed to have Immuno modulating properties. However this Claim is left untested and this PhD study will help to establish the efficacy of the drug comparing with Traditional Siddha formulation Thaleesathy Chooranam 1 gm Bid and Uraimathirai 50 mg daily for continuously for Six months.Before entering into Clinical study Preclinical studies are being carried out to establish the safety and standard of the Drug. |