Effect of Uraimathirai in Increasing children Immunity
- Conditions
- Acute upper respiratory infection,unspecified,
- Registration Number
- CTRI/2017/06/008723
- Lead Sponsor
- CENTRAL COUNCIL FOR RESEARCH IN SIDDHA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 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.
-  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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Recurrence of Resp Infections 6 months Clinical Improvement 6 months No Antibiotic treatment 6 months Increase in Anti bodies IgA/IgG 6 months Decrease in Phagocytosis 6 months
- Secondary Outcome Measures
Name Time Method Safety of trial drug 6 months
Trial Locations
- Locations (1)
Siddha central research Institute
🇮🇳Thiruvallur, TAMIL NADU, India
Siddha central research Institute🇮🇳Thiruvallur, TAMIL NADU, IndiaDR P SATHIYARAJESWARANPrincipal investigator09443579540siddha2k6@gmail.com