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Effect of Uraimathirai in Increasing children Immunity

Phase 2
Completed
Conditions
Health Condition 1: J069- Acute upper respiratory infection,unspecified
Registration Number
CTRI/2017/06/008723
Lead Sponsor
CENTRAL COUNCIL FOR RESEARCH IN SIDDHA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Children of either gender aged 6 MONTHS to 6 Years with a history of recurrent URTIs and presenting with URTI at hospital treatment.

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The definition used for recurrent URTIs was three or more such episodes during the last 12 months.

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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

Exclusion Criteria

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
NameTimeMethod
Reduction in Recurrence of Resp Infections <br/ ><br> <br/ ><br>Clinical Improvement <br/ ><br> <br/ ><br>No Antibiotic treatment <br/ ><br> <br/ ><br>Increase in Anti bodies IgA/IgG <br/ ><br> Decrease in Phagocytosis <br/ ><br>Timepoint: 6 months <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Safety of trial drugTimepoint: 6 months
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