clinical trial on Children With Respiratory Tract Infections
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2021/04/032990
- Lead Sponsor
- Jagdale industries pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 125
i.Volunteer aged between 7-14 years (both inclusive)
ii.Proven to be healthy and parents willing to give written consent to participate
i.Children having cerebral palsy physical disability and children requiring IEP with epilepsy will be excluded from the study
ii.Patients with preexisting severe systemic disease necessitating long term medication.
iii.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
iv.Any onco neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments.
v.Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Less number (% change) of clinical deteriorations (defined as a significant change in clinical status /hospitalization). <br/ ><br>2.Safety aspects in the Groups receiving Mulmina Mango along with antibiotic(s) <br/ ><br>3.Significant change in the clinical symptoms in Groups receiving antibiotics along with Mulmina Mango. <br/ ><br>4.Significant change in the biomarkers in Groups receiving antibiotics along with Mulmina Mango. <br/ ><br>Timepoint: Day 0, 7 and 28
- Secondary Outcome Measures
Name Time Method General health and Adverse eventsTimepoint: Day 0 to Day 28