To evaluate effectiveness of Saruva thitha nirgundi thailam for the treatment of throat infection in children.
Phase 2
- Conditions
- Health Condition 1: J039- Acute tonsillitis, unspecified
- Registration Number
- CTRI/2024/06/069475
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children with age group of 5 to 12 years of both sex.
Enlarged tonsils with Brodsky scale Grade 2 and above.
children also having at least three of the following symptoms:
1. Throat pain
2. Cough
3. Difficult to swallow
4. Fever
5. Halitosis
Exclusion Criteria
1. Pneumonia
2. Oral candidiasis
3. Tuberculosis
4. Peritonsillar abscess
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of the trial drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms. <br/ ><br>Enlargement of tonsils will be assessed by Brodsky scale. <br/ ><br>Throat pain will be assessed by VAS score. <br/ ><br>Cough severity will be assessed by VAS score. <br/ ><br>Dysphagia will be assessed based on Bazaz dysphagia scale. <br/ ><br>Halitposis will be assessed based on organoleptic score.Timepoint: Baseline at the time of enrolment - 0th day. <br/ ><br>First follow up - 7th day. <br/ ><br>Second follow up- 14th day. <br/ ><br>End point 28th day.
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Saruva Thitha Nirgundi Thailam's anti-inflammatory effects in acute pharyngo-tonsillitis (J039)?
How does Saruva Thitha Nirgundi Thailam compare to amoxicillin-clavulanate in pediatric acute tonsillitis treatment outcomes?
Which biomarkers correlate with clinical response to Saruva Thitha Nirgundi Thailam in Virana Silethumam (J039) patients?
What are the safety profiles and adverse event management strategies for Saruva Thitha Nirgundi Thailam in pediatric Phase II trials?
Are there synergistic combinations of Saruva Thitha Nirgundi Thailam with other Ayurvedic formulations for throat infections in children?