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A study to evaluate the effectiveness of Kandathri Legium for the treatment of throat infection in children

Phase 2
Not yet recruiting
Conditions
Acute tonsillitis, unspecified,
Registration Number
CTRI/2025/05/086880
Lead Sponsor
National Institute of Siddha
Brief Summary

This study is a prospective open non randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug Kandathri Legium according to body weight adminstering orally twice a day for 24 days in 30 patients during the trial period of 12 months that will be conducted in Ayothidass Pandithar Hospital National Institute of Siddha Tambaram sanatorium chennai The effectiveness of drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Enlarged tonsils with Brodsky scale Grade 2 and above, or Children with positive throat culture [GABHS],or Children having at least three of the symptoms like sore throat,cough, difficulty in swallowing,fever,halitosis,tender swollen cervical lymph nodes.

Exclusion Criteria
  • Children with symptoms of 1.
  • Pneumonia, 2.
  • Oral Candidiasis, 3.
  • Tuberculosis, 4.
  • Peritonsillar abscess.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The efficacy of trial drug will be assessed by reduction in grade of Brodsky Scale and also by improvement in clinical conditionsOn duration of 24 days of drug every seventh day patients will be assessed by Brodsky Scale for tonsillar enlargement and also by improvement in clinical conditions.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ayothidass Pandithar Hospital,National Institute of Siddha

🇮🇳

Kancheepuram, TAMIL NADU, India

Ayothidass Pandithar Hospital,National Institute of Siddha
🇮🇳Kancheepuram, TAMIL NADU, India
Dr V Priyadarshini
Principal investigator
8903404227
priyavenkatesan2797@gmail.com

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