Homoeopathic treatment of respiratory tract infection in children

Phase 2/3

Recruiting

• Conditions: Acute upper respiratory infection,unspecified,

• Registration Number: CTRI/2020/10/028743
• Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary

Respiratory tract diseases are common human ailments with which people, especially children, are brought to health facilities. Upper respiratory tract infection (URTI) mainly includes rhinitis, nasopharyngitis, acute sinusitis, tonsillitis, otitis media, acute mastoiditis, laryngotracheobronchitis (croup), acute epiglottitis and diphtheria. In developing countries, on an average, every child has 6.8 to 8.8 episodes of URTI per year, accounting for 30 to 50% of the total paediatric outpatient visits and 20-30% of the paediatric admissions. Though homoeopathic medicines showed its positive result in URTI, but rigorous clinical trials has scarcity. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from URTI will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical-looking placebo (control; n=30). We aim to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Wisconsin Upper Respiratory Symptom Survey (WURSS-21) scores, Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire scores and URI symptom severity scale (URI-SSS) scores will be used as the primary and econdary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-10-29
• Study Start: 2020-10-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children of age group 1-11 years and of either sex 2.
• Clinical signs and symptoms of an URTI with a duration of ≥ 24 hours with or without fever ≥37.5áµ’C 3.
• At least 1 of 3 types of URTI symptoms – nasal (plugged nose, runny nose, sneezing), pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), and cough (ordinary cough without suspicion of acute lower respiratory tract disease) 4.
• At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active.
• Literate guardians or attendants capable of understanding and filling the questionnaire and providing written informed consent.

Exclusion Criteria

• Severe or complicated course of URTI 2.
• Signs of acute LRTI 3.
• COVID-19 positive cases as diagnosed by RT-PCR method 4.
• Current symptoms mainly induced by other acute ENT diseases 5.
• Daily use of antibiotics, steroids and cytotoxic agents 6.
• Diagnosed cases of unstable developmental, mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure 7.
• Immune-compromised state, and 8.
• Already undergoing homoeopathic or other modes of treatment for URTI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wisconsin Upper Respiratory Symptom Survey (WURSS-21) scores	At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days

Secondary Outcome Measures

Name	Time	Method
Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire scores	At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days
URI symptom severity scale (URI-SSS) scores	At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days

Trial Locations

Locations (1)

D. N. De Homoeopathic Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

D. N. De Homoeopathic Medical College and Hospital

🇮🇳Kolkata, WEST BENGAL, India

Agnik Karmakar

Principal investigator

8981794866

agnikkarmakarag@gmail.com