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Recruiting Phase 1, Phase 2 NCT06949904

The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia

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Trial Parameters

Condition Pneumonia Childhood
Sponsor Mian Muhammad Hassan Ahmed
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 60
Sex ALL
Min Age 1 Month
Max Age 12 Years
Start Date 2025-05
Completion 2025-12
Interventions
Melatonin

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Brief Summary

The goal of this study is to compare the mean length of hospital stay between children with pneumonia receiving melatonin as an adjuvant therapy and those receiving standard of care alone. The hypothesis is that combining oral melatonin with standard treatment can reduce the length of hospital stay as compared to standard of care alone. The control group will receive standard treatment (antibiotic) while the intervention group will receive standard treatment plus melatonin for 14 days.

Eligibility Criteria

Inclusion Criteria: * 1 month to 12 years * Both genders * Patient diagnosed as having pneumonia or severe pneumonia according to WHO definition Exclusion Criteria: * Hospitalized within 14 days prior to the study * Known TB exposure * Active varicella or herpes simplex infection * Allergy to the study medication * Currently taking melatonin * Any non pneumonia acute medical illness which requires antibiotic treatment as per local standard of care * Galactose intolerance, the lapp-lactase deficiency or glucose-galactose malabsorption * Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

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