The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia
ConditionPneumonia Childhood
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-12
SponsorMian Muhammad Hassan Ahmed
About this trial
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
This trial does not accept healthy volunteersQualifiers
1 month to 12 years
Both genders
Patient diagnosed as having pneumonia or severe pneumonia according to WHO definition
Disqualifiers
Hospitalized within 14 days prior to the study
Known TB exposure
Active varicella or herpes simplex infection
Allergy to the study medication
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin
Drug1 mg/dose in infants and 2.5 to 3mg/dose in children three times a day for 14 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard TreatmentNo intervention 0 interventions
Group B: Adjuvant TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay
The primary outcome is the length of hospital stay, measured in days, from admission to discharge. The mean and standard deviation of hospital stay will be calculated for both groups (melatonin and non-melatonin) and compared using an independent sample t-test.
Time frame
14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mian Muhammad Hassan Ahmed
Lead sponsor
College of Physicians and Surgeons Pakistan
Sponsor institution
Source ClinicalTrials.gov