Clinical Trial Evaluate the Cough-relieving and Expectorant Effects of the Health Supplement AZKA Nasal and Throat for Children in Outpatient-treated Pharyngitis

Launched by HAIPHONG UNIVERSITY OF MEDICINE AND PHARMACY · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial aims to compare the efficacy and safety of Azka Nasal and Throat for Children, a registered health supplement, with Prospan Cough Syrup, a commonly used control drug. The study targets children aged 4-6 years diagnosed with acute nasopharyngitis, presenting symptoms such as cough, nasal mucus, and throat phlegm.

Participants will be randomly assigned in a 1:1 ratio to one of two arms:

Azka Nasal and Throat for Children: Administered orally at 7.5 ml per dose, three times daily, 30 minutes before meals, for 7 days.

Prospan Cough Syrup: Administered orally at 2.5 ml per...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 4-6 years. Parents or guardians agree to participate and are capable of attending study visits and assisting their children with procedures outlined in the study protocol. Parents or guardians must also agree to sign the Informed Consent Form (ICF).
• • A confirmed diagnosis of acute nasopharyngitis at the initial visit. Presence of symptoms such as cough, nasal mucus, and throat phlegm at the initial visit.
• Exclusion Criteria:
• • Complicated pharyngitis. History of malignancies in any organ system or unstable conditions that may pose risks to the participant during the study.
• After screening, participants will be randomly assigned in a 1:1 ratio to one of the following interventions:
• • Azka Nasal and Throat for Children. Prospan Cough Syrup (control drug).
• Additional Exclusions:
• • Planned hospitalization during the study period. Participation in a clinical trial within the past 14 days. Investigator's assessment that the participant is unsuitable for the study due to an inability to comply with the study procedures, restrictions, or requirements.