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

Not Applicable

Completed

• Conditions: Cough Severity; Cough Frequency; Cough Duration; Phlegm Accumulation (Nasal and Throat Mucus)
• Interventions: Dietary Supplement: Azka Nasal and Throat for Children; Drug: Prospan cough Syrup

• Registration Number: NCT06761339
• Lead Sponsor: Haiphong University of Medicine and Pharmacy

Brief Summary

This is a randomized, open-label, single-center clinical trial evaluating the efficacy and safety of Azka Nasal and Throat for Children compared to the control drug Prospan Cough Syrup in children aged 4-6 years diagnosed with acute nasopharyngitis. Participants will be randomly assigned in a 1:1 ratio to receive either Azka Nasal and Throat or Prospan Cough Syrup for 7 days. The study aims to assess improvements in cough and phlegm conditions, as well as monitor adverse events associated with the interventions. Data will be collected over a 15-day period, including screening, treatment, and follow-up phases.

Detailed Description

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 dose, three times daily, 30 minutes before meals, for 7 days.

The study spans 15 days for each participant, consisting of three phases:

Screening Phase (1 day): Eligibility determined based on inclusion and exclusion criteria.

Treatment Phase (7 days): Daily administration of the assigned intervention. Follow-Up Phase (7 days): Monitoring of post-treatment outcomes. Primary outcomes include changes in cough and phlegm conditions assessed on Days 4 and 8, using the PCC scale, cough frequency, and duration of each episode, as well as the assessment of nasal and throat mucus. Secondary outcomes include the evaluation of adverse events for both interventions.

Data will be analyzed using SPSS Statistics 23.0 software to determine efficacy and safety. Descriptive statistics, t-tests, and Mann-Whitney tests will be applied based on data distribution. A significance level of p \< 0.05 will be used.

This study seeks to provide valuable insights into the effectiveness of Azka Nasal and Throat for Children in improving respiratory symptoms and its safety profile compared to an established control drug.

Study Timeline

• Study First Submitted: 2024-12-22
• Study Start: 2024-12-23
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Primary Completion: 2025-02-27
• Status Verified: 2025-04
• Study Completion: 2025-04-28
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Azka Nasal and Throat for Children	Azka Nasal and Throat for Children	This arm includes 12 patients who receive the health supplement Azka Nasal and Throat for Children. Participants take the product orally, 7.5 ml per dose, three times a day, 30 minutes before meals, for 7 days.
Arm 2: Prospan Cough Syrup	Prospan cough Syrup	This arm includes 12 patients who receive the control drug Prospan Cough Syrup. Participants take the product orally, 2.5 ml per dose, three times a day, 30 minutes before meals, for 7 days.

Primary Outcome Measures

Name	Time	Method
Cough Condition Improvement Assessment	Day 4 and Day 8	Description: Assessment of changes in cough severity, frequency, and duration using the Pediatric Cough Questionnaire (PCQ). The PCQ uses a scale ranging from 0 (Not at all) to 25 (Extremely severe). Higher scores indicate worse outcomes.
Phlegm Severity Improvement Assessment	Day 4 and Day 8	Description: Assessment of phlegm condition using three categories: No Phlegm: Absence of nasal and throat mucus. Improved/Reduced: Reduction in phlegm quantity or severity. Completely Resolved: Complete resolution of phlegm symptoms. The assessment is based on clinical evaluation at baseline (Day 0), Day 4, and Day 8.

Secondary Outcome Measures

Name	Time	Method
Adverse Events Monitoring	Throughout the 15-Day Study Period	Monitoring and recording of adverse events associated with Azka Nasal and Throat for Children and Prospan Cough Syrup throughout the study period.

Trial Locations

Locations (1)

Center for Clinical Trial and Bioequivalence Study; 🇻🇳 Hai Phong, Vietnam