Clinical trial NCT06761339: Clinical Trial Evaluate the Cough-relieving and Expectorant Effects of the Health Supplement AZKA Nasal and Throat for Children in Outpatient-treated Pharyngitis
Official title: A Randomized, Open-Label, Single-Center, Controlled Clinical Trial to Evaluate the Cough-Relieving and Expectorant Effects of the Health Supplement AZKA Nasal and Throat for Children With Outpatient-Treated Pharyngitis at Hai Phong University of Medicine and Pharmacy Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough Severity
Cough Frequency
Cough Duration
Phlegm Accumulation (Nasal and Throat Mucus)
Keywords: Azka Nasal and Throat
Cough Relief
Lead sponsor: Haiphong University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial compares Azka Nasal and Throat for Children with the control drug Prospan Cough Syrup. The study duration for each participant is 15 days, which includes a 1-day screening phase, a 7-day treatment phase, and a 7-day follow-up phase after the final dose. Participants take the study products orally, 7.5 ml per dose, three times a day, 30 minutes before meals.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Cough Condition Improvement Assessment
timeFrame: Day 4 and Day 8
measure: Phlegm Severity Improvement Assessment
timeFrame: Day 4 and Day 8
Secondary outcomes:
measure: Adverse Events Monitoring
timeFrame: Throughout the 15-Day Study Period
Other outcomes:
Locations:
city: Hai Phong
country: Vietnam
facility: Center for Clinical Trial and Bioequivalence Study
Study officials:
References: