NCT06761339

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Haiphong University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cough Severity
• Cough Frequency
• Cough Duration
• Phlegm Accumulation (Nasal and Throat Mucus)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Azka Nasal and Throat for Children	Azka Nasal and Throat for Children is provided as a liquid oral preparation, designed with a pleasant flavor to ensure compliance in pediatric patients. The intervention involves administering 7.5 ml per dose three times daily, taken orally 30 minutes before meals, for a duration of 7 days. The supplement is intended to alleviate symptoms of nasal and throat irritation, reduce phlegm, and improve overall respiratory comfort. Azka Nasal and Throat for Children has been widely used in clinical and community settings, with a favorable safety profile and reported effectiveness in pediatric respiratory care.
DRUG	Prospan cough Syrup	The active comparator, Prospan Cough Syrup is a plant-based herbal medicinal product containing the active ingredient Hedera helix (ivy leaf extract), standardized to ensure consistent pharmacological efficacy. The syrup is formulated as an oral liquid preparation with a pleasant taste suitable for pediatric and adult use. The intervention involves administering 2.5 ml per dose three times daily, taken orally 30 minutes before meals, for a duration of 7 days.

Timeline

• Start date: 2024-12-23
• Primary completion: 2025-02-27
• Completion: 2025-04-28
• First posted: 2025-01-07
• Last updated: 2025-05-06

Locations

1 site across 1 country: Vietnam