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

NCT06761339 | Completed DMC

• 2 other identifiers: HPMU.CTBE/P022401/2024/HD/AV-YDHP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Azka Nasal and Throat; Cough Relief

Outcome Measures

Primary Outcomes (2)

• Cough Condition Improvement Assessment

  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.

  Day 4 and Day 8

• Phlegm Severity Improvement Assessment

  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.

  Day 4 and Day 8

Secondary Outcomes (1)

• Adverse Events Monitoring

  Throughout the 15-Day Study Period

Study Arms (2)

Arm 1: Azka Nasal and Throat for Children

EXPERIMENTAL

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.

Dietary Supplement: Azka Nasal and Throat for Children

Arm 2: Prospan Cough Syrup

ACTIVE COMPARATOR

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.

Drug: Prospan cough Syrup

Interventions

Azka Nasal and Throat for Children DIETARY_SUPPLEMENT

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.

Arm 1: Azka Nasal and Throat for Children

Prospan cough Syrup DRUG

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.

Arm 2: Prospan Cough Syrup

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Center for Clinical Trial and Bioequivalence Study

Haiphong, 180000, Vietnam

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 7, 2025
• Study Start: December 23, 2024
• Primary Completion: February 27, 2025
• Study Completion: April 28, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

VN (1)