Cough SeverityAZKANCT06761339
Clinical Trial Evaluate the Cough-relieving and Expectorant Effects of the Health Supplement AZKA Nasal and Throat for Children in Outpatient-treated Pharyngitis
A study testing Azka Nasal and Throat for Children and Prospan cough Syrup in people with Cough Severity and Cough Frequency, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cough Severity, Cough Frequency, Cough Duration
- What is being tested?
- Azka Nasal and Throat for Children and Prospan cough Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Dec 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Center for Clinical Trial and Bioequivalence Study
Haiphong, 180000
About this study
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
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.
Read the 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)
- Being tested
- Azka Nasal and Throat for Children, Prospan cough Syrup
- Keywords
- Azka Nasal and Throat, Cough Relief
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azka Nasal and Throat for ChildrenDietary 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.
Prospan cough SyrupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Prospan cough Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 4 and Day 8
Secondary outcomes (1)
Adverse Events Monitoring
Monitoring and recording of adverse events associated with Azka Nasal and Throat for Children and Prospan Cough Syrup throughout the study period.
Measured: Throughout the 15-Day Study Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start23 Dec 2024
- Primary completion27 Feb 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough SeverityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761339
- Sponsor's protocol ID
- HPMU.CTBE/P0224
- Other IDs
- 01/2024/HD/AV-YDHP
- Acronym
- AZKA
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06761339
- Acronym / sponsor ID
- AZKA / HPMU.CTBE/P0224
- Conditions
- Cough Severity, Cough Frequency, Cough Duration, Phlegm Accumulation (Nasal and Throat Mucus)
- Keywords
- Azka Nasal and Throat, Cough Relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Azka Nasal and Throat for Children | Experimental | Dietary Supplement: Azka Nasal and Throat for ChildrenThis 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 | Active comparator | Drug: Prospan cough SyrupThis 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azka Nasal and Throat for ChildrenAzka 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. | Dietary supplement | Arm 1: Azka Nasal and Throat for Children |
| Prospan cough SyrupThe 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. | Drug | Arm 2: Prospan Cough Syrup |
Primary outcome
Cough Condition Improvement Assessment
Time frame: 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
Time frame: 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.
1 secondary outcome
Adverse Events Monitoring
Time frame: Throughout the 15-Day Study Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azka Nasal and Throat for Children and Prospan cough Syrup in people with Cough Severity and Cough Frequency, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Condition Improvement Assessment (time frame: Day 4 and Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.