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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cough Condition Improvement Assessment
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1: 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.
干预措施: Azka Nasal and Throat for Children (Dietary Supplement)
Arm 2: 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.
干预措施: Prospan cough Syrup (Drug)
结局指标
主要结局
Cough Condition Improvement Assessment
时间窗: 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
时间窗: 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.
次要结局
- Adverse Events Monitoring(Throughout the 15-Day Study Period)