Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Duration of cold symptoms
研究概览
简要总结
Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection
详细描述
Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;
High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;
Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.
Research purpose:
- Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .
- Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.
- Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.
- Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as acute upper respiratory infection.
- •Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.
- •Patients aged 1 to 12 years old.
- •Parents or guardians agreed to participate this study and signed the informed consent.
排除标准
- •Patients whose total numbers of white blood cells around above1.3ULN.
- •Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.
- •Patients allergic to the test drug.
- •Serious cardiovascular, liver,kidney and other primary systemic diseases.
- •Patients should not be included in group according to investigator's evaluation.
研究组 & 干预措施
Low-dose of Fuganlin Oral Liquid
oral
less than 1 years old: 5mL each time and three times a day
1~3 years old: 10mL each time and three times a day
4~6 years old: 10mL each time and four times a day
7~12 years old: 10mL each time and five times a day
干预措施: Low-dose of Fuganlin Oral Liquid (Drug)
High-dose of Fuganlin Oral Liquid
oral
less than 1 years old: 10mL each time and three times a day
1~3 years old: 20mL each time and three times a day
4~6 years old: 20mL each time and four times a day
7~12 years old: 20mL each time and five times a day
干预措施: High-dose of Fuganlin Oral Liquid (Drug)
结局指标
主要结局
Duration of cold symptoms
时间窗: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days
Cold diagnostic criteria： 1. Nasal congestion, runny nose, sneezing, itchy throat, or pain, cough 2. The chills, fever, no sweat or less sweat, headache, limb sour 3. The total numbers of normal or low white blood cells, neutropenia, relative increase in lymphocytes. Cold cure criteria: 1. Fever, aversion to wind individual symptoms disappeared 2. Nasal congestion, runny nose, sore throat, cough individual symptoms disappeared
次要结局
未报告次要终点