The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- The duration of cold symptoms
研究概览
简要总结
Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).
详细描述
Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL. Treatment for one week. Patients who were recovered within one week can withdrawal at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 Traditional Chinese Medicine syndrome of qi deficiency and wind-heat.
- •Patients aged 1 to 12 years.
- •With course of disease in 48 hours or less.
- •Signed informed consent by a Parent or legal guardians.
排除标准
- •Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia;
- •Patients have a history of hyperpyretic convulsion;
- •Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases;
- •The increased of serum creatinine (Cr), blood urea nitrogen (BUN), alanine aminotransferase (ALT), and urinary protein, urine RBC above "+", which can not use the test illness or possibly combined disease conditions to explain;
- •Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug;
- •According to the doctors' determination,likely to loss to follow up.
研究组 & 干预措施
Fuganlin Oral Liquid
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
Xiaoer Jiebiao Oral Liquid placebo:oral
1~2 years old: 5mL each time and twice a day
3~5 years old: 5mL each time and three times a day
6~14 years old: 10mL each time and twice a day
干预措施: Fuganlin Oral Liquid (Drug)
Xiaoer Jiebiao Oral Liquid
Xiaoer Jiebiao Oral Liquid:oral
1~2 years old: 5mL each time and twice a day
3~5 years old: 5mL each time and three times a day
6~14 years old: 10mL each time and twice a day
Fuganlin Oral Liquid placebo: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: Xiaoer Jiebiao Oral Liquid (Drug)
结局指标
主要结局
The 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 3 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 number normal or low of 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