The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Randomized, Double-blind, Dose Exploration,Multi-center Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- Time to Resolution of cough/ resolution rate
研究概览
简要总结
This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children.
详细描述
Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan Cao,which relieving cold and cough, resolving phlegm in traditional Chinese medicine theory. This prescription was used for a long time in clinical for treatingacute cough caused by common cold as an herb formula. To standardize the quality and make it easier to take, we reproduced it into a patent medicine and design this trial for evaluating it.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as common cold standard, and VAS score of daytime or night-time cough >= 40mm;
- •Diagnosed as wind cold cough syndrome;
- •Aged 6-14 ( < 14) years;
- •The course of cough is <= 48 hours;
- •The maximum temperature is <= 38 degree C within 24 hours before visit;
- •The informed consent process complies with the requirement,and the legal representative and the child (>= 8 years old) sign the informed consent form.
排除标准
- •Accompanied by sore throat, obvious fever;
- •The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
- •With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
- •Acute bronchitis, pneumonia have been cured less than 8 weeks;
- •With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
- •Patients with severe malnutrition;
- •Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders;
- •Allergic to the experimental drugs;
- •Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment;
- •The investigator considers it inappropriate to participate in this clinical trial.
研究组 & 干预措施
High dose group
High dose Susu Xiao'er Zhike Granules, 1 bag, bid
干预措施: High dose Susu Xiao'er Zhike Granules 1 bag (Drug)
Middle dose group
Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid
干预措施: Middle dose Susu Xiao'er Zhike Granules 1 bag (Drug)
Extremely-low dose group
Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid
干预措施: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag (Drug)
结局指标
主要结局
Time to Resolution of cough/ resolution rate
时间窗: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
Clinical cure is assessed based on visual analogue scale(VAS) score of cough severity, and defined as both VAS scores of day-time and night-time cough reduce to 17mm or less, and last for 24 hours. Day-time refers to 6AM-10PM, night-time refers to 10PM-6AM. The cough VAS is a 100mm line segment, its length represents cough severity (both cough frequent and tense should be considered). 0mm=no cough, 100mm=worst cough, seriously impacting life quality such as playing, going to school, sleeping.18 Day-time and night-time VAS are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours. Children will be trained to use this assessment tool after randomized, and will recorded it by themselves via dairy with the assistance of their parents.
次要结局
- Time to relief of cough(The median time of relief of cough during Day 2-Day 6.)
- Area Under the cough VAS- Time Curve(Baseline(Day1),Day 2-Day 6 post-treatment)
- Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score(Baseline(Day1),the last 24 hours post-treatment)
- Overall improvement of cough(The last 24 hours post-treatment)
- Disappearance rate of Traditional Chinese Medicine(TCM) symptom(Baseline(Day1),the last 24 hours post-treatment)
- Curative effect of Traditional Chinese Medicine(TCM) syndrome(Baseline(Day1),the last 24 hours post-treatment)