Efficacy/Safety of Susu Xiao'er Zhike Granules for Children's Cold-Induced Cough (Wind-Cold Syndrome): Multicenter, Randomized, Double-Blind, Low-Dose Controlled Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 19
- 主要终点
- Cough disappearance rate
研究概览
简要总结
To confirm the effect of Susu Xiaoer Zhike granules in treating cough caused by common cold (wind-cold cough Syndromes) in children aged 6~13 years, shortening the course of disease and improving symptoms.
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, The investigators reproduced it into a patent medicine and design this trial for evaluating it.
The phase II clinical study of Susu Xiaoer Zhike Granules was carried out in the past, and the results showed that the use of Susu Xiaoer Zhike granules (containing 20.25g of raw drug) in the high dose group could significantly improve the clinical recovery rate (P<0.05) and shorten the clinical recovery time (P<0.05) in children aged 6 to 14 years (< 14 years) caused by common cold (wind-cold cough). And good security. Based on the effectiveness and safety results of the phase II clinical study, this study intends to select the high-dose group of the phase II clinical study (containing 20.25g of raw drug) as the experimental group of the phase III clinical study, and the extremely-low dose group of the phase II clinical study as the control group. To conduct confirmatory clinical studies on cough (wind-cold cough) caused by common cold in children aged 6 to 13 years (6 years ≤ age < 14 years).
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It met the diagnostic criteria for common cold, and the severity VAS score of day or night cough was ≥40 mm ，the cough symptom score was ≥2 points;
- •Conforming to the standard of wind-cold cough differentiation;
- •Age 6-13 years old (6 years old ≤ age < 14 years old);
- •Duration of cough ≤48 hours;
- •Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
- •The informed consent process should be in accordance with the regulations, and the legal guardian or the subject child (≥8 years old) should sign the informed consent.
排除标准
- •accompanied by pharyngeal swelling pain, heat image is obvious;
- •White blood cell count, neutrophils absolute value, C-reactive protein, all exceeded the upper limit of 1.2 times the reference value, and the researchers considered the bacterial infection;
- •there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);
- •Patients with acute bronchitis and pneumonia cured less than 8 weeks;
- •People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
- •Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
- •Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
- •Those who had used Chinese and Western drugs and therapies that had influence on the effectiveness evaluation of the experimental drugs within 24 h before enrollment;
- •Allergic to known components of the investigational drug;
- •Those who participated in other clinical trials and took investigational drugs within the past one month;
- •Those who were not considered suitable for inclusion by the researchers.
研究组 & 干预措施
experimental group
Susu Xiao'er Zhike Granules 1 bag
干预措施: Susu Xiao'er Zhike Granules (Drug)
control group
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
干预措施: Extremely-low dose Susu Xiao'er Zhike Granules (Drug)
结局指标
主要结局
Cough disappearance rate
时间窗: 5 days
Cough symptom scores were recorded at baseline and daily after treatment and evaluated at the end of treatment (Patients whose cough did not disappear were followed up for 24 hours).
次要结局
- Cough symptom score(Baseline, 1, 2, 3, 4, and 5 days)
- VAS score of cough symptoms(Baseline, 1, 2, 3, 4, and 5 days)
- Time to disappearance of cough(5 days)
- Onset time of cough(5 days)
- Disease cure rate(5 days)
- PAC-QoL scale score(5 days)
- Effective rate of TCM syndrome(5 days)
- Incidence OF COMPLICATIONS(5 days)
- The rate of disappearance of individual symptoms(5 days)