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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag (7g granule per bag,contains 1.01 g crude herbs), twice a day for five days
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Jiangjin District Central Hospital of Chongqing
Cough disappearance rate
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).
Time frame: 5 days
Cough symptom score
Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.
Time frame: Baseline, 1, 2, 3, 4, and 5 days
VAS score of cough symptoms
Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.
Time frame: Baseline, 1, 2, 3, 4, and 5 days
Time to disappearance of cough
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).
Time frame: 5 days
Onset time of cough
Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment
Time frame: 5 days
Disease cure rate
Cold symptoms were recorded and evaluated at baseline and after 5 days of treatment.
Time frame: 5 days
PAC-QoL scale score
Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
Effective rate of TCM syndrome
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Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
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Zhengzhou First People's Hospital
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Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
The rate of disappearance of individual symptoms
Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
Incidence OF COMPLICATIONS
Post-treatment records were recorded and end-of-treatment evaluations were performed.
Time frame: 5 days