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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Susu Xiao'er Zhike Granules 1 bag |
|
| control group | Other | Extremely-low dose Susu Xiao'er Zhike Granules 1 bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Susu Xiao'er Zhike Granules | Drug | Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cough symptom score | Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment. | Baseline, 1, 2, 3, 4, and 5 days |
| VAS score of cough symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinmin Li | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Children's Hospital | Hefei | Anhui | China |
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| Extremely-low dose Susu Xiao'er Zhike Granules | Drug | 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 |
|
Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.
| 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). | 5 days |
| Onset time of cough | Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment | 5 days |
| Disease cure rate | Cold symptoms were recorded and evaluated at baseline and after 5 days of treatment. | 5 days |
| PAC-QoL scale score | Baseline and 5 days of treatment were recorded and evaluated. | 5 days |
| Effective rate of TCM syndrome | Baseline and 5 days of treatment were recorded and evaluated. | 5 days |
| The rate of disappearance of individual symptoms | Baseline and 5 days of treatment were recorded and evaluated. | 5 days |
| Incidence OF COMPLICATIONS | Post-treatment records were recorded and end-of-treatment evaluations were performed. | 5 days |
| Jiangjin District Central Hospital of Chongqing | Chongqing | Chongqing Municipality | China |
|
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | China |
|
| Zunyi First People's Hospital | Zunyi | Guizhou | China |
|
| Xingtai People's Hospital | Xingtai | Hebei | China |
|
| The First Affiliated Hospital of Henan University | Kaifeng | Henan | China |
|
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | China |
|
| Sanmenxia Central Hospital | Sanmenxia | Henan | China |
|
| Zhengzhou First People's Hospital | Zhengzhou | Henan | China |
|
| Sinopharm Dongfeng General Hospital | Shiyan | Hubei | China |
|
| The First Affiliated Hospital of Hunan University of Chinese Medicine | Changshang | Huna | China |
|
| Huai'an First People's Hospital | Huai'an | Jiangsu | China |
|
| Wuxi Eighth People's Hospital | Wuxi | Jiangsu | China |
|
| The Affiliated Hospital of Yanbian University (Yanbian Hospital) | Yanji | Jilin | China |
|
| The Second Affiliated Hospital of Shaanxi University of Chinese Medicine | Xianyang | Shaanxi | China |
|
| Changzhi People's Hospital | Changzhi | Shanxi | China |
|
| The Affiliated Hospital of Chengdu University of Chinese Medicine | Chengdu | Sichuan | China |
|
| The First Teaching Hospital of Tianjin University of TCM | Tianjin | Tianjin Municipality | 300381 | China |
|
| Tianjin Children's Hospital | Tianjin | Tianjin Municipality | China |
|
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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