Susu Xiao'er Zhike Granules: 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: 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
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
13 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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;
2. Conforming to the standard of wind-cold cough differentiation;
3. Age 6-13 years old (6 years old ≤ age \< 14 years old);
4. Duration of cough ≤48 hours;
5. Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
6. 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.
Exclusion Criteria:
1. accompanied by pharyngeal swelling pain, heat image is obvious;
2. 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;
3. there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);
4. Patients with acute bronchitis and pneumonia cured less than 8 weeks;
5. People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
6. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
7. Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
8. 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;
9. Allergic to known components of the investigational drug;
10. Those who participated in other clinical trials and took investigational drugs within the past one month;
11. Those who were not considered suitable for inclusion by the researchers.
Primary outcome measure(s)
Cough disappearance rate — 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).
Trial sites (19)
Facility
City
Region
Status
Anhui Provincial Children's Hospital
Hefei
Anhui
Jiangjin District Central Hospital of Chongqing
Chongqing
Chongqing Municipality
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou
Guangdong
Zunyi First People's Hospital
Zunyi
Guizhou
Xingtai People's Hospital
Xingtai
Hebei
The First Affiliated Hospital of Henan University
Kaifeng
Henan
The First Affiliated Hospital of Nanyang Medical College
Nanyang
Henan
Sanmenxia Central Hospital
Sanmenxia
Henan
Zhengzhou First People's Hospital
Zhengzhou
Henan
Sinopharm Dongfeng General Hospital
Shiyan
Hubei
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changshang
Huna
Huai'an First People's Hospital
Huai'an
Jiangsu
Wuxi Eighth People's Hospital
Wuxi
Jiangsu
The Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanji
Jilin
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang
Shaanxi
Changzhi People's Hospital
Changzhi
Shanxi
The Affiliated Hospital of Chengdu University of Chinese Medicine
Chengdu
Sichuan
The First Teaching Hospital of Tianjin University of TCM
Tianjin
Tianjin Municipality
Tianjin Children's Hospital
Tianjin
Tianjin Municipality
More Tasly Pharmaceutical Group Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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