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Clinical Trials in China / NCT06773117
Starting soon Phase 3

Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment

NCT06773117 · tracked via the Priya Life Science China tracker
Sponsor
Tasly Pharmaceutical Group Co., Ltd
Phase
Phase 3
Started
2025-09-01
Last updated
2025-08-19

Condition(s) studied

Cough

Investigational drug(s) / intervention(s)

Susu Xiao'er Zhike GranulesExtremely-low dose Susu Xiao'er Zhike Granules

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)

Trial sites (19)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06773117 on ClinicalTrials.gov ↗ ← All trials in China