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

ConditionCough
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-13
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Susu Xiao'er Zhike Granules
  • Extremely-low dose Susu Xiao'er Zhike Granules

Treatment groups

360 Participants
are divided into 2 treatment groups

Locations

19
Anhui Provincial Children's Hospital HefeiAnhui, China
Jiangjin District Central Hospital of Chongqing ChongqingChongqing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine GuangzhouGuangdong, China
Zunyi First People's Hospital ZunyiGuizhou, China

Sponsors and collaborators

Tasly Pharmaceutical Group Co., Ltd

Lead sponsor