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