Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treat… (NCT06773117) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment
China360 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range6 Years – 13 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
✓. 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
✕. 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;
✕. People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
✕. Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
✕. 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;