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

StatusNot Yet Recruiting
PhasePhase 3
Started2025-09-01
View on ClinicalTrials.gov ↗

Amendment history

2025-08-14
minor
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2026-04-05→2027-05-31
Completion date2026-04-05→2027-12-31
Start date2025-02-01→2025-09-01
Study sites1→19
InterventionsExtremely-low dose Susu Xiao'er Zhike Granules (Drug), High dose Susu Xiao'er Zhike Granules (Drug)→Extremely-low dose Susu Xiao'er Zhike Granules (Drug), Susu Xiao'er Zhike Granules (Drug)
Eligibility criteria+39 characters
[...] 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 differentiat [...]
Secondary endpointsdetails revised at 1 of 9 entries
Study title-52 characters
Phase III Clinical Study on Efficacy y and SafetyTrial of Susu Zhike Granules forin Treating Acute Cough Due to Common ColdChildren With Cold-cough Syndrome infor ChildrenAcute Cough Treatment
2025-01-12
minor
Original filing
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.
Trial Details
NCT Number NCT06773117
Lead Sponsor Tasly Pharmaceutical Group Co., Ltd
Conditions Cough
Enrollment 360 participants
Start Date 2025-09-01
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-19