NCT06773117

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

Efficacy/Safety of Susu Xiao'er Zhike Granules for Children's Cold-Induced Cough (Wind-Cold Syndrome): Multicenter, Randomized, Double-Blind, Low-Dose Controlled Phase III Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan Cao,which relieving cold and cough, resolving phlegm in traditional Chinese medicine theory. This prescription was used for a long time in clinical for treatingacute cough caused by common cold as an herb formula. To standardize the quality and make it easier to take, The investigators reproduced it into a patent medicine and design this trial for evaluating it. The phase II clinical study of Susu Xiaoer Zhike Granules was carried out in the past, and the results showed that the use of Susu Xiaoer Zhike granules (containing 20.25g of raw drug) in the high dose group could significantly improve the clinical recovery rate (P\<0.05) and shorten the clinical recovery time (P\<0.05) in children aged 6 to 14 years (\< 14 years) caused by common cold (wind-cold cough). And good security. Based on the effectiveness and safety results of the phase II clinical study, this study intends to select the high-dose group of the phase II clinical study (containing 20.25g of raw drug) as the experimental group of the phase III clinical study, and the extremely-low dose group of the phase II clinical study as the control group. To conduct confirmatory clinical studies on cough (wind-cold cough) caused by common cold in children aged 6 to 13 years (6 years ≤ age \< 14 years).

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2025-01-14
• Last updated: 2025-08-19

Locations

19 sites across 1 country: China