Trials / Completed
CompletedNCT04457011
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Randomized, Double-blind, Dose Exploration,Multi-center Phase II Clinical Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Tasly Pharmaceutical Group Co., Ltd · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children.
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, we reproduced it into a patent medicine and design this trial for evaluating it.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | High dose Susu Xiao'er Zhike Granules 1 bag | High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days |
| DRUG | Middle dose Susu Xiao'er Zhike Granules 1 bag | Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.12 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days |
| DRUG | Extremely-low dose Susu Xiao'er Zhike Granules 1 bag | Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 1.01 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days |
Timeline
- Start date
- 2020-09-19
- Primary completion
- 2022-02-24
- Completion
- 2022-02-24
- First posted
- 2020-07-07
- Last updated
- 2024-09-05
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04457011. Inclusion in this directory is not an endorsement.