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Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome): a Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial
Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute cough has a 3\~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.The drug in this study is for post-infection cough in subacute cough. After long-term clinical practice, six traditional Chinese medicines, including Aster, Lonicera japonica, Shegan, dried ginger, mango seed and Schizonepeta tenuifolia, were selected to form Zihua Wenfei Zhisou Decoction. This product has the effect of relieving wind, relieving cough, warming the lung and resolving phlegm. It can be used for the cough syndrome caused by Wind-cold invading lungs syndrome. The aim is to evaluate the efficacy and safety of Zihua Wenfei Zhisou Granule in the treatment of postinfection cough (wind-cold lung syndrome) with placebo as a control.
Details
| Lead sponsor | DoCare Pharmaceutial Technology Co.,Ltd |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 480 |
| Start date | 2022-11-15 |
| Completion | 2024-08 |
Conditions
- Cough
Interventions
- Zihua Wenfei Zhisou Granule
- Placebo
Primary outcomes
- Cough relief rate — day 14
Cough relief refers to a 50% or more reduction in cough VAS score
Countries
China