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.
Patients in treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day). Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. After that, there will be a follow-up 14 days after drug withdrawal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
14 daily- doses of Zihua Wenfei Zhisou Granule，one bag at a time (15 g/bag), three times/day
14 daily- doses of placebo，one bag at a time (15 g/bag), three times/day
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGCough relief rate
Cough relief refers to a 50% or more reduction in cough VAS score
Time frame: day 14
Complete remission rate of cough
Complete remission of cough refers to cough VAS score\<17 mm
Time frame: day 14
Time to cough relief
Time to cough relief
Time frame: day 14
Complete remission time of cough
Complete remission time of cough
Time frame: day 14
Change from baseline in Cough Evaluation Test (CET) value
Change from baseline in Cough Evaluation Test (CET) value
Time frame: day 0、day 7、day 14
Change from baseline in visual analogue scale (VAS) value
The visual analogue scale (VAS) is a 100 mm scale, with a minimum value of 0 mm and a maximum value of 100 mm. 0 mm means that the cough is not troubled at all, and 100 mm means that the cough is the most troubled.
Time frame: day 0、day 7、day 14
Change from baseline in TCM syndrome score
Change from baseline in TCM syndrome score
Time frame: day 0、day 7、day 14
Change from baseline in Leicester Cough Questionnaire (LCQ) score
The LCQ comprises 19 items and takes 5 to 10 minutes to complete. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. It contains 19 items which are divided over 3 domains: physical (8 items), psychological (7 items) and social (4 items), with a 7-point Likert response scale.
Time frame: day 0、day 14、day 28
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