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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068662
Enrollment
Unknown
Registered
2023-02-27
Start date
2022-11-15
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postinfectious cough

Interventions

Experimental group:15 g of active Zihua Wenfei Zhisou Granule three times daily (15 g/bag)
Control group:15 g of Zihua Wenfei Zhisou Granule-matched placebo three times daily (15 g/bag)

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.When signing the informed consent form, the age is between 18 and 65 years old (including 18 and 65 years old) 2.Diagnosis of postinfectious cough; 3. Wind-cold invading lungs syndrome in TCM Zheng; 4. Baseline cough visual analogue scale of 60 mm or more; 5. Cough duration of 3- 6 weeks; 6.Voluntarily provide written and informed consent.

Exclusion criteria

Exclusion criteria: 1.Cough caused by cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough or any other concomitant conditions; 2.Patients with severe pulmonary diseases such as lung cancer, lung tuberculosis, or lung fibrosis; 3.After inhaling bronchodilator, patients with FEV1/FVC= 32 ppb or Bronchial provocation test positive (for FeNO and Bronchial provocation test, if the center cannot detect it, it can be detected in other qualified tertiary hospitals); 7.Combined with serious cardio-cerebrovascular diseases, malignant tumors, diseases of blood and hematopoietic system, gastrointestinal diseases or other serious or progressive diseases of the system; Or those who are unable to cooperate or unwilling to cooperate due to severe mental illness, severe cognitive impairment, etc; 8.Liver and kidney dysfunction: ALT or AST >2 times the upper limit of normal reference value; And/or serum creatinine >1.5 times the upper limit of normal reference value, or eGFR 10.0*109/L, and/or neutrophil granulocyte > 80%; 10.Patients with temperature of 37.3 degree or above; 11.Patients taking similar medications in the last one week; 12.Have a long history of alcohol or drug abuse; 13.Pregnancy or potential pregnancy or lactation; 14.Allergic constitution or known to be allergic to any component in tested drug; 15.Patients having participated or participating in another trial in last 3 month; 16.Patients unsuitable for clinical trials judged by researchers.

Design outcomes

Primary

MeasureTime frame
Cough relief rate;

Secondary

MeasureTime frame
Complete remission rate of cough;Time to cough relief;Complete remission time of cough;Change from baseline in Cough Evaluation Test (CET) value;Change from baseline in VAS value;Change from baseline in TCM syndrome score;Leicester Cough Questionnaire (LCQ);

Countries

China

Contacts

Public ContactBing Mao, Hongli Jiang
maobing@medmail.com.cn18980601724, 18980606651

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026