Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): a multicenter, randomized, double-blind, placebo-controlled trial

Zihua Wenfei granules for postinfectious cough (wind-cold invading lungs syndrome): a multicenter, randomized, double-blind, placebo-controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022078

Enrollment

Unknown

Registered

2019-03-23

Start date

2019-03-25

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

postinfectious cough

Interventions

1:15 g of active ZHWFG three times daily (10 g/bag +5 g/bag)

2:10 g of active ZHWFG plus 5 g of ZHWFG-matched placebo three times daily

3:15 g of ZHWFG-matched placebo (10 g/bag +5 g/bag) three times daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of postinfectious cough; 2. Wind-cold invading lungs syndrome in TCM Zheng; 3. Cough duration of 3- 6 weeks; 4. Baseline cough visual analogue scale of 60 mm or more; 5. Aged 18 to 65 years; 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. Use of an angiotensin-converting-enzyme inhibitor; 4. Current smokers or recent ex-smokers quitting smoking less than 3 months ago; 5. FeNO>30 ppb or Bronchial provocation test positive; 6. Mental patients or legal disability, or patient with severe underlying cerebral, hematological, hepatic or renal disorders or other diseases significantly affecting the survival and prognosis, such as AIDS or cancer; 7. ALT or AST>1.5 times of normal upper limit, urine protein>+, serum creatine abnormality; 8. White blood cell count10×10^9/L, and/or neutrophil granulocyte>80%; 9. Patients with temperature of 37.3? or above; 10. Patients taking similar medications in the last one month; 11. Pregnancy or potential pregnancy or lactation; 12. Allergic constitution or known to be allergic to any component in tested drug; 13. Patients having participated or participating in another trial in last 3 month; 14. Patients unsuitable for clinical trials judged by researchers.

Design outcomes

Primary

Measure	Time frame
Cough resolution rate;Cough relief rate;	—

Secondary

Measure	Time frame
Time to cough resolution;Time to cough relief;Change from baseline in cough symptom score;Change from baseline in VAS value;Change from baseline in TCM syndrome score;Change of CQLQ from baseline to post-treatment;	—

Countries

China

Contacts

Public ContactBing Mao

maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026