Efficacy and safety of Xingbei Zhike granules in treatment of post-infectious cough (Wind-heat Invading the Lung Syndrome): A multicenter, randomized, double-blind, placebo-controlled trial

Efficacy and safety of Xingbei Zhike granules in treatment of postinfectious cough (Wind-heat Invading the Lung Syndrome): A multicenter, randomized, double-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000004063

Enrollment

Unknown

Registered

2020-11-20

Start date

2020-11-23

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

post-infectious cough

Interventions

control group:Xingbei Zhike granules simulant

experimental group:Xingbei Zhike granules

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients meet the diagnosis standard of post-infectious cough; (2) The TCM classification is Wind-heat Invading the Lung Syndrome; (3) Scores of cough >=3 (during day and night); (4) Aged 18 to 65 years old (including 18 and 65 years old); (5) Patients have been fully informed and voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with gastroesophageal reflux disease, cough variant asthma, eosinophilia bronchitis, bronchiectasis, bronchial asthma or chronic obstructive pulmonary disease; (2) White blood cell count >12*10^9/L, and neutrophil greater than ULN; (3) Patients with cardio-cerebrovascular, liver, kidney, or hematological disease, or other serious primary diseases. ALT or AST> 1.5 ULN, serum creatinine > 1.5 ULN; (4) Suspected or proven history of alcohol or drug abuse, or a person with a mental illness; (5) Pregnant or lactating women, or women who have birth plan; (6) Allergic constitution or be allergy to the drug composition used in the trial; (7) patients who is participating or participated in last 3 months in other drug clinical trial.

Design outcomes

Primary

Measure	Time frame
Area under the curve of visual analogue scale (VAS) for cough symptoms;	—

Secondary

Measure	Time frame
The total amount and times of alleviating drug use;Scores of cough symptom;Scores of Leicester Cough Quality of Life Questionnaire(LCQ);Duration for cough to disappea;The TCM scores;Disappearance rate of individual symptoms;Disappearance rate of cough symptoms;	—

Countries

Chian

Contacts

Public ContactLin Lin

Guangdong Provincial Hospital of Traditional Chinese Medicine

drlinlin620@163.com+86 13903002015

Outcome results

None listed

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