Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT05764668
Eligibility Criteria:
Inclusion Criteria:
* When signing the informed consent form, the age is between 18 and 65 years old (including 18 and 65 years old)；
* Diagnosis of postinfectious cough;
* Wind-cold invading lungs syndrome in TCM Zheng;
* Baseline cough visual analogue scale of 60 mm or more;
* Cough duration of 3- 6 weeks;
* Voluntarily provide written and informed consent.
Exclusion Criteria:
* Cough caused by cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough or any other concomitant conditions;
* Patients with severe pulmonary diseases such as lung cancer, lung tuberculosis, or lung fibrosis;
* After inhaling bronchodilator, patients with FEV1/FVC\<70% were excluded;
* Subjects who have taken angiotensin-converting-enzyme inhibitor (ACEI) in the past month;
* Current smokers or recent ex-smokers quitting smoking less than 3 months ago;
* FeNO ≥ 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);
* 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;
* 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\< 60 mL/min/1.73m2;
* White blood cell count \< 3.0×109/L or \> 10.0×109/L, and/or neutrophil granulocyte \> 80%;
* Patients with temperature of 37.3℃ or above;
* Patients taking similar medications in the last one week;
* Have a long history of alcohol or drug abuse;
* Pregnancy or potential pregnancy or lactation;
* Allergic constitution or known to be allergic to any component in tested drug;
* Patients having participated or participating in another trial in last 3 month;
* Patients unsuitable for clinical trials judged by researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05764668
Study Brief:
Protocol Section:
NCT05764668