A randomized, double-blind, placebo-controlled clinical trial of Shufeng Zhike Mixture in the treatment of post-infectious cough (fengxie loves the lung syndrome)

Phase 3

• Conditions: cough after the infection

• Registration Number: ITMCTR2100005046
• Lead Sponsor: West China Hospital of Sichuan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of Western medicine for post-infection cough;
2. In line with the diagnostic criteria of Chinese medicine for cough, wind and pathogenic love of the lung syndrome;
3. Cough severity score >=40;
4. Cough duration 3-8 weeks;
5. Age 18-65 years old;
6. Informed consent and signed the informed consent form.

Exclusion Criteria

1. Patients with cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough, chronic bronchitis and other causes of cough;
2. Patients with severe pulmonary diseases (such as chronic obstructive pulmonary disease, lung cancer, tuberculosis);
3. Patients who have taken angiotensin-converting enzyme inhibitors within the past 2 months;
4. Patients with abnormal behavior or mental illness;
5. Patients who smoke or quit smoking for less than three months;
6. Combined with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney and hematopoietic system, or serious diseases affecting their survival, such as tumor or AIDS; or mentally or legally disabled patients; 7. ALT>1.5 times normal upper limit of reference value, and/or serum creatinine > upper limit of normal reference value;
8. White blood cells <3.0x10^9/L or >10.0x10^9/L, and/or neutrophil classification>80%;
9. Patients who have taken drugs similar to those of the experimental drug in the past 1 month;
10. Women who are pregnant or planning to become pregnant, women who are breastfeeding; those with allergic constitution or known ingredients of the drug; those who have participated in clinical trials of other drugs in the past 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cough disappearance rate;

Secondary Outcome Measures

Name	Time	Method
cough recurrence rate;cough disappearance time;cough relief rate;changes in cough symptoms point;