Confirmatory clinical trial on the efficacy and safety of Zhizhike Granule in the treatment of acute tracheal bronchitis (wind-heat lung disease)

Phase 1

Recruiting

• Conditions: Acute trachea-bronchitis (pneumonitis syndrome)

• Registration Number: ITMCTR2100004508
• Lead Sponsor: Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients meeting the diagnostic criteria of acute tracheobronchitis;
2. Patients who meet the diagnostic criteria of wind heat invading lung syndrome of traditional Chinese medicine;
3. Patients with vas >= 60mm;
4. Patients aged between 18 and 65, male and female;
5. Patients whose course of disease is within 7 days;
6. Patients who voluntarily received the drug and signed the informed consent.

Exclusion Criteria

The patients with any of the following conditions could not be included in this trial:
1. Patients with chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess and chest X-ray showing pulmonary inflammatory lesions and other respiratory diseases;
2. Patients with serious primary diseases of cardiovascular, cerebrovascular, pulmonary, renal and hematopoietic systems; diabetic patients; patients with abnormal ECG and clinical significance;
3. Patients who smoke;
4. Patients using ACEI drugs;
5. Patients with body temperature >= 38.5 degrees C;
6. Patients with liver function test value (ALT, AST) exceeding 1.5 times of the upper limit of normal value; SCR higher than the upper limit of normal reference value, or / and BUN higher than 1.5 times of the upper limit of normal value, or / and UA higher than 1.5 times of the upper limit of normal value; WBC less than 3.0 x 10^9 / L or greater than 10.0 x 10^9 / L, and / or neutrophil percentage > 80%; fasting blood glucose greater than or equal to 6.9 mmol / L; and;
7. Patients who have used other drugs to treat the disease after onset (including antibiotics, expectorants, antitussive drugs, systemic or inhaled sex hormones, inhaled bronchodilators, Xinliang jiebiao, Qingre Jiedu and other related traditional Chinese Medicine);
8. Pregnant, lactating women and subjects with pregnancy plans in the last 3 months;
9. Subjects with allergic constitution or allergic to known components of the drug;
10. Patients with serious diseases (such as tumor, etc.) and psychosis that affect their survival;
11. Patients who have participated in clinical trials of other drugs within one month and are currently participating in clinical trials of other drugs;
12. The researchers believe that there are patients who are not suitable for inclusion.

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
Changes in cough VAS score;Duration of remission and disappearance of cough;Cough remission rate;Changes of BSS total score and single symptom score;TCM syndrome integral changes;