Skip to content

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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041145
Enrollment
Unknown
Registered
2020-12-19
Start date
2020-12-18
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Acute trachea-bronchitis (pneumonitis syndrome)

Interventions

Sponsors

Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Cough disappearance rate;

Secondary

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

Countries

China

Contacts

Public ContactChen Rilan

Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine

lanlani10000@163.com+86 13877172326

Outcome results

None listed

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