The randomized double-blind double-simulation and Non-inferior effect of positive control clinical trial study on the efficacy and safety of Yinhuang Qingfei Capsule in the treatment of acute exacerbation of chronic simple bronchitis

Phase 4

Completed

• Conditions: Acute exacerbation of chronic bronchitis

• Registration Number: ITMCTR2000003421
• Lead Sponsor: Center for Bioequivalence Studies and Clinical Research (CBSCR),International Center for Chemical and Biological Sciences(ICCBS),University of Karachi

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

Inclusion Criteria

1. Between the ages of 18-65, both male and female; with BMI 18.5-30kg/m2;
2. Satisfy the diagnostic criteria for acute exacerbation of Simple chronic bronchitis;
3. The main symptom score: expectoration quantification score>=2, cough + expectoration >=6;
4. Course of disease <=7 days;
5. The subject has signed the informed consent form.

Exclusion Criteria

1. Through examination and verification, the chronic cough is caused by other diseases: pulmonary tuberculosis, pneumonia, pneumoconiosis, bronchial asthma, bronchiectasis, lung abscess, or caused by irritant gases, allergies, and ACE inhibitors;
2. With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency;
3. Patients with severe primary cardiovascular, cerebrovascular, pulmonary, renal, endocrine and hematological diseases, and mental illness;
Patients with severe infections: WBC >=11.0 G/L, NEU% >=82%;
4. Subjects with a history if alchol or drug abuse,suspected or confirmed;
5. Body temperature exceed 38.5 degree C before signing consent form;
6. Subjects, who take other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit(including beta 2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.);
7. Allergic individuals and those who are known to be allergic to experimental drugs.(Have a clear history of penicillin and cephalosporins allergy.);
8. Pregnant women, lactating women or fertile women who are ready to conceive in 3 months;
9. Subject, who has participated in the past 3 months or is participating in another drug study;
10. The investigator believes that, there is other lesion or condition that reduces possibility of enrollment or makes the enrollment complex, such as changeable work environment, which easily leads to loss of follow-up;
11. Subjects who are not suitable for the clinical trial based on investigators judgment;
12. BMI>30kg/m2.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The improvement of cough before and after treatment;

Secondary Outcome Measures

Name	Time	Method
Total number of white blood cells and classification count;Life quality (LCQ score);Curative index;The onset time of fever reduction and the time of complete fever reduction;X-ray examination for the lungs;