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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033981
Enrollment
Unknown
Registered
2020-06-20
Start date
2018-10-16
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

Acute exacerbation of chronic bronchitis

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The improvement of cough before and after treatment;

Secondary

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

Countries

Pakistan

Contacts

Public ContactShang Gao

Hunan Anbang Pharmaceutical Co., Ltd.

75128317@qq.com+86 13873151989

Outcome results

None listed

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