A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection

• Status: Unknown status
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients with acute upper respiratory infection: A double blind, double dummy, randomized, controlled trial. It is a post-marketing clinical study to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection.

Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating patients with acute upper respiratory infection.

Study design：multi-center double-blind, double-dummy, randomized, controlled trial

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Beijing Hospital of Traditional Chinese Medicine; Changchun University of Chinese Medicine; First Affiliated Hospital of Heilongjiang Chinese Medicine University; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Guangdong Provincial Hospital of Traditional Chinese Medicine; Liaoning University of Traditional Chinese Medicine; Shandong University of Traditional Chinese Medicine

Criteria

Inclusion Criteria

• Patients diagnosed as acute upper respiratory infection.

• Patients with acute upper respiratory infection diagnosed as Traditional Chinese Medicine(TCM) syndrome wind-heat attacking the Lung (type of heat pathogen invading the defensive Qi of the lung).

• Acute upper respiratory infection onset time is less than 36 hours.

• Patients aged 18 to 70 years old.

• Patients agreed to participate this study and sign the informed consent.

Exclusion Criteria:

• Patients diagnosed with suppurative tonsillitis (third degree), and chest X-ray imaging showed lung inflammation;

• White blood cell counts more than 12 E9, neutrophils more than 80%, ALT, AST, BUN, Cr more than 2 times of the normal upper limit;

• Patients with temperature lower than 37.5 degree centigrade, and without sore throat;

• Patients with temperature higher than 38.5 degree centigrade;

• Patients already receiving antibiotics or other similar drug treatment;

• Patients associated with other severe primary lung diseases, such as lung cancer, tuberculosis, pneumonia and other infectious diseases;

• Patients complicated with cardiovascular and cerebrovascular diseases, severe primary diseases of hematopoietic system, mental illness;

• Pregnant or lactating women;

• Patients with immunodeficiency resulted from organ transplantation, HIV / AIDS, or long-term use of immunosuppressive agents;

• Patients with drug allergy;

• Patients participating in other clinical trials, which influence outcome evaluation of the research.