Community Acquired Pneumonia Clinical Trial
Official title:
Evaluation of Clinical Value and Safety of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children Based on Real-world Clinical Data
Verified date | October 2019 |
Source | Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In order to verify the clinical value and safety of Xiyanping injection in children with CAP, we intend to carry out this multi-center, large-sample, non-intervention clinical research through more rigorous and scientific design. Considering the current status of clinical research in children in China,research use real-world research methods.
Status | Not yet recruiting |
Enrollment | 9207 |
Est. completion date | March 1, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 14 Years |
Eligibility |
Inclusion criteria: - 2 years old < age = 14 years old children, male or female, diagnosed as community-acquired pneumonia diagnosed and need hospitalization Exclusion criteria: - Acute infectious diseases such as measles, whooping cough, and influenza - Other concomitant diseases or conditions that the investigators believe may interfere with the study, such as severe primary disease with severe heart, liver, kidney, digestive, and hematopoietic systems - Children with severe malnutrition and previous history of immunodeficiency may seriously affect the self-limiting course of the disease - Children with epilepsy and other central nervous system dysfunction - Congenital diseases, mental patients - Those who have used systemic hormones within 2 weeks before enrollment; - Those who have used Qingrejiedu Chinese medicine within 2 weeks before enrollment - The subject is poorly compliant (not according to the doctor's prescription or medical advice) or fails to timely feedback information |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Alleviation of Cough and Lung X-ray | significant efficiency: cough and lung X-ray show obvious improvement of symptoms within 3 days; effective: cough and lung X-ray symptoms improve within 3 to 7 days; invalid: no change or aggravation of lung symptoms after 7 days' treatment. Total effective rate = significant efficiency rate + effective rate | 7 days | |
Primary | Time to Alleviation of Body Temperature | significant efficiency: body temperature return to normal within 3 days; effective: body temperature return to normal within 3 to 7 days; invalid: body temperature can't return to normal after 7 days' treatment. Total effective rate = significant efficiency rate + effective rate | 7 days |
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