Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: control group; Drug: Anerning particle

Study type: Interventional

Funder types: Other

Identifiers

NCT03675178

Anerning particle

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.

Full description

To evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.In this study, a randomized, double blind, parallel control of placebo, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 216 cases need to be registered at least.The aim population is children who suffering of community-acquired pneumonia from September 2018 to December 2019. These cases will be devided into treatment group（Anerning particle+ Intravenous ceftriaxone sodium）,control group（Anerning particle simulants+ Intravenous ceftriaxone sodium）. Each group will be treated for 10 days hospitalization and if there is adverse drug reaction during treatment, follow-up until the laboratory indicators are normal. The efficacy indicators of this study were mainly from three dimensions: Frequency of antibiotics at the clinical endpoint, Total disease efficiency, Clinical recovery time. The symptom scores changes of each group before and after treatment were observed.

Enrollment: 216 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection;
2. Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome;
3. Children aged 1 to 5 years old;
4. Within 48 hours of onset of CAP;
5. The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.

Exclusion criteria

1. Chest X-ray films showed obvious lung tumors and tuberculosis;
2. Those with acute infectious diseases such as measles, whooping cough, and influenza;
3. Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases;
4. Children with severe malnutrition and immunodeficiency;
5. Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system;
6. Those who meet the CAP (severe) Western diagnostic criteria for children;
7. Clinically diagnosed or clinically considered viral pneumonia, Mycoplasma pneumoniae pneumonia;
8. allergic constitution (allergic to more than 2 types of substances), or allergic to penicillins, cephalosporin antibiotics and Anering granules and their components;
9. Researchers believe that it is not appropriate to join the group.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

Anerning particle +ceftriaxone sodium

Treatment:

Drug: Anerning particle

control group

Placebo Comparator group

Description:

Anerning particle placebo+ceftriaxone sodium

Treatment:

Drug: control group