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

NCT ID: NCT03675178

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-22
• Study Completion Date: 2019-12-31

Brief Summary

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.

Detailed 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.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

treatment group

Anerning particle +ceftriaxone sodium

Group Type: EXPERIMENTAL

Anerning particle

Intervention Type: DRUG

Anerning particle ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.

control group

Anerning particle placebo+ceftriaxone sodium

Group Type: PLACEBO_COMPARATOR

control group

Intervention Type: DRUG

Anerning particle placebo ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.

Interventions

Anerning particle

Anerning particle ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.

Intervention Type: DRUG

control group

Anerning particle placebo ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.

Intervention Type: DRUG

Other Intervention Names

ceftriaxone sodium; Anerning particle placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Yanming Xie

Deputy director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Central Contacts

Yanming Xie, BA

Role: CONTACT

ktzu2018@163.com

86-13911112416

Lianxin Wang, Doctor

Role: CONTACT

wlxing@126.com

86-13521781839

Other Identifiers

Anerning particle

Identifier Type: -

Identifier Source: org_study_id