NCT02362906

Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Liaoning University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.

Detailed description

The block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Xiyanping injection	ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
DRUG	wind-heat formula granules	children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
DRUG	phlegm-heat formula granules	children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
DRUG	Fu-xiong San	external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily
DRUG	second generation cephalosporin
DRUG	Erythromycin	ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
DRUG	Azithromycin	ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• First posted: 2015-02-13
• Last updated: 2015-02-13

Locations

10 sites across 1 country: China