Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02362906
• Other study ID #: 201307007
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2015
• Last updated: February 12, 2015
• Start date: April 2014

Study information

• Verified date: February 2015
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: Xuefeng Wang, Ph.D
• Phone: 13840208807
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of ChinaChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• children,aged 1 to 14 years old;

• diagnosed as pneumonia according to western medicine diagnostic criteria;

• diagnosed as TCM pneumonia with pneumonia with dyspnea and cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern(tan re bi fei zheng);

• disease progression within 72 hours; those whose guardians understood and assigned the informed consent;

Exclusion Criteria:

• severe pneumonia;

• complicated with other Pulmonary Disorders attack other than pneumonia;

• complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) =1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) >8.2mmol/l, or serum C reactive protein >104umol/l,et al) and blood system (anemia) ,and those with psychopathy;

• allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months;

• those who intend to lost follow-up by practitioners' judgment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
• 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
• 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
• 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
• second generation cephalosporin

• Erythromycin
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
• Azithromycin
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection

Locations

Country	Name	City	State
China	Affiliated Children's Hospital of Capital University of Medical Sciences	Beijing	Beijing
China	Affiliated Hospital of Changchun University of TCM	Changchun	Jilin
China	Affiliated Children's Hospital of Dalian Medical University	Dalian	Liaoning
China	Affiliated hospital of Guangzhou university of Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou Children's Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Shandong University of TCM	Ji'nan	Shandong
China	Affiliated Hospital of Guangxi University of Chinese Medicine	Nanning	Guangxi
China	Affiliated Longhua Hospital of Shanghai University of TCM	Shanghai	Shanghai
China	Affiliated Hospital of Liaoning University of TCM	Shenyang	Liaoning
China	First teaching hospital of Tianjin university of TCM	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Liaoning University of Traditional Chinese Medicine	Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	direct medical cost	medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital	observed during treatment in 7 days	No
Primary	Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)	clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded	every day since receiving treatment,all together 7 days (times)	No
Primary	effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)	days range from treatment is received to the effectiveness is observed, and symptoms disappear	every day since receiving treatment, all together 7 days (times)	No
Secondary	effect in treating fever	temperature, fever frequency,fever lasting time, Ibuprofen Suspension, all to be measured	7 days	No
Secondary	effect in dyspnea releasing	gasp frequency, severity, all to be measured	7 days	No
Secondary	effect in phlegm releasing	phlegm amount,color and nature to be measured	7 days	No
Secondary	effect in cough releasing	cough severity to be measured	7 days	No
Secondary	time from admission to recovery of rales		7 days	No
Secondary	TCM syndrome scores	measure is a composite.	7 days	No
Secondary	effective rate of TCM syndrome scores	total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate	7 days	No
Secondary	check-out time (days counted when the patient checks out)	days counted when the patient checks out	7 days	No
Secondary	pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)	prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up	15 days; 30 days; 90 days	No
Secondary	safety (With adverse events as the calculation basis)	With adverse events as the calculation basis	7 days	Yes