Effectiveness Study of Integrative Treatment for Pediatric 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 PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069665
• Other study ID #: AHLN-TCM-01
• Status: Completed
• Phase: N/A
• First received: December 26, 2013
• Last updated: February 20, 2014
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: n/a
• 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 retrospective case study has been finished at the National clinical research base of traditional Chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. Based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial.

The block randomization is used in this trial. Random numbers are generated by SPSS software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria;

• diagnosed as TCM pneumonia with gasp-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:

• emergency pneumonia;

• complicated with other Pulmonary Disorders attack other than pneumonia;

• complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (ALT, and AST = 1.5 times of normal value ceiling), kidney (BUN > 8.2mmol/L, or serum CR > 104 µmol/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.

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

Other:
• Fuxiong San
external application; 8-10cm wide, 0.3-0.5cm thick; 10mins for patient aged 1 to 3-year old; 15mins for those aged 3 to 5-year old; once daily

Drug:
• Xiyanping injection
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
• Ribavirin Injection
ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
• Xiaoer Qingfei Heji (mixture)
children aged 6 months to 1 year old: 10 ml, orally taken three times daily; children aged 1 to 3 year old: 15 ml, orally taken three times daily; children aged 3 to 5 year old: 20 ml, orally taken three times daily;
• Zhi Ke San
children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
• Hua Tan San
children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
• Guaifenesin Syrup
children aged 6 months to 1 year old: 3ml, orally taken three times daily; children aged 1 to 3 year old: 5ml, orally taken three times daily; children aged 3 to 5 year old: 8ml, orally taken three times daily;
• Ibuprofen Suspension
taken under prescription
• salbutamol
taken under prescription

Locations

Country	Name	City	State
China	Affiliated Children's Hospital of Capital University of Medical Sciences	Beijing	Beijing
China	Affiliated Children's Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangzhou Children's Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Shandong University of TCM	Ji'nan	Shandong
China	Affiliated Longhua Hospital of Shanghai University of TCM	Shanghai	Shanghai
China	Affiliated Hospital of Liaoning University of TCM	Shenyang	Liaoning

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, related to treatment in hospital	observed during treatment in 10 days	No
Primary	Cured rate	Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.	Every day since receiving treatment, all together 10 days (times)	No
Primary	Effectiveness time window	days range from treatment is received to the effectiveness is observed, and symptoms disappear	Every day since receiving treatment, all together 10 days (times)	No
Secondary	TCM syndrome scores and effective rate	Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate	10 days	No
Secondary	Effect in fever, cough, phlegm and gasp	temperature, fever frequency, fever lasting time, Ibuprofen Suspension dosing; cough severity; phlegm amount, color and nature; gasp frequency, severity, all to be measured	10 days	No
Secondary	Time of lung rales disappear completely	days are counted since receiving treatment, when the chest radiograph returns to normal	10 days	No
Secondary	Check-out time	days counted when the patient checks out	10 days	No
Secondary	Pulmonary disease incidence	unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up	30 days	No