Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Injection, medications and application

Intravenous injection: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co., Ltd;

Medications: according to TCM syndrome differentiations;

* Wind-heat blocking lungs pattern (feng re bi fei zheng): Xiaoer Qingfei Heji (mixture), and Zhi Ke San (herbal powder to relieve cough)
* Phlegm-heat blocking lungs pattern (tan re bi fei zheng): Xiaoer Qingfei Heji (mixture), and Hua Tan San (herbal powder to remove phlegm)

External application: Fuxiong San

Group Type EXPERIMENTAL

Fuxiong San

Intervention Type OTHER

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

Xiyanping injection

Intervention Type DRUG

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

Xiaoer Qingfei Heji (mixture)

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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;

Injection and medications

Intravenous injection: Ribavirin Injection;

Medications: symptomatic therapies

* Guaifenesin Syrup, for removing phlegm, relieving gasp-cough;
* Ibuprofen Suspension, and salbutamol in case of different symptoms

Group Type ACTIVE_COMPARATOR

Ribavirin Injection

Intervention Type DRUG

ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.

Guaifenesin Syrup

Intervention Type DRUG

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

Intervention Type DRUG

taken under prescription

salbutamol

Intervention Type DRUG

taken under prescription

Interventions

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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

Intervention Type OTHER

Xiyanping injection

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

Intervention Type DRUG

Ribavirin Injection

ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.

Intervention Type DRUG

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;

Intervention Type DRUG

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;

Intervention Type DRUG

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;

Intervention Type DRUG

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;

Intervention Type DRUG

Ibuprofen Suspension

taken under prescription

Intervention Type DRUG

salbutamol

taken under prescription

Intervention Type DRUG

Other Intervention Names

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herbal powder to relieve cough herbal powder to remove phlegm Guaifenesin, Methylephedrine and Chlorphenamine Syrup Motrin β2-agonists

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No