Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

Liaoning University of Traditional Chinese Medicine

Status: Completed

Conditions: Pneumonia

Treatments: Drug: Guaifenesin Syrup; Drug: Ibuprofen Suspension; Drug: salbutamol; Drug: Hua Tan San; Drug: Ribavirin Injection; Drug: Xiaoer Qingfei Heji (mixture); Drug: Zhi Ke San; Drug: Xiyanping injection; Other: Fuxiong San

Study type: Interventional

Funder types: Other

Identifiers

NCT02069665

AHLN-TCM-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 451 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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451 participants in 2 patient groups

Injection, medications and application

Experimental group

Description:

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

Treatment:

Drug: Xiyanping injection

Drug: Xiaoer Qingfei Heji (mixture)

Other: Fuxiong San

Drug: Zhi Ke San

Drug: Hua Tan San

Injection and medications

Active Comparator group

Description:

Intravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms

Treatment:

Drug: Ribavirin Injection

Drug: salbutamol

Drug: Ibuprofen Suspension

Drug: Guaifenesin Syrup