Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

NCT02069665 | Completed DMC

• 1 other identifier: AHLN-TCM-01
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pneumonia

Keywords

pneumonia; pediatrics; viral

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (5)

• TCM syndrome scores and effective rate

  10 days

• Effect in fever, cough, phlegm and gasp

  10 days

• Time of lung rales disappear completely

  10 days

• Check-out time

  10 days

• Pulmonary disease incidence

  30 days

Other Outcomes (1)

• Direct medical cost

  observed during treatment in 10 days

Study Arms (2)

Injection, medications and application

EXPERIMENTAL

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

Other: Fuxiong San; Drug: Xiyanping injection; Drug: Xiaoer Qingfei Heji (mixture); Drug: Zhi Ke San; Drug: Hua Tan San

Injection and medications

ACTIVE COMPARATOR

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

Drug: Ribavirin Injection; Drug: Guaifenesin Syrup; Drug: Ibuprofen Suspension; Drug: salbutamol

Interventions

Fuxiong San 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

Injection, medications and application

Xiyanping injection DRUG

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

Injection, medications and application

Ribavirin Injection DRUG

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

Injection and medications

Xiaoer Qingfei Heji (mixture) 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;

Injection, medications and application

Zhi Ke San 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;

Also known as: herbal powder to relieve cough

Injection, medications and application

Hua Tan San 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;

Also known as: herbal powder to remove phlegm

Injection, medications and application

Guaifenesin Syrup 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;

Also known as: Guaifenesin, Methylephedrine and Chlorphenamine Syrup

Injection and medications

Ibuprofen Suspension DRUG

taken under prescription

Also known as: Motrin

Injection and medications

salbutamol DRUG

taken under prescription

Also known as: β2-agonists

Injection and medications

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning University of Traditional Chinese Medicine: lead
• Beijing University of Chinese Medicine: collaborator

Study Sites (6)

Affiliated Children's Hospital of Capital University of Medical Sciences

Beijing, Beijing Municipality, 100045, China

Location

Guangzhou Children's Hospital

Guangzhou, Guangdong, 510120, China

Location

Affiliated Children's Hospital of Dalian Medical University

Dalian, Liaoning, 116044, China

Location

Affiliated Hospital of Liaoning University of TCM

Shenyang, Liaoning, 110032, China

Location

Affiliated Hospital of Shandong University of TCM

Ji'nan, Shandong, 250011, China

Location

Affiliated Longhua Hospital of Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Ribavirin; Guaifenesin; N-methylephedrine; Ibuprofen; Albuterol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Xuefeng Wang, Ph.D.

  Affiliated Hospital of Liaoning University of TCM

  STUDY DIRECTOR

• Zhenqi Wu

  Affiliated Hospital of Liaoning University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: February 24, 2014
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

CN (6)