AzTrials
AzTrials

PneumoniaNCT02069665

Effectiveness Study of Integrative Treatment for Pediatric Pneumonia

A study testing Fuxiong San, Xiyanping injection and Ribavirin Injection in people with Pneumonia, run by Liaoning University of Traditional Chinese Medicine at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Pneumonia
What is being tested?
Fuxiong San, Xiyanping injection and Ribavirin Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
6 sitesChina
Study dates
Dec 2011to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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;

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Affiliated Children's Hospital of Capital University of Medical Sciences

    Beijing, Beijing Municipality, 100045

  • Affiliated Children's Hospital of Dalian Medical University

    Dalian, Liaoning, 116044

  • Guangzhou Children's Hospital

    Guangzhou, Guangdong, 510120

  • Affiliated Hospital of Shandong University of TCM

    Ji'nan, Shandong, 250011

  • Affiliated Longhua Hospital of Shanghai University of TCM

    Shanghai, Shanghai Municipality, 200032

  • Affiliated Hospital of Liaoning University of TCM

    Shenyang, Liaoning, 110032

Other trials in China

About this study

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

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.

Read the detailed 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).

Conditions
Pneumonia
Being tested
Fuxiong San, Xiyanping injection, Ribavirin Injection, Xiaoer Qingfei Heji (mixture), Zhi Ke San
Keywords
pneumonia, pediatrics, viral
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fuxiong SanOther

    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 injectionDrug

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

  • Ribavirin InjectionDrug

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

  • 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;

  • Zhi Ke SanDrug

    Also called herbal powder to relieve cough

    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 SanDrug

    Also called herbal powder to remove phlegm

    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 SyrupDrug

    Also called Guaifenesin, Methylephedrine and Chlorphenamine 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 SuspensionDrug

    Also called Motrin

    taken under prescription

  • salbutamolDrug

    Also called β2-agonists

    taken under prescription

Study groups in NCT02069665
Study groupRoleWhat they receive
Injection, medications and applicationExperimentalIntravenous 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
Receives: Other: Fuxiong San; Drug: Xiyanping injection; Drug: Xiaoer Qingfei Heji (mixture); Drug: Zhi Ke San; Drug: Hua Tan San
Injection and medicationsActive comparatorIntravenous injection: Ribavirin Injection; Medications: symptomatic therapies * Guaifenesin Syrup, for removing phlegm, relieving gasp-cough; * Ibuprofen Suspension, and salbutamol in case of different symptoms
Receives: Drug: Ribavirin Injection; Drug: Guaifenesin Syrup; Drug: Ibuprofen Suspension; Drug: salbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cured rate

    Clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded.

    Measured: Every day since receiving treatment, all together 10 days (times)

  2. Effectiveness time window

    days range from treatment is received to the effectiveness is observed, and symptoms disappear

    Measured: Every day since receiving treatment, all together 10 days (times)

Secondary outcomes (5)

  1. TCM syndrome scores and effective rate

    Total effective rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate

    Measured: 10 days

  2. 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

    Measured: 10 days

  3. Time of lung rales disappear completely

    days are counted since receiving treatment, when the chest radiograph returns to normal

    Measured: 10 days

  4. Check-out time

    days counted when the patient checks out

    Measured: 10 days

  5. Pulmonary disease incidence

    unresolved pneumonia, chronic cough, cough variant asthma incidence in the follow-up

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2014 (estimated)
  2. Study startDec 2011
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02069665
Sponsor's protocol ID
AHLN-TCM-01
Status last verified
Feb 2014
First submitted
26 Dec 2013
Last updated
24 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Fuxiong San, Xiyanping injection and Ribavirin Injection in people with Pneumonia, run by Liaoning University of Traditional Chinese Medicine at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cured rate (time frame: Every day since receiving treatment, all together 10 days (times)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02069665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in