PneumoniaNCT02362906
Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
A study testing Xiyanping injection, wind-heat formula granules and phlegm-heat formula granules in people with Pneumonia, run by Liaoning University of Traditional Chinese Medicine at 10 sites in China.
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 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Xiyanping injection, wind-heat formula granules and phlegm-heat formula granules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 10 sitesChina
- Study dates
- Apr 2014to Aug 2015
- 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 1 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children,aged 1 to 14 years old;
- diagnosed as pneumonia according to western medicine diagnostic criteria;
- diagnosed as TCM pneumonia with pneumonia with dyspnea and 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
- severe pneumonia;
- complicated with other Pulmonary Disorders attack other than pneumonia;
- complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) >8.2mmol/l, or serum C reactive protein >104umol/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;
- those who intend to lost follow-up by practitioners' judgment.
Trial locations and contacts
10 sites in 1 country.
Xuefeng Wang, Ph.D contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Affiliated Children's Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, 100045
Kunling Shen, Ph. D, 0086-13910727586
Kunling Shen, Ph. D
- Recruiting
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin, 130103
Xiaochun Feng, Ph.D, 13578696998
- Recruiting
Affiliated Children's Hospital of Dalian Medical University
Dalian, Liaoning, 116044
Zhenze Cui, Ph. D, 0086-13904084058
Zhenze Cui, Ph. D
- Recruiting
Guangzhou Children's Hospital
Guangzhou, Guangdong, 510120
Li Deng, Master's, 0086-13711220382
Li Deng, Master's
- Recruiting
Affiliated hospital of Guangzhou university of Chinese Medicine
Guangzhou, Guangdong, 510405
Hua Xu, Ph.D, 13724885258
- Recruiting
Affiliated Hospital of Shandong University of TCM
Ji'nan, Shandong, 250011
Yanning Li, Ph. D, 0086-13905313077
Yanning Li, Ph. D
- Recruiting
Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023
Lining Wang, Ph.D, 13607717743
- Recruiting
Affiliated Longhua Hospital of Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Zhiyan Jiang, Bachelor's, 0086-13801868578
Zhiyan Jiang, Bachelor's
- Recruiting
Affiliated Hospital of Liaoning University of TCM
Shenyang, Liaoning, 110032
Xuefeng Wang, Ph.D., 0086-13840208807
Xuefeng Wang, Ph. D
- Recruiting
First teaching hospital of Tianjin university of TCM
Tianjin, Tianjin Municipality, 300193
Rong Ma, Ph.D, 13902095399
About this study
Official title: Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China
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 block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).
- Conditions
- Pneumonia
- Being tested
- Xiyanping injection, wind-heat formula granules, phlegm-heat formula granules, Fu-xiong San, second generation cephalosporin
- Keywords
- pneumonia, pediatrics
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiyanping injectionDrug
ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
wind-heat formula granulesDrug
children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
phlegm-heat formula granulesDrug
children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
Fu-xiong SanDrug
external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily
second generation cephalosporinDrug
ErythromycinDrug
ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
AzithromycinDrug
ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
| Study group | Role | What they receive |
|---|---|---|
| Injection,medications and application | Experimental | Intravenous injection:
bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: 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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules; external application: Fu-xiong San. Receives: Drug: Xiyanping injection; Drug: wind-heat formula granules; Drug: phlegm-heat formula granules; Drug: Fu-xiong San; Drug: second generation cephalosporin; Drug: Erythromycin; Drug: Azithromycin |
| Injection and medications | Experimental | Intravenous injection:
bacterial pneumonia：second generation cephalosporin; mycoplasma pneumonia：erythromycin or azithromycin; viral pneumonia：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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules. Receives: Drug: Xiyanping injection; Drug: wind-heat formula granules; Drug: phlegm-heat formula granules; Drug: second generation cephalosporin; Drug: Erythromycin; Drug: Azithromycin |
| Injection and application | Experimental | Intravenous injection:
bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; external application: Fu-xiong San. Receives: Drug: Xiyanping injection; Drug: Fu-xiong San; Drug: second generation cephalosporin; Drug: Erythromycin; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
Measured: every day since receiving treatment,all together 7 days (times)
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
Measured: every day since receiving treatment, all together 7 days (times)
Secondary outcomes (10)
effect in treating fever
temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured
Measured: 7 days
effect in dyspnea releasing
gasp frequency, severity, all to be measured
Measured: 7 days
effect in phlegm releasing
phlegm amount,color and nature to be measured
Measured: 7 days
effect in cough releasing
cough severity to be measured
Measured: 7 days
time from admission to recovery of rales
Measured: 7 days
TCM syndrome scores
measure is a composite.
Measured: 7 days
effective rate of TCM syndrome scores
total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate
Measured: 7 days
check-out time (days counted when the patient checks out)
days counted when the patient checks out
Measured: 7 days
pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up
Measured: 15 days; 30 days; 90 days
safety (With adverse events as the calculation basis)
With adverse events as the calculation basis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, Xuefeng Wang, Liaoning University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362906
- Sponsor's protocol ID
- 201307007
- Status last verified
- Feb 2015
- First submitted
- 22 Jan 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China
- ClinicalTrials.gov ID
- NCT02362906
- Acronym / sponsor ID
- 201307007
- Conditions
- Pneumonia
- Keywords
- pneumonia, pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection,medications and application | Experimental | Drug: Xiyanping injection, Drug: wind-heat formula granules, Drug: phlegm-heat formula granules, Drug: Fu-xiong San, Drug: second generation cephalosporin, Drug: Erythromycin, Drug: AzithromycinIntravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: 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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules; external application: Fu-xiong San. |
| Injection and medications | Experimental | Drug: Xiyanping injection, Drug: wind-heat formula granules, Drug: phlegm-heat formula granules, Drug: second generation cephalosporin, Drug: Erythromycin, Drug: AzithromycinIntravenous injection: bacterial pneumonia：second generation cephalosporin; mycoplasma pneumonia：erythromycin or azithromycin; viral pneumonia：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): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules. |
| Injection and application | Experimental | Drug: Xiyanping injection, Drug: Fu-xiong San, Drug: second generation cephalosporin, Drug: Erythromycin, Drug: AzithromycinIntravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; external application: Fu-xiong San. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children,aged 1 to 14 years old;
- diagnosed as pneumonia according to western medicine diagnostic criteria;
- diagnosed as TCM pneumonia with pneumonia with dyspnea and 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;
Key exclusion criteria (5 listed)
- severe pneumonia;
- complicated with other Pulmonary Disorders attack other than pneumonia;
- complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) >8.2mmol/l, or serum C reactive protein >104umol/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;
- those who intend to lost follow-up by practitioners' judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiyanping injectionivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection | Drug | Injection and application, Injection and medications, Injection,medications and application |
| wind-heat formula granuleschildren aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency | Drug | Injection and medications, Injection,medications and application |
| phlegm-heat formula granuleschildren aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency | Drug | Injection and medications, Injection,medications and application |
| Fu-xiong Sanexternal application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily | Drug | Injection and application, Injection,medications and application |
| second generation cephalosporin | Drug | Injection and application, Injection and medications, Injection,medications and application |
| Erythromycinivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection | Drug | Injection and application, Injection and medications, Injection,medications and application |
| Azithromycinivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection | Drug | Injection and application, Injection and medications, Injection,medications and application |
Primary outcome
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)
Time frame: every day since receiving treatment,all together 7 days (times)
clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded
effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)
Time frame: every day since receiving treatment, all together 7 days (times)
days range from treatment is received to the effectiveness is observed, and symptoms disappear
10 secondary outcomes
effect in treating fever
Time frame: 7 days
effect in dyspnea releasing
Time frame: 7 days
effect in phlegm releasing
Time frame: 7 days
effect in cough releasing
Time frame: 7 days
time from admission to recovery of rales
Time frame: 7 days
TCM syndrome scores
Time frame: 7 days
effective rate of TCM syndrome scores
Time frame: 7 days
check-out time (days counted when the patient checks out)
Time frame: 7 days
pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)
Time frame: 15 days; 30 days; 90 days
safety (With adverse events as the calculation basis)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuefeng Wang, Ph.D contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xiyanping injection, wind-heat formula granules and phlegm-heat formula granules in people with Pneumonia, run by Liaoning University of Traditional Chinese Medicine at 10 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: status not confirmed, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng Wang, Ph.D (13840208807), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded) (time frame: every day since receiving treatment,all together 7 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?
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 13 Feb 2015.