Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-14 @ 12:53 AM
Study NCT ID:
NCT02362906
Status:
UNKNOWN
Last Update Posted:
2015-02-13
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097909', 'term': 'Second Generation Cephalosporins'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D000097902', 'term': 'beta Lactam Antibiotics'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'direct medical cost', 'timeFrame': 'observed during treatment in 7 days', 'description': 'medical cost including hospital expenses, examine fee, medication fee, et al, relate to treatment in hospital'}], 'primaryOutcomes': [{'measure': 'Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded)', 'timeFrame': 'every day since receiving treatment,all together 7 days (times)', 'description': 'clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded'}, {'measure': 'effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear)', 'timeFrame': 'every day since receiving treatment, all together 7 days (times)', 'description': 'days range from treatment is received to the effectiveness is observed, and symptoms disappear'}], 'secondaryOutcomes': [{'measure': 'effect in treating fever', 'timeFrame': '7 days', 'description': 'temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured'}, {'measure': 'effect in dyspnea releasing', 'timeFrame': '7 days', 'description': 'gasp frequency, severity, all to be measured'}, {'measure': 'effect in phlegm releasing', 'timeFrame': '7 days', 'description': 'phlegm amount,color and nature to be measured'}, {'measure': 'effect in cough releasing', 'timeFrame': '7 days', 'description': 'cough severity to be measured'}, {'measure': 'time from admission to recovery of rales', 'timeFrame': '7 days'}, {'measure': 'TCM syndrome scores', 'timeFrame': '7 days', 'description': 'measure is a composite.'}, {'measure': 'effective rate of TCM syndrome scores', 'timeFrame': '7 days', 'description': 'total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate'}, {'measure': 'check-out time (days counted when the patient checks out)', 'timeFrame': '7 days', 'description': 'days counted when the patient checks out'}, {'measure': 'pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up)', 'timeFrame': '15 days; 30 days; 90 days', 'description': 'prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up'}, {'measure': 'safety (With adverse events as the calculation basis)', 'timeFrame': '7 days', 'description': 'With adverse events as the calculation basis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pneumonia', 'pediatrics'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children,aged 1 to 14 years old;\n* diagnosed as pneumonia according to western medicine diagnostic criteria;\n* 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);\n* disease progression within 72 hours; those whose guardians understood and assigned the informed consent;\n\nExclusion Criteria:\n\n* severe pneumonia;\n* complicated with other Pulmonary Disorders attack other than pneumonia;\n* 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;\n* allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months;\n* those who intend to lost follow-up by practitioners' judgment."}, 'identificationModule': {'nctId': 'NCT02362906', 'briefTitle': 'Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Liaoning University of Traditional Chinese Medicine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '201307007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection,medications and application', 'description': 'Intravenous injection:\n\nbacterial 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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Injection and medications', 'description': 'Intravenous injection:\n\nbacterial 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.', 'interventionNames': ['Drug: Xiyanping injection', 'Drug: wind-heat formula granules', 'Drug: phlegm-heat formula granules', 'Drug: second generation cephalosporin', 'Drug: Erythromycin', 'Drug: Azithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'Injection and application', 'description': 'Intravenous injection:\n\nbacterial 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.', 'interventionNames': ['Drug: Xiyanping injection', 'Drug: Fu-xiong San', 'Drug: second generation cephalosporin', 'Drug: Erythromycin', 'Drug: Azithromycin']}], 'interventions': [{'name': 'Xiyanping injection', 'type': 'DRUG', 'description': 'ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection', 'armGroupLabels': ['Injection and application', 'Injection and medications', 'Injection,medications and application']}, {'name': 'wind-heat formula granules', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Injection and medications', 'Injection,medications and application']}, {'name': 'phlegm-heat formula granules', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Injection and medications', 'Injection,medications and application']}, {'name': 'Fu-xiong San', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Injection and application', 'Injection,medications and application']}, {'name': 'second generation cephalosporin', 'type': 'DRUG', 'armGroupLabels': ['Injection and application', 'Injection and medications', 'Injection,medications and application']}, {'name': 'Erythromycin', 'type': 'DRUG', 'description': 'ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection', 'armGroupLabels': ['Injection and application', 'Injection and medications', 'Injection,medications and application']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': 'ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection', 'armGroupLabels': ['Injection and application', 'Injection and medications', 'Injection,medications and application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kunling Shen, Ph. D', 'role': 'CONTACT', 'phone': '0086-13910727586'}, {'name': 'Kunling Shen, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Affiliated Children's Hospital of Capital University of Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "Li Deng, Master's", 'role': 'CONTACT', 'phone': '0086-13711220382'}, {'name': "Li Deng, Master's", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guangzhou Children's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Xu, Ph.D', 'role': 'CONTACT', 'phone': '13724885258'}], 'facility': 'Affiliated hospital of Guangzhou university of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530023', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lining Wang, Ph.D', 'role': 'CONTACT', 'phone': '13607717743'}], 'facility': 'Affiliated Hospital of Guangxi University of Chinese Medicine', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '130103', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaochun Feng, Ph.D', 'role': 'CONTACT', 'phone': '13578696998'}], 'facility': 'Affiliated Hospital of Changchun University of TCM', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '116044', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenze Cui, Ph. D', 'role': 'CONTACT', 'phone': '0086-13904084058'}, {'name': 'Zhenze Cui, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Affiliated Children's Hospital of Dalian Medical University", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '110032', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuefeng Wang, Ph.D.', 'role': 'CONTACT', 'phone': '0086-13840208807'}, {'name': 'Xuefeng Wang, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Liaoning University of TCM', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250011', 'city': "Ji'nan", 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanning Li, Ph. D', 'role': 'CONTACT', 'phone': '0086-13905313077'}, {'name': 'Yanning Li, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Shandong University of TCM'}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "Zhiyan Jiang, Bachelor's", 'role': 'CONTACT', 'phone': '0086-13801868578'}, {'name': "Zhiyan Jiang, Bachelor's", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Longhua Hospital of Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300193', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Ma, Ph.D', 'role': 'CONTACT', 'phone': '13902095399'}], 'facility': 'First teaching hospital of Tianjin university of TCM', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Xuefeng Wang, Ph.D', 'role': 'CONTACT', 'phone': '13840208807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaoning University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing University of Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Xuefeng Wang', 'investigatorAffiliation': 'Liaoning University of Traditional Chinese Medicine'}}}}