Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 2:14 AM
Study NCT ID:
NCT04658992
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Registration on the Use of Feilike Heji in Minors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AE', 'timeFrame': 'The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi.', 'description': 'All adverse events occurred during the study were determined according to CTCAE V5.0 for severity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All minor patients (age \\<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) and voluntarily participate in this study and meet ethical requirements.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All minor patients (age \\<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) .\n* Voluntarily participate in this study and meet ethical requirements.\n\nExclusion Criteria:\n\n* Not Applicable.'}, 'identificationModule': {'nctId': 'NCT04658992', 'briefTitle': 'The Registration on the Use of Feilike Heji in Minors', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'A Study on the Registration of the Use of Feilike Heji in Minors', 'orgStudyIdInfo': {'id': 'Feilike V2.0'}}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Liu, Prof.', 'role': 'CONTACT', 'email': 'lljjred@126.com', 'phone': '010-59616885'}], 'facility': "Beijing Children's Hospital affiliated to Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuying Mao, Bachelor', 'role': 'CONTACT', 'email': 'xiuyingmao@126.com', 'phone': '13716295500'}], 'facility': 'Beijing Pinggu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Zhou, Bachelor', 'role': 'CONTACT', 'email': '13521345341@163.com', 'phone': '13521345341'}], 'facility': 'Beijing Changping Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300450', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Yao, Bachelor', 'role': 'CONTACT', 'email': 'yao-ling1960@163.com', 'phone': '13516118161'}], 'facility': 'Peking University Binhai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuanggui Chen, Doctor', 'role': 'CONTACT', 'email': 'chenzhuanggui@126.com', 'phone': '13600009221'}], 'facility': 'The Third Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510850', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhou, Bachelor', 'role': 'CONTACT', 'email': 'zhouxin86914423@163.com', 'phone': '13926295809'}], 'facility': "The Second People's Hospital of Huadu District, Guangzhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518112', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hanhua Yang, Doctor', 'role': 'CONTACT', 'email': 'drsam@126.com', 'phone': '13537784919'}], 'facility': "Shenzhen Pingshan Women's and Children's Health Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '551700', 'city': 'Bijie', 'state': 'Guizhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'XInqian Zhao, Bachelor', 'role': 'CONTACT', 'email': '919299950@qq.com', 'phone': '18076153333'}], 'facility': "The First People's Hospital of Bijie City", 'geoPoint': {'lat': 27.30193, 'lon': 105.28627}}, {'zip': '550003', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Wang, Bachelor', 'role': 'CONTACT', 'email': '1895016299@qq.com', 'phone': '18985016299'}], 'facility': 'Guiyang Maternal and Child Health Hospital', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '150010', 'city': 'Haerbin', 'state': 'Helongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqiu Zhang, Bachelor', 'role': 'CONTACT', 'email': '13654649272@qq.com', 'phone': '13654649272'}], 'facility': "Harbin Children's Hospital"}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'XIangyun Wang, Bachelor', 'role': 'CONTACT', 'email': 'wangxiangyun@126.com', 'phone': '13973123613'}], 'facility': 'Changsha First Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zuocheng Yang, Doctor', 'role': 'CONTACT', 'email': 'yang_zcr@126.com', 'phone': '13787170289'}], 'facility': 'Xiangya San Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '412300', 'city': 'Zhuzhou', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xirong Fu, Bachelor', 'role': 'CONTACT', 'email': '2073623435@qq.com', 'phone': '13397536825'}], 'facility': "You County People's Hospital", 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Gong, Doctor', 'role': 'CONTACT', 'email': 'njgongjing@outlook.com', 'phone': '13705189604'}], 'facility': 'Second Affiliated Clinic, Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lan Li, Master', 'role': 'CONTACT', 'email': 'nclilan@163.com', 'phone': '13077913093'}], 'facility': "Jiangxi Children's Hospital", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '337100', 'city': 'Pingxiang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihao Liu, Bachelor', 'role': 'CONTACT', 'email': '1426878742@qq.com', 'phone': '15279903368'}], 'facility': 'Lotus County Maternal and Child Health Hospital', 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '114200', 'city': 'Anshan', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Haicheng Central Hospital', 'geoPoint': {'lat': 41.12361, 'lon': 122.99}}, {'zip': '118100', 'city': 'Fengcheng', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Yin, Bachelor', 'role': 'CONTACT', 'email': '867142081@qq.com', 'phone': '1394255631'}], 'facility': 'Fengcheng Central Hospital', 'geoPoint': {'lat': 40.45361, 'lon': 124.07167}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Jiang, Master', 'role': 'CONTACT', 'email': 'Jianghong724@163.com', 'phone': '13940195519'}], 'facility': 'The First Hospital affiliated with The Chinese Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250002', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Qilu Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '710032', 'city': 'Xian', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Sun, Doctor', 'role': 'CONTACT', 'email': 'sunxin001@qq.com', 'phone': '13572536262'}], 'facility': 'The First Affiliated Hospital of Air Force Military Medical University'}], 'centralContacts': [{'name': 'Jing Liu, Prof', 'role': 'CONTACT', 'email': 'lljjred@126.com', 'phone': '010-59616885'}], 'overallOfficials': [{'name': 'Jing Liu, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': "Beijing Children's Hospital affiliated to Capital Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Zhong Wang', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}}