Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT04225559
Status:
UNKNOWN
Last Update Posted:
2020-05-01
First Post:
2019-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4632}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2019-12-29', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rome IV functional gastrointestinal disease diagnosis questionnaire', 'timeFrame': 'baseline', 'description': "Fill in only at the time of the patient's consultation, to assess the patient's current situation.Investigation of patients with functional gastrointestinal symptoms according to Rome IV diagnostic criteria.Determine the type of disease based on the questionnaire."}], 'secondaryOutcomes': [{'measure': 'PHQ-15 Scale', 'timeFrame': 'baseline', 'description': "Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from of physical symptoms in patients with functional gastrointestinal disorders from 15 aspects. 0-4 points: very mild， 5-9 points: mild ，10-14 points: moderate，15-30 points: severe."}, {'measure': 'SF-36 Scale', 'timeFrame': 'baseline', 'description': "Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects."}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'baseline', 'description': "Fill in only at the time of the patient's consultation, to assess the patient's current situation.Scoring to determine if a patient has symptoms of anxiety and depression：(0-7: asymptomatic， 8-10: suspicious symptoms， 11-21: there must be symptoms)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['To Analyze TCM Syndrome and Symptoms of FGIDs Patients']}, 'descriptionModule': {'briefSummary': 'To analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of Chinese medicine in patients with FGIDs in Chinese Grade-A Tertiary Hospitals.\n\nThe characteristics of TCM（Traditional Chinese Medicine） syndromes and symptoms of the above-mentioned FGIDs will be analyzed, and the characteristics of TCM syndromes of FGIDs and their possible relationship with FGIDs subtypes will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients in Chinese Grade-A tertiary hospitals who has been diagnosed FGIDs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptoms has appeared for at least 3 months;\n2. No organic disease and gastrointestinal alarm symptoms, which meet the diagnostic criteria of FGIDs;\n3. Sign informed consent and be able to read and understand the questionnaire.\n\nExclusion Criteria:\n\n1. A history of organic gastrointestinal diseases;\n2. Alarm symptoms of digestive tract (such as melena, weight loss, fever, abdominal mass, ascites, anemia, family history of gastrointestinal tumors, etc.)\n3. Have a history of mental diseases;\n4. Unable to read and understand the questionnaire.'}, 'identificationModule': {'nctId': 'NCT04225559', 'briefTitle': 'Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China', 'organization': {'class': 'OTHER', 'fullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China', 'orgStudyIdInfo': {'id': 'XL018'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengyun Wang, MD', 'role': 'CONTACT', 'email': 'wfy811@163.com', 'phone': '010-86-62835610'}], 'facility': 'Xiyuan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100010', 'city': 'Dongcheng', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongbing Wang', 'role': 'CONTACT'}], 'facility': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University'}, {'zip': '100053', 'city': 'Xicheng', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Zhou', 'role': 'CONTACT'}], 'facility': "Guang'anmen Hospital,China Academy of Chinese Medical Science"}, {'zip': '510006', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaogang Huang', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Liuchow', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Zhou', 'role': 'CONTACT'}], 'facility': 'Liuzhou Traditional Chinese Medical Hospital', 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suping Ma', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Henan University of Chinese Medicine', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayao Yang', 'role': 'CONTACT'}], 'facility': 'Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL)', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yuxia wei', 'role': 'CONTACT'}], 'facility': 'Inner Mongolia Autonomous Region Hospital Chinese Medicne', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bai Ye', 'role': 'CONTACT'}], 'facility': 'Jiangsu Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang Bai', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '712000', 'city': 'Xianyang', 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiehong Wang', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Shaanxi, University of Chinese Medicine,', 'geoPoint': {'lat': 34.33778, 'lon': 108.70261}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianye Yuan', 'role': 'CONTACT'}], 'facility': 'Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juanping Su', 'role': 'CONTACT'}], 'facility': 'Shanxi Provincial Hospital Of Traditional Chinese Medicine', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenghua Zhou', 'role': 'CONTACT'}], 'facility': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lidan Zhong', 'role': 'CONTACT'}], 'facility': 'Hong Kong Chinese Medicine Clinical Study Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lidan Zhong', 'role': 'CONTACT'}], 'facility': 'School of Chinese Medicine,Hong Kong Baptist University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Fengyun Wang, Medical Doctor', 'role': 'CONTACT', 'email': 'wfy811@163.com', 'phone': '86-010-62835610'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}