Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-07 @ 9:56 PM
Study NCT ID:
NCT03149393
Status:
UNKNOWN
Last Update Posted:
2020-02-28
First Post:
2017-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062720', 'term': 'mosapride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Main Symptom Score', 'timeFrame': 'The score will be assessed at baseline and 2 week, 4 week, 6 week.', 'description': 'The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.'}], 'secondaryOutcomes': [{'measure': 'Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale', 'timeFrame': 'The score will be assessed at baseline and 2 week, 4 week, 6 week.', 'description': "To evaluate the changes of patients' mental and psychological status"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Dyspepsia', 'Qizhi Weitong Granules', 'Traditional Chinese Medicine'], 'conditions': ['Functional Dyspepsia', 'Traditional Chinese Medicine']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.', 'detailedDescription': 'This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Metting the diagnostic criteria of functional dyspepsia in Rome IV.\n2. The subjects were informed, and the subjects voluntarily signed informed consent.\n3. The subjects have reading ability.\n\nExclusion Criteria:\n\n1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.\n2. Patients with Hp infection positive.\n3. Patients with gastroesophageal reflux disease.\n4. Patients with digestive system organic lesions.\n5. The patient had a history of stomach or abdominal surgery.\n6. Patients had taken the relevant drugs in the past 2 weeks.\n7. Patients suffering from severe illness affecting survival.\n8. Pregnant or lactating women.\n9. Participating in clinical trials of other drugs.\n10. Long term using of sedative hypnotics.\n11. Suspected or true alcohol, drug abuse history.'}, 'identificationModule': {'nctId': 'NCT03149393', 'briefTitle': 'Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules', 'organization': {'class': 'OTHER', 'fullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules', 'orgStudyIdInfo': {'id': 'Digestion-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qizhi Weitong Granules Group', 'description': 'Patients in this group will take Qizhi Weitong Granules for 8 weeks.', 'interventionNames': ['Drug: Qizhi Weitong Granules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mosapride Citrate Tablets Group', 'description': 'Patients in this group will take mosapride citrate tablets for 8 weeks.', 'interventionNames': ['Drug: Mosapride Citrate Tablets']}], 'interventions': [{'name': 'Qizhi Weitong Granules', 'type': 'DRUG', 'otherNames': ['The Treatment Group'], 'description': 'Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.', 'armGroupLabels': ['Qizhi Weitong Granules Group']}, {'name': 'Mosapride Citrate Tablets', 'type': 'DRUG', 'otherNames': ['The Control Group'], 'description': 'Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.', 'armGroupLabels': ['Mosapride Citrate Tablets Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xudong Tang, MD', 'role': 'CONTACT'}], 'facility': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wang F yun, PhD', 'role': 'CONTACT', 'email': 'wfy811@163.com', 'phone': '13522657731', 'phoneExt': '0086'}], 'overallOfficials': [{'name': 'Tang X dong, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Xiyuan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}