Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:46 AM
Study NCT ID:
NCT07339956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Gut Microbiota Before and After Treatment in Two Groups of Patients', 'timeFrame': 'two weeks of intervention'}], 'primaryOutcomes': [{'measure': 'The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.', 'timeFrame': 'two weeks of intervention'}], 'secondaryOutcomes': [{'measure': 'Time required for fecal occult blood to turn negative in two groups of patients.', 'timeFrame': 'two weeks of intervention'}, {'measure': 'The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.', 'timeFrame': '3 days of intervention'}, {'measure': 'The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.', 'timeFrame': 'one week of intervention'}, {'measure': 'Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.', 'timeFrame': 'two weeks of intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antithrombotic therapy', 'Traditional Chinese Medicine'], 'conditions': ['Gastrointestinal Bleeding']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is:\n\nDoes Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests.\n\nParticipants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oral therapy with at least one antiplatelet or anticoagulant agent, including: aspirin, clopidogrel, ticagrelor, prasugrel, warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.;\n* BARC stage 1 or 2;\n* Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome;\n* Age 18-90 years;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with gastrointestinal bleeding resulting in hemoglobin levels \\<20 g/L and/or requiring hospitalization;\n* Gastrointestinal malignancies;\n* Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from hemorrhoids;\n* Concurrent use of hemostatic traditional Chinese medicine preparations like Yunnan Baiyao;\n* Significant liver or kidney dysfunction, with ALT, AST, or serum creatinine exceeding three times the upper limit of normal;\n* Pregnant women, women planning pregnancy, or lactating women;\n* Individuals deemed unsuitable for this clinical trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT07339956', 'briefTitle': 'Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-NHLHCRF-PY-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment', 'Drug: Rabeprazole Enteric-Coated Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Rabeprazole Enteric-Coated Tablets']}], 'interventions': [{'name': 'A Chinese herb formula--Yiwei Jiaohuang Onitment', 'type': 'DRUG', 'description': 'Yiwei Jiaohuang Onitment consists of four Chinese herbs: 3g of Duyiwei（Lamiophlomis Herb）, 3g of raw Da Huang(Rhubarb Root and Rhizome (Unprocessed)), 6g of Bai Ji(Bletilla Rhizome) and 10g of Ejiao (donkey-hide gelatin). Prepared as ointment, patients should take one dose daily in the morning on an empty stomach for 2 weeks.', 'armGroupLabels': ['Intervention']}, {'name': 'Rabeprazole Enteric-Coated Tablets', 'type': 'DRUG', 'description': 'Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Jie Zhang', 'role': 'CONTACT', 'email': 'zhangjie9496@bucm.edu.cn', 'phone': '+86 15652385971'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Zhang', 'role': 'CONTACT', 'email': 'zhangjie9496@bucm.edu.cn', 'phone': '+86 15652385971'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Jie, Zhang', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}