Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-08 @ 10:11 PM
Study NCT ID:
NCT05320133
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradicaion rate', 'timeFrame': 'The forth week after the treatment.', 'description': 'The Helicobacter pylori infection status was measured by 13-carbon breath test.'}], 'secondaryOutcomes': [{'measure': 'Blood creatinine level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average blood creatinine level between two groups.'}, {'measure': 'Blood urea nitrogen level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average blood urea nitrogen level between two groups.'}, {'measure': 'eGFR', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average eGFR level between two groups.'}, {'measure': '24hrs urine protein level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average24hrs urine protein level between two groups.'}, {'measure': 'Blood presure', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average blood presure level between two groups.'}, {'measure': 'IgA level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average IgA level level between two groups.'}, {'measure': 'IgA1 level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average IgA1 level between two groups.'}, {'measure': 'Gd-IgA1 level', 'timeFrame': 'Baseline, the third and sixth month after the treatment, respectively.', 'description': 'The change of average Gd-IgA1 level level between two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'IgA nephropathy', 'Jinghua Weikang Caplsule', 'Bismuth-containing quadruple therapy', 'Eradication'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '38299639', 'type': 'DERIVED', 'citation': 'Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IgA nephropathy diagnosed by renal biopsy;\n* Current Helicobacter pylori infection;\n* Age 18-65.\n\nExclusion Criteria:\n\n* ①eGFR\\<90ml/（min·1.73m2）-\n* History of Helicobacter pylori treatment\n* Present taking hormones or immunosuppressants\n* Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa\n* Allergy history to medicines used in the study\n* History of gastric surgery\n* Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment\n* Combined with other primary or secondary nephropathy except for IgAN\n* Combined with acute renal injury\n* Female patients with pregnancy, lactation and planned pregnancy.'}, 'identificationModule': {'nctId': 'NCT05320133', 'briefTitle': 'Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study', 'orgStudyIdInfo': {'id': '2021CR36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JWC group', 'description': 'Jinghua Weikang Capsule containing quadruple therapy.', 'interventionNames': ['Drug: JWC containing quadruple therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Bismuth-containing quadruple therapy.', 'interventionNames': ['Drug: Bismuth-containing quadruple therapy']}], 'interventions': [{'name': 'JWC containing quadruple therapy', 'type': 'DRUG', 'description': 'Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.', 'armGroupLabels': ['JWC group']}, {'name': 'Bismuth-containing quadruple therapy', 'type': 'DRUG', 'description': 'Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'HUI YE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The data will be uploaded within 6 month after Dec 31, 2024.', 'ipdSharing': 'YES', 'description': 'IPD will be shared on https://clinicaltrials.gov.', 'accessCriteria': 'The user of ClinicalTrials.gov PRS could access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}