Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-31 @ 5:41 PM
Study NCT ID:
NCT07159412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication rate', 'timeFrame': 'At the end of the 12-week treatment period.', 'description': 'Patients must undergo a follow-up 13C-urea breath test (13C-UBT) after treatment completion to determine eradication success. A DOB value \\< 4‱ is considered indicative of successful eradication. The eradication rate is calculated as follows: (number of successfully eradicated patients in each group / total number of patients in that group) × 100.00%.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection', 'Metabolic-associated Steatohepatitis', 'High-dose Dual Therapy', 'Huazhi Rougan Granule']}, 'descriptionModule': {'briefSummary': 'This study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or the placebo control group. Both groups received a 2-week Hp eradication regimen consisting of vonoprazan (20 mg twice daily) and amoxicillin (1000 mg three times daily). The experimental group additionally received active Huazhi Rougan Granule (taken orally three times daily, one sachet each time, with a 6-day medication followed by a 1-day drug holiday per cycle), while the placebo control group received an identical matching placebo on the same schedule. The study aims to evaluate the synergistic therapeutic efficacy of Huazhi Rougan Granule in combination with the vonoprazan-amoxicillin dual therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-65 years;\n2. Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern;\n3. Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test);\n4. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver;\n2. Patients with severe fatty liver accompanied by ascites, edema, hyponatremia, hypokalemia, or other signs suggestive of cirrhosis; those with hepatitis or cirrhosis caused by viruses, drug toxicity, autoimmune diseases, or other factors;\n3. Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation;\n4. Pregnant or lactating women;\n5. Patients with severe primary cardiovascular, renal, or other life-threatening diseases;\n6. Individuals with a history of cancer;\n7. Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels;\n8. Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse;\n9. Those with known hypersensitivity to any component of the study drug;\n10. Participation in another clinical trial within 3 months prior to screening;\n11. Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening;\n12. Individuals deemed unsuitable for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT07159412', 'briefTitle': 'Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial of Huazhi Rougan Granule Combined With High-Dose Dual Therapy for Helicobacter Pylori Infection Complicated With Metabolic-associated Steatohepatitis (Dampness-Heat Accumulation Syndrome)', 'orgStudyIdInfo': {'id': 'KY20250819-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo']}], 'interventions': [{'name': 'Vonoprazan-amoxicillin combined with Huazhi Rougan Granule', 'type': 'DRUG', 'description': 'Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule', 'armGroupLabels': ['Intervention Group']}, {'name': 'Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo', 'type': 'DRUG', 'description': 'Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wanli Liu', 'role': 'CONTACT', 'email': '18951768998@163.com', 'phone': '18951768998'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}