Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT06667934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms: frequency of stool', 'timeFrame': 'Follow-up for 6 months', 'description': 'Symptoms: frequency of stool in one day, or Daily number of bowel movements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': "The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:① Clinically diagnosed UC; ② The severity of UC is mild to moderate.\n\n\\-\n\nExclusion Criteria:① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06667934', 'briefTitle': 'Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine'}, 'officialTitle': 'Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis', 'orgStudyIdInfo': {'id': '2024AH-98-01'}, 'secondaryIdInfos': [{'id': '2021AH9987', 'type': 'OTHER', 'domain': 'Anhui Province key specialist project'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night', 'interventionNames': ['Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Methalazine supposers anal once a day', 'interventionNames': ['Drug: Methalazine suppository was given rectally once a day']}], 'interventions': [{'name': 'Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night', 'type': 'DRUG', 'otherNames': ['retained enema with Zuoqing powder , once a night'], 'description': 'Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night', 'armGroupLabels': ['Study Group']}, {'name': 'Methalazine suppository was given rectally once a day', 'type': 'DRUG', 'description': 'Methalazine suppository was given rectally once a day', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Heng Deng, Dr.', 'role': 'CONTACT', 'email': 'dengheng23@outlook.com', 'phone': '+8613335510159'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We can share IPD with other researchers. When our research results are phased, other research groups can watch and participate in the discussion of the research plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Heng Deng', 'investigatorAffiliation': 'The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine'}}}}