Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06927258
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-15
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2025-04-13', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum interleukin-6', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}, {'measure': 'The incidence of complications', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks', 'description': 'The incidence of complications (blood in stool, perforation) and postoperative discomfort symptoms (abdominal pain, abdominal distension, diarrhea, constipation, fatigue, fever, etc.) were compared between the experimental group and the control group (primary endpoints).'}, {'measure': 'white blood cells', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}, {'measure': 'C-reactive protein', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}, {'measure': 'erythrocyte sedimentation rate', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}], 'secondaryOutcomes': [{'measure': 'hospital stay', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}, {'measure': 'hospitalization costs', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal polyps'], 'conditions': ['Colorectal Polyps']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).\n\nExclusion Criteria:\n\n* Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)'}, 'identificationModule': {'nctId': 'NCT06927258', 'briefTitle': 'Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps', 'orgStudyIdInfo': {'id': '2024-0661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The Changyanning group', 'description': 'The Changyanning group takes Changyanning granules starting from 1 day before surgery until 5 days after surgery. The granules are taken preoperatively at the same time as the first dose of laxative, and postoperatively starting after resuming an open diet.', 'interventionNames': ['Drug: changyanning granules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The control group', 'description': 'The control group does not use Changyanning granules.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'changyanning granules', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'From one day before the procedure to five days postoperatively, patients in the experimental group will be administered Chanyanning granules.', 'armGroupLabels': ['The Changyanning group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'control', 'armGroupLabels': ['The control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}