Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT06930157
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 624}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Recurrence Rate', 'timeFrame': 'At 3 years after enrollment', 'description': 'The proportion of participants with adenoma recurrence, compared between experimental and control groups, confirmed by colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Rate of Advanced Adenoma or Cancer Development', 'timeFrame': 'At 3 years after enrollment', 'description': 'The proportion of participants who develop advanced adenomas or colorectal cancer, comparing between experimental and control groups'}, {'measure': 'TCM Syndrome Survey', 'timeFrame': 'At baseline, 6 months, 12 months, 18 months， 24 months and 36 months', 'description': 'The Traditional Chinese Medicine Syndrome Survey assesses bowel habits, abdominal symptoms, and secondary symptoms like oral discomfort and appetite, with scores ranging from 0 (no symptoms) to higher values indicating increasing severity, alongside tongue and pulse observations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low-risk Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Shenling Baizhu granules can prevent colorectal adenoma from coming back in people who had low-risk colorectal adenomas removed. The main questions it aims to answer are:\n\n* Can Shenling Baizhu granules lower the rate of colorectal adenoma returning after removal?\n* How safe is Shenling Baizhu granules when used long-term for preventing adenoma?\n* Which patients are most likely to benefit from this treatment?\n\nResearchers will compare Shenling Baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning.\n\nParticipants will:\n\n* Take Shenling Baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months\n* Have regular check-ups and provide blood, stool, saliva, and tissue samples\n* Get a colonoscopy after 3 years to check if any adenomas have returned\n* Fill out questionnaires about their symptoms and overall health throughout the study\n\nThis study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. The total study duration is 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with low-risk colorectal adenoma\n* Complete colonoscopy examination (adequate bowel preparation, cecal intubation, withdrawal time \\>6 minutes), with endoscopic resection performed including snare polypectomy, EMR, EPMR, ESD\n* Within 1 month after adenoma resection\n* Age 18-70 years\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Incomplete adenoma resection\n* Long-term use of aspirin, folic acid, calcium, or vitamin D supplements\n* Familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch syndrome), or other hereditary polyposis syndromes\n* Severe inflammatory bowel disease\n* History of malignancy within past 5 years (excluding basal cell carcinoma of the skin and/or cervical intraepithelial neoplasia after surgery)\n* Pregnant or lactating women\n* Severe cardiovascular disease, cerebrovascular disease, liver or kidney dysfunction, or diabetes\n* Severe mental illness that prevents compliance with colonoscopy examination'}, 'identificationModule': {'nctId': 'NCT06930157', 'briefTitle': 'Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Shenling Baizhu Granules in Preventing Recurrence of Low-Risk Colorectal Adenoma', 'orgStudyIdInfo': {'id': 'KY2024-191-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group (Shenling Baizhu Granules)', 'description': 'Participants will take Shenling Baizhu granules (6 grams, 3 times daily) for 6 months, along with basic health education.', 'interventionNames': ['Drug: Shenling Baizhu granules (TCM patent medicine)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (No intervention)', 'description': 'Participants will receive only basic health education without taking Shenling Baizhu granules.'}], 'interventions': [{'name': 'Shenling Baizhu granules (TCM patent medicine)', 'type': 'DRUG', 'description': 'Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 grams orally three times daily, before or with meals, for a period of 6 months. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.', 'armGroupLabels': ['Experimental Group (Shenling Baizhu Granules)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaobo Li', 'role': 'CONTACT', 'email': 'lxb_1969@163.com', 'phone': '+86021-58752345'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}