Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT07066059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative intestinal function recovery time', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Observe and record the postoperative intestinal function recovery time of the two groups of patients (including the time of first exhaust and defecation). The shorter the time, the better.'}, {'measure': 'Total duration of intestinal function recovery', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Observe and record the total duration of intestinal function recovery of the two groups of patients. The shorter the time, the better.'}, {'measure': 'Defecation trait score', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Observe and record the defecation trait score of the two groups of patients (using the Bristol Stool Scale). Seven types of stools based on shape and consistency, with type 1 being the hardest and type 7 being the softest'}, {'measure': 'Levels of inflammatory factors', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Measure the levels of inflammatory factors (such as IL-6, TNF-α, etc.).'}], 'secondaryOutcomes': [{'measure': 'Adverse event rate', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Record adverse events occurring in the two groups of patients during the study period, including gastrointestinal discomfort (nausea, vomiting, abdominal pain, etc.), changes in liver and kidney function indicators, etc.'}, {'measure': 'Comfort of intestinal preparation satisfaction questionnaire', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Evaluate the differences in comfort of intestinal preparation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.'}, {'measure': 'Postoperative defecation satisfaction questionnaire', 'timeFrame': 'Throughout the study drug treatment period, about 2 weeks', 'description': 'Evaluate the differences in postoperative defecation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Period']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:\n\nCan Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.\n\nParticipants will:\n\nTake Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).\n\nHave their exhaust/defecation status recorded every 6 hours postoperatively. Undergo blood tests for liver/kidney function and inflammatory factors on the day before surgery and day 3 postoperatively.\n\nComplete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 18-70 years, regardless of gender;\n2. ASA class I-III, elective surgery patients;\n3. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Disease-related exclusions:\n\n Digestive system diseases: intestinal obstruction, intestinal perforation, acute peritonitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); gastrointestinal tumors (primary or metastatic); severe hemorrhoids or anal fissures (grade Ⅲ-Ⅳ); severe liver disease (Child-Pugh class ≥ B); Other systemic diseases: severe cardiovascular diseases (cardiac function grade Ⅲ or above, severe arrhythmia); uncontrolled diabetes (fasting blood glucose \\> 11.1 mmol/L); autoimmune diseases (such as active systemic lupus erythematosus, rheumatoid arthritis); advanced malignant tumors or during radiotherapy/chemotherapy.\n2. Liver and kidney function abnormalities:\n\n Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 times the upper limit of normal (ULN); serum creatinine (Cr) \\> 1.5 times ULN; estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m².\n3. Medication-related exclusions:\n\n Use of the following drugs within the past 2 weeks:\n\n Laxatives (e.g., lactulose, polyethylene glycol), gastrointestinal motility agents (e.g., domperidone, mosapride), antibiotics (systemic use), opioid analgesics, anticholinergic drugs, long-term laxative use (continuous use ≥ 2 weeks), preoperative use of enteral nutrition preparations or intravenous nutritional support.\n4. Exclusions for special populations:\n\n Pregnant or lactating women; those allergic to components of Shouhui Tongbian Capsules (including Chinese herbal ingredients such as ginseng, atractylodes, polygonum multiflorum); patients with mental disorders or cognitive impairment; emergency or urgent surgery patients; those with an expected postoperative hospital stay \\< 3 days.\n5. Other exclusions:\n\nParticipation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT07066059', 'briefTitle': 'Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period', 'orgStudyIdInfo': {'id': 'SDU-2025-XM-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Treatment group', 'description': 'Receive routine perioperative care including diet control and standard bowel-cleansing drugs'}, {'type': 'EXPERIMENTAL', 'label': 'Shouhui Tongbian Capsules group', 'description': 'Receive Shouhui Tongbian Capsules', 'interventionNames': ['Drug: Shouhui Tongbian Capsules']}], 'interventions': [{'name': 'Shouhui Tongbian Capsules', 'type': 'DRUG', 'description': '2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen', 'armGroupLabels': ['Shouhui Tongbian Capsules group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'country': 'China', 'contacts': [{'name': 'Qiang Zhang', 'role': 'CONTACT', 'email': 'zq-9999@163.com', 'phone': '+8615562659602'}], 'facility': 'Shandong Public Health Clinical Center', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}], 'overallOfficials': [{'name': 'Qiang Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Public Health Clinical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong Public Health Clinical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}