Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-18 @ 1:57 AM
Study NCT ID:
NCT03048903
Status:
UNKNOWN
Last Update Posted:
2017-02-09
First Post:
2017-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly divided into two groups ,using rheum palmatum or placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The remission rate of gastrointestinal dysfunction', 'timeFrame': '2 weeks', 'description': 'The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects'}], 'secondaryOutcomes': [{'measure': 'The ratios of L/M in human urine samples', 'timeFrame': '7 days', 'description': 'The ratios oflactulose / mannitol in human urine samples'}, {'measure': 'citrulline', 'timeFrame': '7 days', 'description': 'The contents of citrulline in human serum samples'}, {'measure': 'D- lactic acid', 'timeFrame': '7 days', 'description': 'The contents of citrulline in human serum samples'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastrointestinal dysfunction', 'sepsis', 'trauma'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '22985725', 'type': 'RESULT', 'citation': 'Kubica P, Kot-Wasik A, Wasik A, Namiesnik J, Landowski P. Modern approach for determination of lactulose, mannitol and sucrose in human urine using HPLC-MS/MS for the studies of intestinal and upper digestive tract permeability. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Oct 15;907:34-40. doi: 10.1016/j.jchromb.2012.08.031. Epub 2012 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.', 'detailedDescription': 'Patients were randomly divided into two groups, using rhubarb powder or placebo. Rhubarb is commercially certified rhubarb(Rheum palmatum, Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh, Two days before 6g, three times / day, oral or nasal feeding, two days later reduced to 3g, three times / day, oral or nasal feeding; Another group of patients taking placebo, with the same dose of Rhubarb; The overall course of the two drugs was a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:18-65 year old;\n2. Diagnosis: sepsis with gastrointestinal dysfunction (II-III grade AGI); gastrointestinal dysfunction after trauma (II-III AGI);\n3. Complete gastrointestinal tract anatomic structure（including the ileum and colon stoma）\n\nExclusion Criteria:\n\n1. Hemodynamic instability;\n2. Underlying diseases: cardiac function III\\~IV, chronic liver dysfunction Child-Pugh score \\>9 points;\n3. Less than 5 days after surgery for stomach and small intestine，less than 7 days after Colonic surgery, Postoperative gastrointestinal leakage;\n4. Abdominal Compartment Syndrome;\n5. mechanical ileus\n6. active gastrointestinal hemorrhage'}, 'identificationModule': {'nctId': 'NCT03048903', 'briefTitle': 'The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function', 'orgStudyIdInfo': {'id': 'SHCZHJJ01'}, 'secondaryIdInfos': [{'id': 'SHCZHJJ01-CDC', 'type': 'REGISTRY', 'domain': 'CHEN De-chang'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rheum Palmatum Root', 'description': 'Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)', 'interventionNames': ['Drug: Rheum Palmatum Root']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Starch Corn', 'description': 'Medical Starch is harmless to people', 'interventionNames': ['Drug: Starch Corn']}], 'interventions': [{'name': 'Rheum Palmatum Root', 'type': 'DRUG', 'otherNames': ['Chinese Rhubarb Root'], 'description': 'Rhubarb is commercially certified rhubarb(Rheum palmatum , Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.', 'armGroupLabels': ['Rheum Palmatum Root']}, {'name': 'Starch Corn', 'type': 'DRUG', 'otherNames': ['Medical Starch'], 'description': 'Starch Corn is harmless to people .The use dosage is same as Rheum Palmaturn Root.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.', 'armGroupLabels': ['Starch Corn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changzhen Hospital', 'role': 'CONTACT', 'email': '15902152684@163.com', 'phone': '021-81886999'}], 'facility': 'Shanghai ChangZheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'CHEN De chang, doctor', 'role': 'CONTACT', 'email': '18918520002@189.cn', 'phone': '8618918520002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHEN De-chang', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Intensive care unit, Principal Investigator, Clinical Professor', 'investigatorFullName': 'CHEN De-chang', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}