[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587811":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":57,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":41,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":92,"whyStopped":41,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Dongzhimen Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fuzheng Tongfu Jiedu prescription (FZTFJD)","EXPERIMENTAL","Basic treatment + Fuzheng Tongfu Jiedu prescription",[13],"Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Basic treatment + Fuzheng Tongfu Jiedu prescription placebo",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the \"2021 International Guidelines for the Management of Sepsis and Septic Shock.\" . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.",[9],[26],"Conventional Western medical treatment",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the \"2021 International Guidelines for the Management of Sepsis and Septic Shock.\" . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.",[15],[26],[32],{"name":33,"affiliation":34,"role":35},"Jin Liu, Dr","ICU Dongzhimen Hospital","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Xue ting Han","CONTACT","+86-01084012709",null,"529607340@qq.com",[44],{"facility":45,"status":41,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":41},"Ethics Committee of Dongzhimen Hospital","Beijing","Beijing Municipality","100700","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","ljhly05","Doctor",[62],{"name":63,"class":6},"Beijing University of Chinese Medicine","100587811","phase-1-efficacy-of-fuzheng-tongfu-jiedu-prescription-for-treating-gastrointestinal-dysfunction-associated-with-sepsis-100587811",false,"NCT06933238","Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis","The Clinical Effect and Mechanism of Fuzheng Tongfu Jiedu Prescription Regulating Cell Pyrodeath in the Treatment of Gastrointestinal Dysfunction in Sepsis Based on mtDNA\u002FNLRP3\u002FCaspase-1\u002FGSDMD Signaling Pathway","FZTFJD","Inclusion Criteria:\n\n1. Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.\n2. 50-90 years old, regardless of gender.\n3. Sequential Organ Failure Assessment (SOFA) score ≥ 2.\n4. Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.\n5. Voluntary participation with signed informed consent.\n\nExclusion Criteria:\n\n1. ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.\n2. Patients with allergies or allergic constitution to the investigational herbal medications.\n3. Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight \\> 150 kg), trauma, or surgical factors.\n4. Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.\n5. History of gastrointestinal surgery.\n6. Long-term use of corticosteroids or immunosuppressants.\n7. Severe psychiatric disorders or inability to cooperate with trial protocols.\n8. Participation in other clinical trials within 30 days.\n9. Pregnant or lactating women.\n10. Participated in other clinical studies in the past 3 months.","ALL","50 Years","90 Years",{"count":76,"type":77},70,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This study is a single-center, randomized, double-blind, placebo-controlled trial.",[84,85,86],"Sepsis Abdominal","Gastrointestinal Dysfunction","Traditional Chinese Medicine",[88,89,90,91],"gastrointestinal dysfunction","sepsis","Traditional Chinese medicine","Fuzheng Tongfu Jiedu Decoction","NOT_YET_RECRUITING","2025-04-11",{"date":95,"type":96},"2025-04-18","ACTUAL",{"date":98,"type":77},"2025-04-25",{"date":100,"type":77},"2026-06-30",{"name":5,"class":6},1]