[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555611":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":42,"locations":52,"responsibleParty":69,"collaborators":71,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":46,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":46,"enrollmentInfo":88,"targetDuration":46,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":55,"whyStopped":46,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Sepsis cluster therapy + Shenhuang granules for 5 days. For the treatment of sepsis cluster, refer to the 2021 International Guidelines for Severe Sepsis and Septic Shock. Shenhuang Granules (Tianjin Hongri Pharmaceutical Co., LTD.) : 2 times a day, 1 pack each time, 100ml of warm water (temperature about 40°C) after dissolution, oral or nasal feeding (stomach tube or intestinal tube).",[13],"Drug: shenhuang granule",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Sepsis cluster therapy + placebo for 5 days. For the treatment of sepsis cluster, refer to the 2021 International Guidelines for Severe Sepsis and Septic Shock. Placebo (Tianjin Hongri Pharmaceutical Co., LTD.) : After dissolution of 100ml warm water (temperature about 40°C) in 1 pack twice a day, oral or nasal feeding (gastric tube or intestinal tube).",[19],"Drug: placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","shenhuang granule","Traditional Chinese medicine compound \"Shenhuang Granules\" is developed by Professor Fang Bangjiang, a scholar in the team of Qi-Huang, which is composed of ginseng, rhubarb, dandelion, etc., with the effect of Fuzheng Guben, clearing heat and detoxification, promoting qi and promoting blood and detumification.",[9],[27],"Tianjin Hongri Pharmaceutical Co., LTD",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"placebo","Placebo was provided by Tianjin Hongri Pharmaceutical Co., LTD., and was given orally or nasally (through gastric tube or intestinal tube) after dissolution of 100ml warm water (temperature about 40°) in 1 package twice a day.",[15],[27],[34,37,40],{"name":35,"affiliation":5,"role":36},"Wu JianNong, doctor","STUDY_CHAIR",{"name":38,"affiliation":5,"role":39},"Liu Shan, doctor","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":39},"Feng DanDan, master",[43,48],{"name":35,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","13777571598",null,"13777571598@163.com",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Meng-Yuan Shen, doctor","18261812250","1355759459@qq.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"First Affiliated Hospital of Zhejiang Chinese Medical University","RECRUITING","Hangzhou","Zhejiang","310006","China","CN",{"type":62,"coordinates":63},"Point",[64,65],120.16142,30.29365,{"lat":65,"lon":64},[68],{"name":35,"role":44,"phone":45,"phoneExt":46,"email":47},{"type":70,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[72,74,76],{"name":73,"class":6},"Zhejiang University",{"name":75,"class":6},"Red Cross Hospital, Hangzhou, China",{"name":77,"class":78},"Ningbo Hospital of Traditional Chinese Medicine","UNKNOWN","100555611","early-phase-1-evidence-based-evaluation-and-mechanism-of-shenhuang-granules-in-the-treatment-of-sepsis-100555611",false,"NCT06514339","Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis","Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis: a Randomized, Double-blind, Placebo-controlled, Effective Clinical Trial","Inclusion Criteria:\n\n* Age ≥18 years old\n* Meet the diagnostic criteria of sepsis 3.0 guidelines\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction\n* Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment\n* Patients with allergic reactions to traditional Chinese medicine\n* Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month\n* Participants in other clinical trials at the same time or within 30 days\n* Pregnant and lactating women\n* Patients with severe gastrointestinal bleeding, intestinal obstruction, or severe intraperitoneal pressure elevation (IAP≥20mmHg).","ALL","18 Years",{"count":89,"type":90},410,"ESTIMATED","INTERVENTIONAL",[93],"EARLY_PHASE1","Sepsis is a life-threatening organ dysfunction caused by the body's dysfunctional response to infection, most patients require treatment in the ICU, and is the leading cause of death worldwide. Over the years, the development of new drugs for the treatment of sepsis has failed without significant benefit in reducing mortality, and there is currently no effective drug treatment. Therefore, sepsis is a serious disease threatening the life and health of patients, causing a huge burden to society, and is a major problem in the medical field.\n\nThe pathogenesis of sepsis is complicated, and immune imbalance is the key mechanism. Suppression of host immune function may be the root cause of the increase in the long-term mortality of sepsis. Bidirectional immune regulation may be an important treatment plan to improve the survival rate and quality of life of sepsis patients. In recent years, the contribution of traditional Chinese medicine to sepsis has been highly valued at home and abroad. The treatment of sepsis by traditional Chinese medicine mainly plays the role of bidirectional immune regulation by dispelling the evil and supporting the right. Our team has achieved some results in the diagnosis and treatment of sepsis by using traditional Chinese medicine. Supported by National Natural Science Foundation of China (81774070). The team also found that magnolol can inhibit intestinal mucosal inflammation in sepsis, which was also supported by the National Natural Science Foundation of China (82174178). The team of Qhuang scholars inherit the academic experience of Zhu Liangchun, the master of Chinese medicine, warm and hot disease need not be limited to the law of wei, qi, ying, blood transmission, that is, the disease can be solved both outside and inside, breaking the three bans of warm and cold disease. On the basis of inheriting Zhu Liangchun's academic theory, the author put forward the early treatment rule of \"truncation and reversal\", and used to cleanse the \"poison\" and \"save Yin\" in the early stage of sepsis to quickly truncate the malignant development trend of sepsis. In the COVID-19 epidemic, we have found that patients with COVID-19 sepsis have \"acute deficiency syndrome\" in the early stage of clinical syndrome, which is an important factor leading to death. The clinical efficacy and mechanism of \"Shenhuang Granules\" in sepsis caused by non-novel coronavirus infection such as bacteria need to be further studied.",[96],"Sepsis",[96,98,99,100],"Shenhuang granules","Evidence-based evaluation","Effect mechanism research","2025-08-16",{"date":103,"type":104},"2025-08-22","ACTUAL",{"date":106,"type":104},"2024-07-01",{"date":108,"type":90},"2026-07-01",{"name":5,"class":6},1]