[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548975":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":77,"collaborators":43,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":43,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":43,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HXLS group","EXPERIMENTAL","The HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthamus tinctorius L, 6.0g).",[13],"Drug: Chinese Herbal formula HuoXue LiShui",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo group","PLACEBO_COMPARATOR","The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (28.0g)",[19],"Drug: Chinese Herbal formula Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Chinese Herbal formula HuoXue LiShui","The intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonuri Herbal, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthami Flos, 6.0g).",[9],[27],"HuoXue LiShui",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Chinese Herbal formula Placebo","The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g)",[15],[33],"Placebo",[35],{"name":36,"affiliation":5,"role":37},"Weiming Liu, M.D.","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Liang Wu, M.D.","CONTACT","15001333582",null,"wuliang@bjtth.org",{"name":36,"role":41,"phone":46,"phoneExt":43,"email":47},"13701182770","liuweimingnsok@sina.com",[49,62,71],{"facility":50,"status":43,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":43},"Beijing Luhe Hospital, Capital Medical University","Beijing","Beijing Municipality","101100","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},{"facility":63,"status":43,"city":64,"state":65,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":66,"geoPoint":70,"contacts":43},"First People's Hospital of Lianyungang","Lianyungang","Jiangsu",{"type":57,"coordinates":67},[68,69],119.21556,34.59845,{"lat":69,"lon":68},{"facility":72,"status":43,"city":51,"state":43,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":76,"contacts":43},"Beijing Tiantan Hospital, Capital Medical University","100070",{"type":57,"coordinates":75},[59,60],{"lat":60,"lon":59},{"type":37,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Weiming Liu","Professor","100548975","efficacy-and-safety-of-chinese-herbal-huoxue-lishui-formula-for-chronic-subdural-hematoma-100548975",false,"NCT06427980","Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma","Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail","CHARM","Inclusion Criteria:\n\n1. Age between 18 and 90 years and either gender will be included.\n2. Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).\n3. Primary hematoma or residual hematoma after burr-hole drainage.\n4. Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.\n5. No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.\n6. Written informed consent will be obtained from patients or their next of kins according to their cognitive status.\n\nExclusion Criteria:\n\n1. Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.\n2. Progressive or apparent neurological deficit with a GCS score \\\u003C 14 or mRS score \\> 2.\n3. Midline shift \\> 10 mm on the radiological image.\n4. Previous medication treatment for CSDH.\n5. Previous intracranial surgery for any other neurological disorder.\n6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.\n7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.\n8. Malignant tumors.\n9. Life expectancy of \\\u003C 1 year.\n10. Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase \\> 120 U\u002FL).\n11. Severe renal impairment (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin or serum creatinine \\> 150 μmol\u002FL).\n12. Moderate or severe anemia (hemoglobin ≤ 90 g\u002FL).\n13. Severe coagulopathy or a high risk of life-threatening bleeding.\n14. Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.\n15. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.\n16. Difficulty swallowing oral medication.\n17. Pregnancy or lactation.\n18. Participating in another study.","ALL","18 Years","90 Years",{"count":92,"type":93},160,"ESTIMATED","INTERVENTIONAL",[96],"NA","A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.",[99],"Chronic Subdural Hematoma",[99,101,27,102,103],"Chinese herbal formula","Pharmacotherapy","Randomized controlled trial","NOT_YET_RECRUITING","2024-12-26",{"date":107,"type":108},"2024-12-30","ACTUAL",{"date":110,"type":93},"2025-02-01",{"date":112,"type":93},"2026-03-28",{"name":5,"class":6},3]