[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647242":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":90,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":30,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":30,"studyType":110,"phases":111,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":127,"whyStopped":30,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"High-dose Bletilla formosana (BF)","EXPERIMENTAL","Participants receive 3g of Bletilla formosana powder daily for 12 weeks. To maintain blinding, the total dose is divided into two 1.5g sachets (one in the morning and one in the evening).",[13],"Drug: Bletilla formosana (BF) powder",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-dose Bletilla formosana (BF)","Participants receive 1.5g of Bletilla formosana powder and 1.5g of placebo powder daily for 12 weeks. To maintain blinding, this is administered as one active sachet and one matching placebo sachet (one in the morning and one in the evening).",[13,18],"Other: Placebo",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Participants receive 3g of inactive placebo powder daily for 12 weeks. To maintain blinding, this is administered as two matching placebo sachets (one in the morning and one in the evening).",[18],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Bletilla formosana (BF) powder","A traditional Chinese medicinal herb (Taiwanese ground orchid). The raw material is derived from the approved botanical species and medicinal part listed in the Taiwan Herbal Pharmacopoeia.",[9,15],null,{"type":6,"name":20,"description":32,"armGroupLabels":33,"otherNames":30},"An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.",[15,20],[35],{"name":36,"affiliation":5,"role":37},"Yuan-Chieh Yeh, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+886-2-24313131","6320","b9005030@cgmh.org.tw",{"name":45,"role":40,"phone":46,"phoneExt":30,"email":47},"Yu-Chieh Peng, Bachelor","+886-2-2431-2540","sunnypon1013@gmail.com",[49,66,82],{"facility":50,"status":30,"city":51,"state":30,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Keelung Chang Gung Memorial Hospital","Keelung","204","Taiwan","TW",{"type":56,"coordinates":57},"Point",[58,59],121.74094,25.13089,{"lat":59,"lon":58},[62,64,65],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":63},"b9005030@gmail.com",{"name":45,"role":40,"phone":46,"phoneExt":30,"email":47},{"name":36,"role":37,"phone":30,"phoneExt":30,"email":30},{"facility":67,"status":30,"city":68,"state":30,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Linkou Chang Gung Memorial Hospital","Taoyuan","333",{"type":56,"coordinates":71},[72,73],121.29696,24.99368,{"lat":73,"lon":72},[76,80,81],{"name":77,"role":40,"phone":78,"phoneExt":30,"email":79},"Hsing-Yu Chen, MD","+886-975366119","8705016@cgmh.org.tw",{"name":45,"role":40,"phone":46,"phoneExt":30,"email":47},{"name":77,"role":37,"phone":30,"phoneExt":30,"email":30},{"facility":83,"status":30,"city":68,"state":30,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Taoyuan Chang Gung Memorial Hospital",{"type":56,"coordinates":85},[72,73],{"lat":73,"lon":72},[88,89],{"name":77,"role":40,"phone":78,"phoneExt":30,"email":79},{"name":45,"role":40,"phone":46,"phoneExt":30,"email":47},{"type":37,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"YUAN-CHIEH YEH","Associate Professor \u002F Attending Physician",[94],{"name":95,"class":96},"National Science and Technology Council","FED","100647242","phase-1-safety-and-dose-response-of-bletilla-formosana-in-prediabetic-subjects-100647242",false,"NCT07704944","Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects","A Phase I\u002FII Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects","Inclusion Criteria:\n\n1. Adults aged 30-70 years.\n2. Prediabetes defined by any of the following:\n3. Fasting Plasma Glucose (FPG) of 100-125 mg\u002FdL, or\n4. Glycated hemoglobin (HbA1c) of 5.7%-6.4%.\n5. Willingness to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).\n2. Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.\n3. Abnormal renal function, defined as serum creatinine (Cr) \\>1.5 mg\u002FdL or Estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m².\n4. Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.\n5. Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.\n6. Recent use of medications (within 1 month) that may significantly alter blood glucose or lipids, such as systemic corticosteroids or non-stable doses of lipid-lowering agents.\n7. Malignant tumor under active treatment, or immunodeficiency\u002Fautoimmune disorders requiring immunosuppressive therapy.\n8. Psychiatric disorders or cognitive impairment that may affect protocol compliance.\n9. Active use of other investigational drugs within 3 months prior to screening.\n10. Pregnancy or lactation.","ALL","30 Years","70 Years",{"count":108,"type":109},94,"ESTIMATED","INTERVENTIONAL",[112,113],"PHASE1","PHASE2","This study evaluates the safety and preliminary efficacy of Bletilla formosana (BF), a traditional herbal medicine, in adults with prediabetes. Prediabetes is a high-risk condition where blood sugar levels are elevated, often leading to type 2 diabetes. While lifestyle changes are the standard treatment, researchers are exploring herbal supplements as a complementary way to support metabolic health. Preclinical research has shown that BF possesses anti-inflammatory properties and may help regulate blood glucose. Participants in this study will be randomly assigned to receive either a high dose of BF, a low dose of BF, or a placebo (an inactive substance) for 12 weeks. The total study duration is approximately 24 weeks, involving four clinic visits for blood tests and safety monitoring to see how BF affects blood sugar markers and inflammation.",[116],"Prediabetes",[116,118,119,120,121,122,123,124,125,126],"Bletilla formosana","Traditional Chinese Medicine","Herbal Medicine","Glycemic Control","Anti-inflammatory","Dose-Response Relationship","Phase I\u002FII Trial","Randomized Controlled Trial","Safety and Tolerability","NOT_YET_RECRUITING","2026-07-14",{"date":130,"type":131},"2026-07-15","ACTUAL",{"date":133,"type":109},"2026-07-01",{"date":135,"type":109},"2027-08-01",{"name":5,"class":6},3]