[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641226":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":53,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy and Hua Yu Wan Capsule","EXPERIMENTAL","1． Standard Baseline Medication: Hua Yu Wan Capsule: 5g, taken orally two times daily. Treatment Duration: The combined regimen is administered continuously for 6 months (divided into four 6-week cycles).\n\n2\\. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments without receiving the study drug.",[13,14],"Drug: Hua Yu Wan Capsule","Drug: Aspirin",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Therapy Alone","ACTIVE_COMPARATOR","1. Standard Baseline Medication:\n\n   Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 6 months.\n2. Follow-up: After the 6-month treatment period, participants enter a 12-month follow-up phase for observational assessments.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Hua Yu Wan Capsule","A modern preparation of the classic Traditional Chinese Medicine formula Bu Yang Huanwu Decoction. Each capsule contains 0.2g of the herbal extract.\n\nDosage and Route: 2 capsules, taken orally three times daily.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Aspirin","Aspirin: 100 mg, administered orally once daily. Treatment Duration: The standard medication is administered continuously for 12 months.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"JIANMING GUO, M.D.","CONTACT","+86 13146369562","guojianming@aliyun.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Xuanwu Hospital","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[54,56,58],{"name":55,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine",{"name":57,"class":6},"Dongzhimen Hospital, Beijing",{"name":59,"class":6},"Peking University Third Hospital","100641226","phase-3-evaluating-bu-yang-huanwu-decoction-for-early-diabetic-vascular-disease-100641226",false,"NCT07658807","Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease","Evidence-Based Evaluation and New Drug Translation Research of Early Intervention With the Classic Traditional Chinese Medicine Formula Bu Yang Huanwu Decoction for Preventing and Treating Diabetic Lower Extremity Vascular Disease","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive), male or female.\n2. Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.\n3. Glycated hemoglobin (HbA1c) \\\u003C 12%, with recent fasting blood glucose \\\u003C 7.0 mmol\u002FL OR postprandial blood glucose \\\u003C 10.0 mmol\u002FL, and triglycerides \\\u003C 1.7 mmol\u002FL.\n4. Diagnosed with LEAD, meeting the following criteria:\n\n   Rutherford Classification 2, 3, or 4.\n\n   Resting ABI ≤ 0.90, OR for patients with exertional symptoms and resting ABI \\> 0.90, a post-exercise treadmill test showing an ABI decrease of ≥15%.\n\n   Evidence of lower limb arterial stenosis or occlusion confirmed by duplex ultrasound, CTA, MRA, or DSA.\n5. TCM Pattern Diagnosis: Must conform to the TCM syndrome of Qi Deficiency and Blood Stasis, as defined by the study's TCM diagnostic criteria (referencing \"Practical Diagnostic Criteria for Blood Stasis Syndrome\" and \"Integrated Chinese and Western Medicine Peripheral Vascular Disease\"):\n\n   Main Symptom: Lower limb weakness, or feeling of heaviness\u002Fdiscomfort after prolonged walking.\n\n   Secondary Symptoms: Shortness of breath\u002Flassitude in speaking; dry mouth with desire to drink; scaly skin.\n\n   Tongue \\& Pulse: Tongue with teeth marks, pale-purple with petechiae\u002Fecchymosis; thin and choppy pulse.\n\n   (Diagnosis confirmed by meeting 1 main symptom OR 2 secondary symptoms, assessed by a qualified TCM practitioner.)\n6. Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Known bleeding disorders or history of intracranial hemorrhage.\n2. Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).\n3. Presence of active infection.\n4. Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).\n5. History of acute coronary syndrome ≤ 12 months requiring dual antiplatelet therapy.\n6. Chronic liver disease (Child-Turcote-Pugh score ≥5) or chronic kidney disease stages 4-5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n7. History of malignancy (except cured basal cell carcinoma).\n8. Moderate to severe anemia, polycythemia vera, or any hyperviscosity syndrome.\n9. Planned lower limb revascularization or amputation.\n10. Concurrent or planned use of medicinal products containing Veratrum species.\n11. Pregnant or lactating women, or women of childbearing potential not using highly effective contraception.\n12. Known allergy or hypersensitivity to any component of the study medication (Qilong Capsules, aspirin).\n13. Patients with psychiatric disorders or judged to be uncooperative.\n14. Currently participating in another drug clinical trial or using therapies with similar purported effects.\n15. Any other condition deemed by the investigator to make the participant unsuitable for the trial.","ALL","18 Years","70 Years",{"count":71,"type":72},300,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are:\n\nDoes adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone?\n\nIs the treatment combination safe for participants?\n\nResearchers will compare two groups:\n\nGroup 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.\n\nGroup 2 (Control): Standard treatment alone.\n\nParticipants in this study will:\n\nBe adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI).\n\nBe randomly assigned to one of the two treatment groups.\n\nTake their assigned treatment for 6 months.\n\nAttend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.",[78,79,80],"Peripheral Arterial Disease","Diabetic Angiopathies","Arterial Occlusive Diseases",[78,82,83,84],"Ischemia","Medicine, Chinese Traditional","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-15",{"date":88,"type":89},"2026-06-22","ACTUAL",{"date":91,"type":72},"2026-06",{"date":93,"type":72},"2029-01",{"name":5,"class":6},1]