protocolSection identificationModule nctId: NCT06358118, orgStudyIdInfo id: 2024-003-KY, briefTitle: Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Qing Ni, class: OTHER, descriptionModule briefSummary: The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.The main questions it aims to answer are:1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.Participants will:1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;4. Urine and serum samples were collected before and after treatment;, conditionsModule conditions: Diabete Mellitus, conditions: Aging, conditions: Metabolic Disorders, conditions: Traditional Chinese Medicine, conditions: Randomized Controlled Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Buyuan Zhixiao Formula, interventions name: Placebo, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Fasting blood glucose, secondaryOutcomes measure: 2-hour postprandial blood glucose, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: weight, secondaryOutcomes measure: waist circumference, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Total Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: High density lipoprotein cholesterol, secondaryOutcomes measure: Low density lipoprotein cholesterol, secondaryOutcomes measure: Ankle-Brachial Index（ABI）, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: C-peptide, secondaryOutcomes measure: insulin resistance index, secondaryOutcomes measure: islet β-cell function index, secondaryOutcomes measure: lipid Lipid accumulation product, secondaryOutcomes measure: visceral adiposity index, secondaryOutcomes measure: Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points, secondaryOutcomes measure: Concentration Variation of Interleukin-10, secondaryOutcomes measure: Change in Homocysteine Levels, secondaryOutcomes measure: Average Concentration of Interleukin-6, secondaryOutcomes measure: Change in Endothelin-1 Levels, secondaryOutcomes measure: Average Concentration of Nitric Oxide, secondaryOutcomes measure: Concentration Variation of Von Willebrand Factor, secondaryOutcomes measure: Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points, secondaryOutcomes measure: Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration, secondaryOutcomes measure: Average Concentration of Soluble Intercellular Adhesion Molecule-1, secondaryOutcomes measure: Change in Serum Tau Protein Levels, secondaryOutcomes measure: Average Concentration of Aβ40, secondaryOutcomes measure: Average Concentration of Aβ42, secondaryOutcomes measure: Change in Neurofilament Light Chain Protein Levels, secondaryOutcomes measure: Carotid Ultrasound; Carotid Intima-Media Thickness., secondaryOutcomes measure: Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score., secondaryOutcomes measure: Montreal Cognitive Assessment Score, secondaryOutcomes measure: Fried Frailty Phenotype Scale, secondaryOutcomes measure: Activities of Daily Living Scale score, secondaryOutcomes measure: Mini Nutritional Rating Scale, secondaryOutcomes measure: Serum and urine metabolomics, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital, city: Beijin, state: Beijing, zip: 100053, country: China, contacts name: Qing Ni, postgraduate, role: CONTACT, phone: 010-88001245, email: 1831479145@qq.com, contacts name: zhige Wen, postgraduate, role: CONTACT, phone: 15890643963, email: 1831479145@qq.com, locations facility: Cangzhou integrative medicine hospital, city: Hebei, country: China, contacts name: zhongyong zhang, postgraduate, role: CONTACT, phone: 18031783396, email: zzyhappy666@126.com, locations facility: Hohhot Mongolian Traditional Chinese Medicine Hospital, city: Neimeng, country: China, locations facility: Binzhou Traditional Chinese Medicine Hospital, city: Shandong, country: China, contacts name: lijuan Du, postgraduate, role: CONTACT, phone: 18800102622, email: 137425497@qq.com, locations facility: Yantai Baishi Traditional Chinese Medicine Hospital, city: Shandong, country: China, locations facility: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, city: Tianjin, country: China, contacts name: bin Wang, postgraduate, role: CONTACT, phone: 13051395068, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False