Clinical Study on Yue Lingfang Intervention for Qi-Yin Deficiency with Damp-Heat in Type 2 Diabetes Mellitus

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: Experimental Group:Yue Lingfang + Reinforced Lifestyle Intervention;Control Group:Placebo + Intensive Lifestyle Intervention; CONDITION: Type 2 Diabetes PRIMARY OUTCOME: Diabetes remission maintenance rate after 12 weeks of treatment.; SECONDARY OUTCOME: glycated hemoglobin;Fasting Blood Glucose;2‐hour postprandial blood glucose;Postprandial C‐peptide;Fasting C‐peptide;Insulin;Body Mass Index;waist;Waist‐Hip Ratio;Waist‐to‐Height Ratio;Triglyceride;High‐Density Lipoprotein;Low‐Density Lipoprotein;Total Cholesterol;free fatty acids;Traditional Chinese Medicine (TCM) Syndrome Efficacy Scoring;Diabetes‐specific quality of life scale;tumor necrosis factor‐alpha;Interleukin‐6;High‐Sensitivity C‐Reactive Protein;Adiponectin;Skin Microcirculatory Perfusion;Transcutaneous oxygen tension; INCLUSION CRITERIA: 1. Age = 18 years and = 65 years, gender; 2. Meet the diagnostic criteria for type 2 diabetes mellitus in Western medicine; 3. Meet the criteria for deficiency of both qi and yin with damp‐heat syndrome in Traditional Chinese Medicine; 4. Duration of illness = 5 years; 5. Meet the criteria for 24 kg/m² = BMI = 32.5 kg/m² (or waist circumference: >90 cm for males, >85 cm for females); 6. Fasting C‐peptide = 1.1 µg/L; 7. Negative for GADA and other antibodies related to type 1 diabetes; 8. After previous individualized blood glucose control, blood glucose control is achieved, defined as: HbA1c < 6.5% or FPG < 7 mmol/L; (Allowed previous blood glucose control treatments: No drug treatment: blood glucose control through diet and exercise only, meeting blood glucose control standards; Drug treatment: metformin, a‐glucosidase inhibitors, SGLT2 inhibitors, insulin, mulberry branch total bioalkali (two or fewer)); 9. The subject understands,
Epistemonikos ID: b3cde1a5a83bad5b64681dca0b64f8036a5c5416
First added on: Aug 10, 2026