Type 2 Diabetes
Conditions
Interventions
Experimental Group:Subjects orally take the Astragalus Sour Plum Decoction provided uniformly by researchers daily at 14:00, consumed immediately after mixing. Continuous intervention for 30 days.
Control Group:Subjects consume placebo decoction identical in appearance, odor, and preparation method to the intervention group's Astragalus Sour Plum Decoction at 14:00 daily. Placebo provided unifo
Sponsors
Hongguang Community Health Service Center, Pidu District, Chengdu City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fasting plasma glucose (FPG) =7.0 mmol/L (fasting defined as no caloric intake for at least 8 hours); 2-hour postprandial glucose (2hPG) during oral glucose tolerance test (OGTT) =11.1 mmol/L; Glycated hemoglobin HbA1c =6.5%; Typical diabetes symptoms (polydipsia, polyphagia, polyuria, weight loss) + random plasma glucose =11.1 mmol/L (Diagnosis of diabetes can be made if any one or more of the above four criteria are met. Participants aged 18-75 years with 18.5 = BMI =35 are eligible, prioritizing those with BMI =24. Exclusions: Low BMI: Generally exclude participants with BMI <18.5 kg/m² as low weight may indicate malnutrition, underlying consumptive diseases, or atypical diabetes subtypes (e.g., early-stage LADA may present with leanness). Extreme BMI: Upper limit (e.g., 35 kg/m²) avoids severe obesity-related complications (e.g., severe sleep apnea, refractory hypertension) becoming dominant factors affecting drug efficacy/safety.) Note: Participants with controlled blood glucose are eligible. Diagnostic criteria follow the 2024 Chinese Diabetes Prevention and Treatment Guidelines. 2. Voluntary participation with signed ethics-approved informed consent. 3. Ability to complete full trial follow-up. 4. No antibiotic/probiotic use within 4 weeks prior to trial. 5. Dyslipidemia with fluctuations is generally acceptable but requires specific lipid parameter limits: Triglycerides =5.6 mmol/L indicates severe hypertriglyceridemia (acute pancreatitis risk); LDL-C =4.9 mmol/L indicates severe hypercholesterolemia. Note: Criteria follow 2024 Chinese Lipid Management Guidelines (Primary Care Edition). Total cholesterol =6.2 mmol/L indicates hypercholesterolemia. Reference: Chinese Adult Dyslipidemia Prevention Guidelines. Normal adult total cholesterol: 2.8-5.2 mmol/L. Fasting triglycerides: 0.56-1.70 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Latent Autoimmune Diabetes in Adults (LADA patients) 2. Severe diabetic complications such as diabetic nephropathy (e.g., severe renal insufficiency (eGFR 10 mg/day), immunosuppressants, antipsychotics (e.g., olanzapine), GLP-1 receptor agonists, SGLT2 inhibitors, etc. (adjusted according to trial drug mechanism)), history of substance abuse (past 1 year, e.g., alcohol) with minimum 4-week washout period 5. Mental illness or cognitive impairment (unable to understand trial procedures or cooperate with follow-up) 6. Expected survival <1 year 7. Advanced malignancies 8. Participation in other clinical trials within past 3 months 9. Major surgery within past 3 months 10. Active infectious diseases 11. Medication interference: (1) Allergy or intolerance to HQSM: Including but not limited to any of: Astragalus, Hawthorn, Sea Buckthorn, Dried Tangerine Peel, Dark Plum, Lily Bulb, Licorice Root, or previous use of similar herbal preparations without adverse reactions (2) Allergy or intolerance to metformin Note: Any patient meeting the above criteria will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Insulin;glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Height;Cholesterol;Triglyceride;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;free fatty acids;IL-4;IL-6;Transforming Growth Factor-ß;Tumor Necrosis Factor-alpha;Inducible Nitric Oxide Synthase;Superoxide Dismutase;malondialdehyde;Alanine Aminotransferase;Serum glutamic-oxaloacetic transaminase;Gut microbiota a-diversity;Gut microbiota ß-diversity;Differential abundance analysis;Functional pathway prediction; | — |
Countries
China
Contacts
Public ContactMa Xiaoju
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed