Type 2 Diabetes
Conditions
Interventions
Basic Treatment Group:Basic diet, exercise guidance + Metformin extended-release tablets.
Traditional Chinese Medicine Treatment Group:Basic dietary and exercise guidance + Metformin Extended-Release Tablets + Qingjiang Formula
Sponsors
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. In accordance with the "Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)" issued by the Diabetes Branch of the Chinese Medical Association, subjects who meet the Western medical diagnostic criteria for type 2 diabetes mellitus; 2. Age between 18 and 70 years (inclusive); 3. Duration of diabetes between 2 and 6 years (inclusive); 4. Subjects who have not used antidiabetic medications or are using only one type of antidiabetic medication; 5. Glycated hemoglobin (HbA1c) between 6.5% and 9% (inclusive); 6. In accordance with the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes in Traditional Chinese Medicine (2024 Edition)" and the "Chinese Guidelines for the Integrated Traditional and Western Medicine Diagnosis and Treatment of Type 2 Diabetes (2024 Edition)," subjects who meet the diagnostic criteria for the TCM syndrome of "dampness obstruction and fire depression": - Principal symptoms: chest oppression, epigastric, generalized heaviness and fatigue, heat in the palms, soles, and chest, and body heat that is not easily dissipated; - Secondary symptoms: dizziness, excessive sleepiness, halitosis, sticky sensation in the mouth, irritability, bitter taste in the mouth, preference for cold drinks, obesity, poor appetite, abdominal distension, sticky or foul-smelling stools, and yellow or turbid urine; - Tongue appearance: swollen tongue or teeth marks on the sides, yellow and greasy coating; - Pulse appearance: slippery and rapid or soft and rapid; - The principal symptoms must be present, at least one secondary symptom must be present, and the diagnosis must be confirmed by a panel of two TCM associate chief physicians or above with experience in diabetes diagnosis and treatment, based on the tongue and pulse findings. 7. Subjects who voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of diabetic ketoacidosis, hyperglycemic hyperosmolar state, or other acute metabolic disorders of diabetes within the past 3 months, or presence of severe stress state; 2. Intolerance to metformin; 3. Severe liver dysfunction (alanine aminotransferase or aspartate aminotransferase more than 2.5 times the upper limit of normal) or renal dysfunction (serum creatinine above the upper limit of normal or glomerular filtration rate =60 ml/min/1.73m²); 4. Severe heart failure (ejection fraction <30% or NYHA class III or IV); 5. Severe uncontrolled hypertension, with systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg at screening; 6. Unable to cooperate to complete the study due to visual or physical impairments; 7. Malignant tumors, severe psychosomatic diseases, or severe illnesses with life expectancy not exceeding 2 years; 8. History of receiving hormones, immunosuppressants, or cytotoxic therapy within the past 3 months; 9. Women who are pregnant, breastfeeding, or planning to conceive; 10. History of alcohol abuse or substance addiction; 11. Allergy to components of the investigational drug; 12. Poor expected compliance, unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Indices (Complete Blood Count + Liver and Kidney Function);Urine Parameters;Stool + Occult Blood Test;TCM Syndrome Score;Vital signs;Lifestyle;Quality of Life Scale Assessment;Endpoint Events; | — |
Countries
China
Contacts
Public ContactGao hong
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed