Type 2 diabetes
Conditions
Interventions
Experimental group:Sangzhi Total Alkaloids Tablets (50mg), take 1 tablet each time, 3 times a day, chew and swallow with the first bite of the main meal. The dosage can be adjusted by the clinician ba
Control group:Medication is to be taken at the regular dosage as prescribed by the doctor, including metformin, sulfonylureas, glinides, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibi
Sponsors
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent form, age>=40 years, gender is not limited; 2. Confirmed diagnosis of type 2 diabetes mellitus according to WHO diagnostic criteria; 3.7%=140 mmHg and/or diastolic blood pressure>=90mmHg, or/and/or those who are currently taking antihypertensive drugs to control blood pressure; (2) Dyslipidemia: total cholesterol (TC) > = 5.2 mmol/L and/or low-density lipoprotein cholesterol (LDL-C) > = 3.4 mmoL/L and/or high-density lipoprotein cholesterol (HDL-C) =28kg/m^2; (4) Smokers: According to the 1997 WHO definition: smokers are smokers who smoke continuously or cumulatively for 6 months or more in their lifetime; (5) CKD3a stage: 45<=eGFR<60mL/min/1.73m^2); Able to understand the procedures and methods of this clinical trial, with full informed consent, the patient voluntarily participates and the informed consent form is signed by the patient himself or a guardian or fair witness.
Exclusion criteria
Exclusion criteria: 1. Allergy or intolerance to the drugs used; 2. Ketoacidosis, diabetic lactic acidosis or hyperosmolar non-ketotic coma in the past 6 months, requiring hospitalization; 3. Severe hypoglycemia events of unknown cause in the past 6 months (need help from others to recover); or frequent hypoglycemia: such as more than 2 hypoglycemic events (blood glucose 3×ULN or TBil>2×ULN; 5. Patients with kidney disease: glomerular filtration rate 1.5×ULN; 6. Fasting C-peptide =160mmHg or DBP>=100mmHg; 8. Patients with severe acute complications of DM, such as diabetic ketoacidosis, diabetic hyperosmolar coma, lactic acidosis, etc.; 9. Patients with severe chronic complications of DM, such as diabetic foot, severe diabetic nephropathy, severe neurological diseases, severe retinal diseases, etc.; 10. Diseases that may cause hemolysis or erythrocyte instability that affect HbA1c detection, such as hemoglobinopathies (such as sickle cell anemia or thalassemia, sideroblastic anemia); 11. Patients with conditions that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal postoperative and intestinal ulcers); 12. Infection, active inflammation; 13. Delirium, dementia, mental illness; 14. Alcoholism, suspected or definite history of drug abuse; 15. Participated in clinical trials of other scientific research drugs or medical devices within 1 month before signing the informed consent form, and received treatment with investigational drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c;Fasting blood glucose;C-peptide;Cardiac enzymes;Liver function;Renal function;Blood lipid six items;Urine Albumin-to-Creatinine Ratio, UACR;Color Doppler echocardiography; | — |
Countries
China
Contacts
Public ContactChen Wenhui
Department of Endocrinology, The First Affiliated Hospital of Guangxi University of Chinese Medicine
Outcome results
None listed