type 2 diabetes
Conditions
Interventions
Treatment group:Lifestyle intervention+ Linggui Zhugan decoction granules
Control group:Lifestyle intervention+ Simulator of Lingguizhugan decoction granules
Sponsors
Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in the clinical trial and sign the informed consent; 2. Aged between 18 and 70 years, no gender limit; 3. In line with Western medicine type 2 diabetes (using the diagnostic and typing standards of DM in Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2017 Edition)); 4. It conforms to the syndrome differentiation standards of phlegm-dampness syndrome of traditional Chinese Medicine (refer to Internal Medicine of Traditional Chinese Medicine and Guide to Diagnosis and Treatment of Syndrome Combination of Type 2 Diabetes); 5. When randomly enrolled, 7.0%<= HbAlc <9.0%, 7.0mmolL< fasting blood glucose <11.1mmol/L or 11.1mmol/L <= 2 hours postprandial blood glucose <16.7mmol/L.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergic reaction or severe adverse reaction to the test drug; 2. Patients who received systemic glucocorticoid, growth hormone treatment for more than 7 days in the first 8 weeks; 3. Patients with diabetic ketoacidosis, hyperosmic hyperglycemia (HHS), lactic acidosis and other acute complications of diabetes within 6 months before screening; 4. Severe or frequent hypoglycemic events (including severe hypoglycemia, symptomatic hypoglycemia and asymptomatic hypoglycemia) in the 6 months before screening; (1) Severe hypoglycemia: patients need help to obtain carbohydrates, glucagon, or other rescue measures. Hypoglycemic episodes may be accompanied by neurohypoglycemic symptoms, which in severe cases induce epileptiform convulsions or coma; (2) Symptomatic hypoglycemia: typical hypoglycemic symptoms with blood glucose concentration = 2 times the upper limit of normal, serum creatinine > the upper limit of normal); 12. Complicated with autoimmune diseases, malignant tumors, and severe diseases of respiratory system, blood and hematopoietic system; 13. Patients with suspected or confirmed tendencies towards alcohol, drug abuse or dependence; 14. Pregnant or lactating patients or those who planned to have children recently (during the study period or within 6 months after the study ended); 15. Other situations that the researchers consider inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBA1c;Insulin resistance index, HOMA-IR;Blood sugar 2 hours after meal, PBG 2h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose, FBG;Waist circumference, WC;Abdominal circumference, AC;Body weight, Wt;Body mass index, BMI;Total cholesterol, TC;Triglyceride, TG;Low density lipoprotein cholesterol, LDL-C;Insulin sensitivity index, HOMA-IS;Insulin secretion index, HOMA-ß;Quantitative insulin sensitivity test index, QUICKI;Fasting insulin, INS;TCM syndrome points; | — |
Countries
China
Contacts
Public ContactCao Lin
Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed