Diabetes
Conditions
Interventions
Traditional Chinese Medicine Group:Specialists provide guidance on diet, exercise, and other lifestyle aspects
Jianpi Qinghua Granules, 2 packets daily, taken orally.
Control Group:Guided by a specialist in diet, exercise, and other lifestyle aspects.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes mellitus patients (newly diagnosed with type 2 diabetes and no use of antidiabetic drugs in the past three months); 2)Traditional Chinese Medicine (TCM) conforms to the diagnosis of "Qi and Yin Deficiency Syndrome" for "diabetes" as outlined in the Guidelines for the Prevention and Treatment of Diabetes with Traditional Chinese Medicine.; 3)In the context of lifestyle interventions such as diet and exercise, 6.5% = HbA1c = 10%; 7 mmol/L = FBG = 13.0 mmol/L; 4)Age between 30 and 70 years; 5)Body Mass Index (BMI) = 24.0 kg/m²; 6)No participation in any form of drug clinical trial in the past three months prior to enrollment; 7)No severe cardiovascular, hepatic, or renal diseases; 8)Able to take Chinese herbal decoction continuously for three months and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe hepatic or renal dysfunction, mental disorders, severe infections, severe anemia, or neutropenia; 2. Severe organic heart disease or symptoms of heart failure; 3. Currently undergoing treatment with antidiabetic medications; 4. History of acute diabetic complications in the past 3 months, such as diabetic ketoacidosis or hyperosmolar hyperglycemic nonketotic coma; 5. Currently taking weight-loss medications, or use of hormonal medications within the past 3 months; 6. History of other severe internal medical conditions in the past 5 years, such as tumors, immune system diseases, or hematological diseases; 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Blood Glucose Target Range; | — |
Secondary
| Measure | Time frame |
|---|---|
| skeletal muscle content;5 times sit-to-stand test time;Daily Average Blood Glucose Level;Standard deviation of daily average blood glucose;Mean Amplitude of Glucose Variation (MAGV);blood glucose coefficient of variation;Fasting Blood Glucose;2-hour postprandial blood glucose;Fasting Insulin;glycated hemoglobin; | — |
Countries
China
Contacts
Public ContactXu Junfei
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed