Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Type 2 diabetes patients who meet the Western medicine diagnostic criteria for diabetes; (2) Patients with spleen deficiency of traditional Chinese medicine; (3) Poor control: blood glucose [7.0 mmol/L FPG (venous blood) 10.0mmol/L;7.0% <HbA 1 c (HbA 1 c) 9.0%]; (4) Age is 30 ~60 years old (including both ends), gender is not limited; (5) The subject was informed and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with type 1 diabetes, gestational diabetes, type 2 diabetes and other special types of diabetes that need insulin therapy; (2) Patients with acute complications of diabetes mellitus; (3) Severe cardiac and cerebrovascular diseasesand serious primary diseases, such as liver, kidney and hematopoietic system; (4) People with known allergies and allergic constitution to the study drug; (5) Pregnant and lactating women and women with recent familyplanning; (6) Long-term alcoholism, drug dependence, and patients with mental illness; (7) Those who have participated in or are participating in other drug clinical trials within one month before the screening period of the study; (8) Theinvestigator is not inappropriate to attend the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose and 2-h postprandial blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal flora in stool;Bile acid in stool;Short chain fatty acid;fasting insulin (FINS),;TCM Syndrome Integral Scale;Glycosylated serum protein;(A - DQOL); | — |
Countries
China
Contacts
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine