type 2 diabetes mellitus
Conditions
Interventions
Experimental group:Jiang Tang Xiao Ke formula + metformin
Control group:Jiang Tang Xiao Ke formula placebo + metformin
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with newly diagnosed type 2 diabetes mellitus who have not received prior medication or patients with type 2 diabetes mellitus who have been treated with metformin only; (2) Meet the traditional Chinese medicine diagnostic criteria for both qi and yin deficiency accompanied by heat and blood stasis syndrome; (3) Glycated hemoglobin be or more than 7.0%; (4) fasting plasma glucose (FPG) < 13.9 mmol/L or 2-hour postprandial plasma glucose (2h-PG) < 18 mmol/L; (5) The age of 20 to 65 years old. Any race gender is not limited; (6) Body mass index (BMI)= 18.5 kg/m2; (7) Sign an informed consent form and voluntarily participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1)Acute diabetic complications including diabetic ketosis diabetic ketoacidosis and severe infections; 2)Severe chronic diabetic complications; 3)Serum alanine aminotransferase and aspartate aminotransferase > 3 times the upper limit of normal; abnormal serum creatinine or serum urea nitrogen; 4)Patients with severe cardiac hepatic renal cerebral or hematologic complications or with other serious primary diseases; 5)Patients with serious mental health conditions or other uncontrolled systemic diseases; 6)Patients currently or one month ago receiving another experimental drug; 7)Patients with known or suspected hypersensitivity to the study drug; 8)Women who are pregnant or planning a pregnancy; women who are breastfeeding; 9)Patients who have suffered from intestinal diseases such as severe diarrhea irritable bowel syndrome etc. in the last 3 months taking antibiotics glucocorticoids probiotics etc. that affect the intestinal microbiota; patients who have taken yogurt in the last 1 week; 10)Patients with a history of gastrointestinal and cholecystectomy surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose;2 hours postprandial glucose;Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting insulin;Waist circumference;Body mass index;Triglyceride;Low density lipoprotein cholesterol;Traditional Chinese medicine syndrome score;SF-36 Quality of Life Scale;High density lipoprotein cholesterol;Total cholesterol;Fasting C-peptide; | — |
Countries
China
Contacts
Public ContactYanbing Gong
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed