diabetes mellitus
Conditions
Interventions
low dose group:On the basis of basic treatment, low-dose Yunujian granules were given 1 bag each time, 2 times a day. Metformin tablet: Oral 0.5 g/time, 3 times/d.
high dose group:On the basis of basic treatment, high-dose Yunvjian granules were given 1 bag each time, 2 times a day. Metformin tablet: Oral 0.5 g/time, 3 times/d.
placebo group:On the basis of basic treatment, placebo granules were given 1 bag each time, 2 times a day. Metformin tablet: Oral 0.5 g/time, 3 times/d.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Newly diagnosed patients who meet the diagnostic criteria of T2DM with T2DM and Yin deficiency syndrome, and who have not received drug treatment before or who have only received first-line hypoglycemic drug (metformin hydrochloride) treatment; (2) Glycated hemoglobin=7.0%, FBG18.0 kg/m2; (5) Sign the informed consent form and voluntarily participate in this experiment. Included patients must meet all the above conditions, any one is "No", this subject cannot participate in the trial.
Exclusion criteria
Exclusion criteria: (1) Acute diabetic complications, including diabetic ketosis, diabetic ketoacidosis, and serious infections; (2) Severe chronic diabetes complications; (3) Serum alanine aminotransferase, aspartate aminotransferase > 3 times the upper limit of normal, abnormal serum creatinine or serum urea nitrogen; (4) Patients with severe heart, liver, kidney, brain, blood system and other complications or combined with other serious primary diseases; (5) Have serious mental health conditions or other uncontrollable systemic diseases; (6) Patients currently or one month ago receiving another experimental drug; (7) Known or suspected allergy to the study drug; (8) Women who are pregnant or planning to become pregnant, and lactating women; (9) Continuous use of antibiotics in the past 3 months, and the course of treatment exceeds 3 days; (10) The patient has taken probiotics/prebiotics or other microecological regulators in the past 3 months. If any of the above is "yes", the subject cannot participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2hPG;FPG;HbAlc; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Fasting insulin level and C-peptide detection;blood lipids; | — |
Countries
China
Contacts
Public ContactWeijunping
Outcome results
None listed