type 2 diabetes
Conditions
Interventions
Sancai group:Control of blood glucose with Sancai Lianfang oral traditional Chinese medicine formulation
acarbose group:Control of blood glucose with Acarbose oral medication
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medicine diagnostic criteria and traditional Chinese medicine syndrome differentiation criteria for this study: ? Western medicine diagnostic criteria: Refer to the "China 2 Diabetes Prevention and Treatment Guidelines" (2020 edition) diabetes diagnostic criteria: Typical diabetes symptoms (polydipsia, polyuria, polyphagia, unexplained weight loss), and meet one of the following conditions, can be diagnosed as diabetes: Random venous blood glucose =11.1 mmol/L; Fasting venous blood glucose =7.0 mmol/L; 2-hour venous blood glucose after glucose load =11.1 mmol/L. ? Traditional Chinese medicine syndrome differentiation criteria: According to the "Clinical Evidence-based Practice Guidelines for Traditional Chinese Medicine in Diabetes" (2016 edition) and the "Clinical Diagnosis and Treatment Guidelines for Traditional Chinese Medicine Diabetes" (2022 edition), the criteria for differentiating diabetes with yin deficiency and internal heat are formulated as follows: Yin deficiency and internal heat type Main symptoms: Dry throat, restlessness and irritability. Accompanying symptoms: Increased hunger and food intake, dry mouth and thirst, preference for cold drinks, increased water intake, frequent and abundant urination, spontaneous sweating or night sweats, insomnia and vivid dreams, short and red urine, dry stools. Tongue appearance: Red tongue with scanty coating or without coating. Pulse condition: Thready and rapid pulse or large and hollow pulse. Diagnosis can be made if the main symptoms are present, combined with two or more accompanying symptoms, or if the tongue appearance and pulse condition are consistent. (2) Age 18-75, newly diagnosed type 2 diabetes patients (HbA1c: 7.0%-9.5%; fasting plasma glucose [FPG]: 7.0-11.1 mmol/L), disease duration 90 cm for men and > 85 cm for women); (4) Fasting C-peptide = 1.1 µg/L, postprandial 2-hour C-peptide = 2.5 µg/L; (5) Negative pregnancy test and agreement to use reliable contraception methods (in all women of childbearing potential); (6) Ability to self-monitor capillary blood glucose; (7) Willing to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with type 1 diabetes; patients with adult latent autoimmune diabetes, malignant tumors, or other autoimmune diseases. (2) Currently receiving insulin treatment. (3) Patients with severe acute or chronic complications of diabetes. (4) Patients with endocrine disorders such as pituitary, thyroid, and adrenal diseases. (5) Patients with severe primary diseases involving multiple organs or systems that are life-threatening or with mental illness. (6) Patients with severe trauma, infection, or in the perioperative period. (7) Patients with severe gastrointestinal diseases, including colorectal cancer, irritable bowel syndrome, inflammatory bowel disease, chronic or acute diarrhea, or chronic constipation. (8) Patients who have undergone gastrointestinal or abdominal surgery within one year. (9) Patients prone to intestinal obstruction or any diseases requiring systemic glucocorticoid treatment. (10) Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =95 mmHg). (11) Pregnant, lactating women, or those planning to conceive during the trial period. (12) Patients with severe heart disease, New York Heart Association functional class =3. (13) Patients with impaired liver function (alanine aminotransferase [ALT] > 2 times the upper limit) or impaired renal function (serum creatinine =133 µmol/L [1.5 mg/dL]). (14) Patients with allergies or allergic reactions to the drugs used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting blood glucose;Hemoglobin A1c;Fasting serum lisulin;Fasting C-peptide;oral glucose tolerance test; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete blood count;liver function;renal function;electrocardiogram;urinalysis;fecal analysis; | — |
Countries
China
Contacts
Public ContactChen Qiu
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed