Diabetes
Conditions
Interventions
Experimental Group:In addition to conventional treatment, the participants received the Eight Pieces of Brocade combined with Coptis and ginseng granules orally. The intervention lasted for 12 weeks,
Control Group:In addition to conventional treatment, administer Eight Pieces of Brocade combined with Coptis and ginseng placebo orally. The intervention lasts for 12 weeks, with medication dispensed
Sponsors
Beijing First Integrated Traditional Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for type 2 diabetes mellitus, in accordance with the diagnostic standards for diabetes in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition). 2.TCM diagnosis: Diagnoses of dampness-heat syndrome and qi deficiency syndrome are based on the Diagnostic Criteria for Root Deficiency and Branch Excess Syndromes of Diabetes and Its Complications, reviewed and adopted by the Council of the Diabetes Professional Committee of the World Federation of Chinese Medicine Societies in 2016. Dampness-heat syndrome 1) Dizziness and heaviness of the head, soreness and fatigue of the waist and legs, heaviness of the limbs, stuffiness and fullness of the epigastrium and abdomen, distension, or nausea and poor appetite. 2) Sticky and greasy taste in the mouth, or sweet taste in the mouth. 3) Sticky and unsmooth defecation, dark yellow and painful urination, or excessive and malodorous leukorrhea in women. 4) Red tongue with yellow and greasy coating. 5) Soft and rolling pulse, or rapid and rolling pulse. The diagnosis can be made if any 2 items from 1)2)3), or any 1 item from 1)2)3) plus 1 item from 4)5) are present. Qi deficiency syndrome 1) Lassitude and fatigue. 2) Shortness of breath, which is aggravated by movement. 3) Spontaneous sweating and susceptibility to external pathogens. 4) Anorexia, abdominal distension, or loose stools. 5) Enlarged tongue body. 6) Weak pulse. The diagnosis can be made if any 1 item from 1)2)3)4) plus any 1 item from 5)6) are present. 3.HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) = 2.69; 4.Age between 18 and 75 years old; 5.Fasting blood glucose < 7 mmol/L and postprandial blood glucose < 10 mmol/L at baseline; 6.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiovascular and cerebrovascular diseases who are unable to move; 2. Patients with chronic kidney dysfunction (eGFR < 60 ml/min); 3. Patients who refuse to participate in the survey follow-up; 4. Patients allergic to Chinese herbal formula granules or the drugs of Coptis, Ginseng, or their main components, or patients with allergic constitutions; 5. Patients with a history or evidence of any of the following diseases before screening: type 1 diabetes, monogenic mutation diabetes, diabetes caused by pancreatic damage, or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly; 6. Patients with inflammatory bowel diseases such as ulcerative colitis or Crohn's disease; 7. Patients with mental illness, or those who are pregnant, planning to become pregnant, or currently breastfeeding; All patients meeting any of the above criteria must be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Resistance Index Homeostasis Model Assessment of Insulin Resistance;Homeostasis Model Assessment of ß-cell function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index;Glycated Hemoglobin; Fasting Plasma Glucose;Waist-to-Hip Ratio; | — |
Countries
China
Contacts
Public ContactDong Chao
Beijing First Integrated Traditional Chinese and Western Medicine Hospital
Outcome results
None listed