Type 2 diabetes
Conditions
Interventions
Experimental Group vs Control Group:Shenlian Xiaoke Formula granules + Standard care VS Shenlian Xiaoke Formula Placebo + Standard care
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for type 2 diabetes and Qi Deficiency with Internal Heat syndrome in Traditional Chinese Medicine; (2) Glycated hemoglobin (HbA1c) = 10%; (3) Age between 18 and 75 years (inclusive), any gender; (4) Willing and able to perform self-monitoring of blood glucose as required by the protocol; (5) Provides voluntary written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with severe comorbidities of the heart, liver, kidney, hematopoietic system, or malignancies; (2) Severe hypertension uncontrolled by medication (defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg); (3) Uncontrolled conditions such as active infection or severe electrolyte disturbances; (4) Known allergy to any component of the investigational formula granules (Coptis, Ginseng) or the placebo; (5) History of severe mental illness; (6) Pregnant or lactating women; (7) Participation in other clinical trials that may interfere with this study's outcomes within the preceding 3 months; (8) Considered by the investigator to be unsuitable for trial participation (e.g. high risk of loss to follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time In Range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting C-peptide;Serum Metabolites;HOMA-IR;Gut Microbiota;Fasting blood glucose;Urinary Metabolites;Blood lipid;HOMA-ß;TCM Syndrome Score ;Body mass index;2-hour Postprandial Blood Glucose;Standard Deviation of Blood Glucose; | — |
Countries
China
Contacts
Public ContactWANG Shidong
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed