Diabetes Coronary Heart Disease with Damp-heat Obstruction Collateral
Conditions
Interventions
Sponsors
Affiliated Hospital of Shaanxi University of Chinese M
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for type 2 diabetes, and disease course >=6 months; Meet the diagnostic criteria of stable coronary artery disease, CCS grade >=II in the screening phase of stable angina; (3) Meet the TCM diagnostic criteria of damp-heat and collaterals blocking syndrome; (4) Aged 40-80 years, both male and female; (5) Screening period HbA1c 4.0 to 8.0%; (6) Volunteer, understand, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclusion indicators related to disease status: (1) T1DM, secondary diabetes or failure to specify which type of diabetes is the first diagnosis; (2) Those who experienced severe hypoglycemic events, experienced ketoacidosis, or hyperosmolar coma within 3 months; (3) Those who had acute coronary syndrome (ACS) within 3 months; (4) New cerebrovascular accidents within 6 months; (5) Patients with uncontrolled severe heart failure (NYHA grade >=III), severe arrhythmia and other heart diseases; 2. TCM syndrome type clinical performance exclusion indicators: (6) Patients with TCM syndromes that have obvious manifestations of cold syndrome, symptoms: fear of cold, cold limbs, urine clear long, etc.; 3. Exclusion indicators related to previous medication: (7) Those who have received other traditional Chinese medicine within 14 days before administration for the treatment of damp-heat obstruction syndrome, diabetes, or coronary heart disease; (8) Allergic constitution or previous allergy to multiple drugs, or allergic to the ingredients in the study drugs; 4. Exclusion indicators related to the health status of patients: (9) Uncontrolled hypertension, systolic blood pressure (SBP) >=180mmHg and/or diastolic blood pressure (DBP) >110 mmHg; or SBP <90 mmHg and/or DBP <50 mmHg; (10) Patients with severe liver and kidney dysfunction (including patients undergoing dialysis) and active liver disease (including primary biliary cirrhosis and unexplained persistent liver dysfunction); (11) Patients with comorbidities that may interfere the efficacy or safety assessment: such as cardiovascular, respiratory, gastrointestinal, pancreatic, pancreatic, liver, kidney, neuropsychiatric, and blood systems ( Such as hematological tumors, hemolytic anemia, sickle cell disease, etc.), immune system diseases; (12) Patients with serious systemic diseases such as malignant tumors before screening; 5. Conventional exclusion indicators: (13) Females who are pregnant or lactating, preparing for pregnancy during the trial, or have a positive pregnancy test at the time of admission; (14) Participation in other clinical studies within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCS classification of stable angina;Treadmill test (for some subjects); | — |
Secondary
| Measure | Time frame |
|---|---|
| Treadmill test (for some subjects);TCM Syndrome Points;Fasting blood glucose, glycosylated hemoglobin;Nitroglycerin usage;Lipid check;Seattle Angina Scale Score; | — |
Countries
China
Contacts
Public ContactJiehong Yang
Zhejiang University of Chinese Medicine
Outcome results
None listed