ITMCTR2000003818
Not yet recruiting
Phase 4
Study on the evolution and clinical characteristics of damp-heat syndrome in diabetic coronary heart disease
Affiliated Hospital of Shaanxi University of Chinese M0 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Affiliated Hospital of Shaanxi University of Chinese M
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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