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Clinical Trials/ITMCTR2000003818
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
Affiliated Hospital of Shaanxi University of Chinese M

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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