The safety and efficacy of Tongmai Jiangtang Capsule in the treatment of diabetic coronary heart disease with damp-heat and collaterals blocking syndrome: a randomized, double-blind, parallel-controlled, multicenter clinical trial.

Phase 4

• Conditions: Diabetes Coronary Heart Disease with Damp-heat Obstruction Collateral

• Registration Number: ITMCTR2000003818
• Lead Sponsor: Affiliated Hospital of Shaanxi University of Chinese M

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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;
(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treadmill test (for some subjects);CCS classification of stable angina;

Secondary Outcome Measures

Name	Time	Method
ipid check;Fasting blood glucose, glycosylated hemoglobin;TCM Syndrome Points;Treadmill test (for some subjects);Nitroglycerin usage;Seattle Angina Scale Score;