ITMCTR2000003818尚未招募4 期
Study on the evolution and clinical characteristics of damp-heat syndrome in diabetic coronary heart disease
Affiliated Hospital of Shaanxi University of Chinese M0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •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.
研究者
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