ITMCTR2000002928
Not yet recruiting
Phase 1
Clinical study for the effect of Combinative Treatment of Heart and Spleen on intestinal flora in patients with non-st-segment elevation myocardial infarction with qi deficiency and blood stas
Conditionsheart cardiovascular disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- heart cardiovascular disease
- Sponsor
- Xiyuan Hospital, China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) consistent with NSTEMI diagnosis;
- •(2\) Aged 40 to 60 years;
- •(3\) patients should meet the diagnosis of TCM qi deficiency and blood stasis syndrome;
- •(4\) the cardiac function I and II level (NYHA heart function classification);
- •(5\) the patients did not take antibiotics, steroids, laxatives, antidiarrheals or probiotics within 3 months before enrollment;
- •(6\) the subject is informed and signs the informed consent voluntarily;
- •(7\) patients in cardiovascular ward.
Exclusion Criteria
- •(1\) renal insufficiency, male serum creatinine \>2\.5 mg/dl (\>220umo/l) female serum creatinine 2\.0 mg/dl (\>175umo/l);
- •(2\) significant liver disease or ALT and AST were 3 times higher than the normal upper limit;
- •(3\) after control, systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg (patients should sit for at least 5 minutes before blood pressure measurement);
- •(4\) diabetic patients with random blood glucose \>\=13\.7mmol/L or hemoglobin ALC \>\=9\.5%;
- •(5\) women who are pregnant or preparing to be pregnant, women who are nursing, and those who are allergic to the known components of the drug;
- •(6\) patients with acute cerebrovascular disease;
- •(7\) malignant tumor or life expectancy of the patient is less than 1 year;
- •(8\) patients with severe hematopoietic system diseases;
- •(9\) severe mental illness.
Outcomes
Primary Outcomes
Not specified
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