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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

Phase 1
Conditions
heart cardiovascular disease
Registration Number
ITMCTR2000002928
Lead Sponsor
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CRP;
Secondary Outcome Measures
NameTimeMethod
routine urianlysis;renal function;Routine detection of feces;blood routine examination;
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