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A clinical study on the biological basis of abnormal platelet function in blood stasis syndrome

A clinical study on the biological basis of abnormal platelet function in blood stasis syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100041998
Enrollment
Unknown
Registered
2021-01-12
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood stasis

Interventions

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In this study, a total of four groups of subjects were included, namely, patients with atherosclerosis, coronary heart disease and cerebral infarction with syndrome differentiation of blood stasis, and normal subjects were taken as the unified control group. The disease group first met the common inclusion criteria: (1) Age 40-85 (including boundary age), regardless of gender; (2) TCM syndrome of blood stasis or qi deficiency and blood stasis; (3) Imaging examination showed evidence of arterial intima thickening or plaque (4) those who have never used or have not used antiplatelet/anticoagulant drugs regularly; (5) Participate voluntarily and sign informed consent. Inclusion criteria for atherosclerosis subjects: (1) Meet the diagnostic criteria of atherosclerosis with hyperlipidemia; (2) Patients with IMT >= 1.0mm or visible plaque, and the degree of carotid artery stenosis = 2 and <= 33. Inclusion criteria of normal control group: (1) Ages 40-85, regardless of gender; (2) TCM syndrome differentiation without deficiency of qi and blood stasis; (3) There were no abnormalities in routine physical examination, vital signs (temperature, blood pressure, heart rate, respiration), electrocardiogram and laboratory examination (including blood, urine, stool routine, liver, renal function and other biochemical indicators); (4) Medical history of centerless blood, lung, liver, kidney, digestive tract, nervous system, blood system, mental disorders, metabolic abnormalities that affect the coagulation function. (5) No recent trauma or surgical history; (6) Recently did not take anti-platelet drugs, steroids or non-steroidal anti-inflammatory drugs; (7) Did not participate in other drug clinical trials within 1 month. (8) Voluntary and signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for disease group: Has one of the following circumstances: acute coronary syndrome (30 days), cardiac shock, drugs are difficult to control high blood pressure (systolic blood pressure or greater 180 MMHG and/or diastolic blood pressure, 110 MMHG or higher), ? ? degrees above sinus or atrioventricular block placement pacemaker therapy, difficult to control the malignant arrhythmia and hypertrophic obstructive cardiomyopathy, acute myocarditis, pulmonary embolism, severe valvular disease and cerebral hemorrhage, subarachnoid hemorrhage, because brain tumor, (1) the brain injury, blood disease caused by stroke patients and severe neurosis; (2) with the respiratory system, nervous system, digestive system, blood system, such as to severe anemia, thrombocytosis in disease, platelet function defect disease, etc.), the production system and the immune system, such as rheumatoid arthritis and systemic lupus erythematosus (sle), thrombocytopenia, etc.), such as serious illness, and malignant tumor patients, patients with severe trauma, infection, or nearly a month has a deep history of vascular puncture or surgery, etc.; (3) in patients with severe liver and kidney function impairment, the upper limit of alanine aminotransferase/alanine aminotransferase > was 3 times of normal value, and the serum creatinine was higher than the upper limit; (4) Diabetic patients with random blood glucose =13.7mmol/L or hemoglobin a1c =8%; (5) TCM syndrome differentiation combined with more obvious Yin deficiency or Yang deficiency; (6) a woman of childbearing age is pregnant or breast-feeding; (7) Have participated in or are participating in other clinical subjects in the past 1 month; (8) Persons with mental or neurological disorders and unable to express their wishes correctly; (9) Alcoholics and drug abusers and addicts. Exclusion criteria for normal control group: (1) Patients with blood system, immune system and other major systemic diseases, or malignant tumors, allergic constitution, or patients with severe trauma or infection; (2) Persons with poor control of chronic diseases such as hypertension and diabetes; (3) Women of childbearing age are pregnant or lactating; (4) Persons with mental or neurological disorders and unable to express their wishes correctly; (5) Alcoholics and drug abusers and addicts.

Design outcomes

Primary

MeasureTime frame
Platelet aggregation experiment;

Countries

China

Contacts

Public ContactLiu Jianxun

Xiyuan Hospital

liujx0324@sina.com+86 13701090121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026