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Prospective clinical study on the syndrome standard of

A prospective, multicenter, randomized, double-blind placebo-controlled clinical study of Qingxin Jieyu Formula in the treatment of acute coronary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005796
Enrollment
Unknown
Registered
2022-04-03
Start date
2022-04-15
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

acute coronary syndrome

Interventions

Control group:Qingxin Jieyu Formula placebo granules 1 bag, twice a day
Experimental group:Qingxin Jieyu Formula granules 1 bag, twice a day

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: ? Meet the western diagnostic criteria of non-ST-segment elevation myocardial infarction or unstable angina pectoris; (2) The syndrome differentiation of TCM is the syndrome of "stasis and poison mutual knot"; ?18 = age =85; ? Participate in the clinical trial voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: ? Uncontrolled hypertension after drug treatment (systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg); ? Increased risk of bleeding: previous hemorrhagic stroke; Intracranial aneurysm; Trauma or major surgery (including bypass surgery) within 1 month; Current disease with active bleeding, etc. ? Patients with a history of gastrointestinal ulcer, massive gastrointestinal bleeding or current positive fecal occult blood; (4) Severe organic heart disease, such as LVEF<35% or NYHA/Killip cardiac function grade IV; (5) Those who have a history of malignant arrhythmia (arrhythmia with hemodynamic influence, requiring drugs or electrical cardioversion, or requiring cardiopulmonary resuscitation), a history of congenital heart disease, or malignant tumor within the past 1 year or so are considered by researchers to be unable to participate in the study; ? Severe liver and renal insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3× the upper limit of normal value (ULN) or total bilirubin (TBIL) =2×ULN; Or creatinine clearance (Ccr<30ml/min); ? In pregnancy (pregnancy is defined as a positive blood pregnancy test), lactating women; (8) blood donation history or significant blood loss within the last 3 months (=400ml); ? Persons with a history of alcohol abuse (i.e., men who drink more than 28 standard units per week and women who drink more than 21 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 25mL 40% alcohol spirits or 150mL wine); Or regular alcohol consumption (i.e., more than 14 standard units per week) in the 6 months prior to screening; ? Those with a history of drug abuse or dependence within 1 year prior to screening; ?Persons who have participated in other clinical trials and taken experimental drugs within the last 3 months; ?Infinitely allergic or intolerant to aspirin or P2Y12 receptor inhibitors; ? Histami is allergic to the test drug ingredients; ? Other circumstances which the investigator considers inappropriate for participating in the study.

Design outcomes

Primary

MeasureTime frame
Troponin T;creatine kinase-MB;Syndrome scale of stasis and poison interaction;adverse event;Seattle Angina Scale (SAQ) score;

Secondary

MeasureTime frame
N-terminal b-type natriuretic peptide precursor;Hs-CRP;left ventricular ejection fraction;Platelet aggregation rate;serum lipid level;coagulation function ;IL-1ß;IL-6;

Countries

China

Contacts

Public ContactGAO ZHUYE

Xiyuan Hospital of China Academy of Chinese Medical Sciences

zhuyegao@126.com13146201102

Outcome results

None listed

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