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The traditional Chinese medicine Qingxin Jieyu granule in stable coronary artery disease with the blood-stasis and toxin syndrome: a multicenter randomized double-blind placebo-controlled trial

A clinical study on the efficacy of Qingxin Jieyu granule in the treatment of stable coronary artery disease with the blood-stasis and toxin syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000396
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-15
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

stable coronary artery disease

Interventions

Qingxin jieyu group:On the basis of the basic treatment for SCAD, take Qingxin Jieyu granule twice a day, one bag each time, for a total of 6 months.
Control group:On the basis of the basic treatment for SCAD, take the placebo of Qingxin Jieyu granule twice a day, one bag each time, for a total of 6 months.

Sponsors

Xiyuan hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age ranging from 18 to 80 years old, regardless of gender; (2) Meeting the diagnostic criteria of SCAD: definite history of MI, or coronary angiography or coronary CTA confirming that at least one branch of the coronary artery has = 50% stenosis, or those with stable conditions = 1 month after ACS treatment (PCI or drug intervention); (3) TCM syndrome differentiation belongs to the syndrome of mutual accumulation of blood stasis and toxin syndrome; (4) Angina pectoris CCS classification is grade ? - ?; (5) The subjects are informed and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Uncontrolled hypertension despite medical treatment (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); (2) Increased bleeding risk: history of previous hemorrhagic stroke; intracranial aneurysm; trauma or major surgery (including bypass surgery) within 1 month; currently suffering from active bleeding diseases, etc.; (3) Severe organic heart disease, such as patients with LVEF < 35% or NYHA/Killip cardiac function classification grade IV; (4) History of malignant arrhythmia within the recent 1 year (arrhythmia with hemodynamic impact, requiring drug or electrical cardioversion, or requiring cardiopulmonary resuscitation), history of congenital heart disease or malignancy, etc., which the researcher considers ineligible for the trial; (5) Severe liver and kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3×ULN or total bilirubin (TBIL) = 2×ULN; or creatinine clearance rate (Ccr < 30 ml/min); (6) Pregnant (pregnancy is defined as positive blood pregnancy test) or lactating women; (7) History of drug abuse or drug dependence within 1 year before screening; (8) Allergic constitution or allergy to known components of the investigational drug; (9) Other conditions that the researcher considers inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire;Integral of TCM syndromes;

Secondary

MeasureTime frame
Markers of inflammation;serum lipid parameter;cardiac function;ECG;major adverse cardiovascular events;cardiac uhrasonography;Secondary cardiovascular end points;

Countries

China

Contacts

Public ContactGao zhuye

Xiyuan hospital

zhuyegao@126.com13146201102

Outcome results

None listed

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