A Randomized Controlled Study on the Intervention of Qixue Bingzhi Formula in Stable Coronary Heart Disease Patients with Qi Stagnation and Blood Stasis Type and Anxiety and Depression

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082590

Enrollment

Unknown

Registered

2024-04-01

Start date

2024-04-01

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Stable coronary heart disease complicated with anxiety and depression

Interventions

Test group:Standardized western medicine treatment of coronary heart disease plus Qixue Bingzhi Formula

control group:Standardized western medicine treatment of coronary heart disease plus placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)History of acute myocardial infarction or at least one major branch of epicardial coronary stenosis = 50% confirmed by coronary angiography or coronary computed tomography angiography (CTA). (2)Stable symptoms of CHD for more than 1 year. (3)Confirmed to TCM syndrome of Qi stagnation and blood stasis type: chest pain and tightness, fullness in the chest and sub-costal region, palpitations, purple lips and tongue, and hesitant pulse. (4)GAD-7 and PHQ-9 scales indicate a score range of 5-14 points. (5)Age 18–75 years, either sex.

Exclusion criteria

Exclusion criteria: (1)Combiend with myocarditis, cardiomyopathy, pericarditis, rheumatic heart disease, and valvular heart disease. (2)LVEF measured by echocardiography, radionuclide or cardiac catheterization is less than 30%. (3)Combined malignant arrhythmia. (4)Individuals who are unable to participate in cardiopulmonary exercise tests. (5)Combined with other serious diseases, such as severe liver and kidney dysfunction. (6)Malignant tumors. (7)Epilepsy patients. (8)Individuals with bipolar disorder, cyclic mood disorder, schizophrenia, schizophrenic affective disorder, or severe cognitive impairment who are unable to communicate. (9)Patients take antidepressant and anxiety medication within the past 4 weeks. (10)Pregnant and lactating women. (11)Patients who are allergic to multiple drugs. (12)Participating in other clinical trials now or within 3 months. Refusing to sign informed consent form.

Design outcomes

Primary

Measure	Time frame
Seattle Angina Questionnaiire score;	—

Secondary

Measure	Time frame
electrocardiogram;Patient health questionnaire-9;Generalized Anxiety Disorder;Pittsburgh sleep quality index;Traditional Chinese Medicine syndrome score;C-reactive protein;Interleukin-6;tumor necrosis factor-a;thrombocytin;catecholamines;Blood lipids;	—

Countries

China

Contacts

Public ContactLi Shengyao

Xiyuan Hospital,China Academy of Chinese Medical Sciences

lsycardio@163.com+86 152 1002 0358

Outcome results

None listed

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