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Clinical trial of Ginkgo Biloba Leaf Dropping Pills in the treatment of Coronary Heart Disease Stable Angina with depressive symptoms

Clinical trial of Ginkgo Biloba Leaf Dropping Pills in the treatment of Coronary Heart Disease Stable Angina with depressive symptoms

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066908
Enrollment
Unknown
Registered
2022-12-21
Start date
2020-05-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Coronary Heart Disease Stable Angina with depressive symptoms

Interventions

treatment group:Ginkgo biloba leaf dropping pills
control group:placebo

Sponsors

First Affiliated Hospital of Guang zhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18-75 years, regardless of gender; 2. Clearly understand and voluntarily participate in the study, and sign the informed consent form; 3. In accordance with the diagnosis of coronary heart disease, and the following diagnostic criteria meet at least one of the following criteria: ? a clear history of myocardial infarction; ? received coronary artery revascularization; ? coronary angiography or coronary angiography results show that at least one coronary artery stenosis and lumen stenosis = 50%; ? cardiac magnetic resonance imaging or radionuclide myocardial perfusion imaging or cardiac color Doppler diagnosis Coronary heart disease with myocardial ischemia; 4. Consistent with the diagnosis of stable angina pectoris; 5. Stable angina pectoris has been treated according to the clinical guidelines and has been stable for at least 4 weeks; 6. Meet the diagnostic criteria for depressive episode in the international statistical classification of diseases and related health problems (ICD-10); HAMD-17 score = 18 and = 24; 7. In the past 7 days, patients have not used any food that has an impact on intestinal flora, such as foods containing probiotics (such as yogurt) or drugs (such as antibiotics).

Exclusion criteria

Exclusion criteria: 1. Acute myocardial events, unstable angina pectoris, severe heart failure; serious arrhythmia; severe or poorly controlled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg); sitting blood pressure, systolic blood pressure = 85 mmHg or symptomatic hypotension; severe primary diseases of liver, kidney and hematopoietic system, or serious diseases affecting their survival (such as tumor, etc.). 2. Serious suicidal tendency; HAMD-17 item 3 = 3; bipolar disorder depression attack in patients with epilepsy history, or depression secondary to other mental or physical diseases; alcohol and drug dependence within one year. 3. Abnormal liver and kidney function (ALT and / or AST > 3 times of the upper normal limit, and / or serum creatinine > 2 times of the upper normal limit); 4. Patients who are currently taking anti anxiety drugs; 5. Pregnant women, lactating women, women of childbearing age who do not take effective contraceptive measures, or who plan to conceive during the trial, and whose pregnancy test results are positive before the test; 6. Patients who have participated in clinical trials of other new drugs within 30 days before screening; 7. Other reasons caused patients not suitable to participate in the experiment; 8. Patients with allergic constitution or allergic to the ingredients contained in Ginkgo biloba leaf dropping pills;

Design outcomes

Primary

MeasureTime frame
SAQ;Frequency of angina pectoris related symptoms per week;

Secondary

MeasureTime frame
SF-36;incidence of MACE;HAMD-17;

Countries

China

Contacts

Public ContactYang Zhongqi

First Affiliated Hospital of Guang zhou University of Chinese Medicine

yang_zhongqi@163.com13688867618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026