Clinical trial NCT04529148: The Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression
Official title: Randomized, Double-masking, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina Pectoris Associated With Depression
Lead sponsor: Wanbangde Pharmaceutical Group Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
First posted: 2020-08-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical efficacy of Ginkgo biloba dropping pills on improving the frequency of angina pectoris and the life quality of patients with stable angina pectoris and depression symptoms on the basis of the best western medicine treatment; Study on the clinical pharmacological mechanism of Ginkgo biloba dropping pills.

Detailed description: This is a randomized, double-masking, placebo-controlled, multicenter clinical trial. The 72 subjects will be divided into experimental group and control group. The experimental group will be given Ginkgo biloba dropping pills (63mg / pill) , oral, 5 pills each time, three times a day. The control group will be given mimetic drug of ginkgo biloba dropping pills (63mg / pill) , oral, 5 pills each time, three times a day, for 12 weeks to evaluate the effect of Ginkgo biloba dropping pills on coronary heart disease Efficacy and safety of stable angina pectoris with depressive symptoms.

Eligibility criteria: Inclusion Criteria:

1. 18 to 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: ① have a clear history of myocardial infarction; ② have accept the treatment of coronary artery revascularization; ③ coronary radiography or coronary angiography results show that at least one coronary artery stenosis and lumen stenosis ≥ 50%; ④ 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)》 issued by the World Health Organization;
7. In the past 7 days, 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:

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 and systolic blood pressure ≤ 85 MmHg or symptomatic hypotension, severe primary diseases such as liver, kidney and hematopoietic system, or serious diseases affecting their survival (such as tumor, etc.);
2. Serious suicidal tendency; Hamilton Depression Scale item 3 ≥ 3; bipolar disorder depressive episode 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 CRE \> 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. Those who have participated in clinical trials of other new drugs within 30 days before screening;
7. Other reasons the researcher thinks it is not suitable to participate in the experiment;
8. Those with allergic constitution are allergic to the ingredients contained in Ginkgo biloba dropping pills;

Primary outcomes:
measure: Score of Seattle Angina Questionnaire（SAQ ）
timeFrame: at the 0-week
measure: Score of Seattle Angina Questionnaire（SAQ ）
timeFrame: at the 4-week
measure: Score of Seattle Angina Questionnaire（SAQ ）
timeFrame: at the 8-week
measure: Score of Seattle Angina Questionnaire（SAQ ）
timeFrame: at the 12-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 0-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 1-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 2-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 3-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 4-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 5-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 6-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 7-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 8-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 9-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 10-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 11-week
measure: Frequency of angina pectoris related symptoms every week
timeFrame: at the 12-week
Secondary outcomes:
measure: The Short Form-36 Health Survey
timeFrame: at the 0-week
measure: The Short Form-36 Health Survey
timeFrame: at the 12-week
measure: Hamilton Depression Scale (HAMD-17)
timeFrame: at the 0-week
measure: Hamilton Depression Scale (HAMD-17)
timeFrame: at the 12-week
measure: Composite endpoint incidence of major adverse cardiovascular events (MACE)
timeFrame: at the 12-week
Other outcomes:
Locations:
city: Foshan
country: China
facility: Foshan Chancheng Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Luohu District People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Second Affiliated Hospital of Guizhou University of Chinese Medicine
state: Guizhou
Study officials:
References:
citation: Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.