The Efficacy and Safety of Ginkgo Biloba Dropping Pills i... | NCT04529148

NCT04529148

Status Module

Name	Class
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The treatment group	Experimental	Ginkgo biloba dropping pills (63mg / pill), oral, 5 pills each time, three times a day,12 weeks totally. ( Continued to receive the best western medicine treatment for stable angina pectoris of coronary heart disease during the observation period.)	Drug: Ginkgo biloba dropping pills，best western medicine treatment
The control group	Placebo Comparator	Mimetic drug of ginkgo biloba dropping pills (63mg / pill),oral, 5 pills each time, three times a day,12 weeks totally.( Continued to receive the best western medicine treatment for stable angina pectoris of coronary heart disease during the observation period.)	Drug: Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment

Name	Type	Description	Arm Group Labels	Other Names
Ginkgo biloba dropping pills，best western medicine treatment	Drug	oral	The treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score of Seattle Angina Questionnaire（SAQ ）	Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) × 100. The higher the score, the better the quality of life and body function.	at the 0-week
Score of Seattle Angina Questionnaire（SAQ ）	Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) × 100. The higher the score, the better the quality of life and body function.	at the 4-week
Score of Seattle Angina Questionnaire（SAQ ）	Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) × 100. The higher the score, the better the quality of life and body function.	at the 8-week
Score of Seattle Angina Questionnaire（SAQ ）	Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) × 100. The higher the score, the better the quality of life and body function.	at the 12-week
Frequency of angina pectoris related symptoms every week

Secondary Outcomes

Measure	Description	Time Frame
The Short Form-36 Health Survey	The 35 items of SF-36 quality of life scale were summarized into 8 dimensions. According to the influence degree of each item on the quality of life, the corresponding weight was given, and each dimension was converted into 100 points. The higher the score, the better the functional status and the higher the quality of life.	at the 0-week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 75 years , regardless of gender;
Clearly understand and voluntarily participate in the study, and sign the informed consent form;
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;
Consistent with the diagnosis of stable angina pectoris;
Stable angina pectoris has been treated according to the clinical guidelines and has been stable for at least 4 weeks;
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;
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:

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.);
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;
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);
Patients who are currently taking anti anxiety drugs;
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;
Those who have participated in clinical trials of other new drugs within 30 days before screening;
Other reasons the researcher thinks it is not suitable to participate in the experiment;
Those with allergic constitution are allergic to the ingredients contained in Ginkgo biloba dropping pills;

Name	Role	Phone	Extension	Email
Zhongqi Yang	Contact	0086-020-36591222		Yang_zhongqi@163.com

Facility	Status	City	State	ZIP	Country	Contacts
Foshan Chancheng Central Hospital		Foshan	Guangdong		China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37164472	Derived	Wu T, Li S, Li Z, Long W, Liu Q, Tang H, Huang X, Tang Y, Dong X, Ning Y, Tian S, Xu T, Xian SX, Liao H, Hong Y, Yang Z. Efficacy and safety of Ginkgo biloba dropping pills in the treatment of coronary heart disease with stable angina pectoris and depression: study protocol for a randomised, placebo-controlled, parallel-group, double-blind and multicentre clinical trial. BMJ Open. 2023 May 10;13(5):e055263. doi: 10.1136/bmjopen-2021-055263.
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