The Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Stable Angina Pectoris Associated With Depression
• Intervention / Treatment: Drug: Ginkgo biloba dropping pills，best western medicine treatment; Drug: Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhongqi Yang; Phone Number: 0086-020-36591222; Email: Yang_zhongqi@163.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Foshan Chancheng Central Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Shenzhen, Guangdong, China
      • Shenzhen Luohu District People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The treatment group; 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; oral
Placebo Comparator: The control group; 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; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 0-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 1-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 2-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 3-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 4-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 5-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 6-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 7-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 8-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 9-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 10-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 11-week
Frequency of angina pectoris related symptoms every week	With the help of questionnaire survey，we can judge whether there is angina pectoris，record the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.	at the 12-week

Secondary Outcome Measures

Outcome Measure	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
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 12-week
Hamilton Depression Scale (HAMD-17)	All items in the 17 items were scored，the scores of minimum values is 0, the maximum values is 52，the higher the score, the more serious the depression，after treatment，the score reduction rate ≥ 50% is defined as valid.	at the 0-week
Hamilton Depression Scale (HAMD-17)	All items in the 17 items were scored，the scores of minimum values is 0, the maximum values is 52，the higher the score, the more serious the depression，after treatment，the score reduction rate ≥ 50% is defined as valid	at the 12-week
Composite endpoint incidence of major adverse cardiovascular events (MACE)	Record the major adverse cardiovascular events (MACE)（Mace including cardiovascular death, non fatal myocardial infarction, revascularization）.	at the 12-week

Collaborators and Investigators

• Sponsor: Wanbangde Pharmaceutical Group Co., LTD
• Collaborators: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2020
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Depression; Depressive Disorder; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: WanbangdePharm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No