The Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression
Primary Purpose
Stable Angina Pectoris Associated With Depression
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ginkgo biloba dropping pills,best western medicine treatment
Mimetic drug of ginkgo biloba dropping pills,best western medicine treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina Pectoris Associated With Depression
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;
Sites / Locations
- Foshan Chancheng Central Hospital
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- Shenzhen Luohu District People's Hospital
- The Second Affiliated Hospital of Guizhou University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The treatment group
The control group
Arm Description
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.)
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.)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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
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).
Full Information
NCT ID
NCT04529148
First Posted
August 20, 2020
Last Updated
August 23, 2020
Sponsor
Wanbangde Pharmaceutical Group Co., LTD
Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04529148
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2020 (Anticipated)
Primary Completion Date
September 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wanbangde Pharmaceutical Group Co., LTD
Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris Associated With Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The treatment group
Arm Type
Experimental
Arm Description
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.)
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba dropping pills,best western medicine treatment
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Mimetic drug of ginkgo biloba dropping pills,best western medicine treatment
Intervention Description
oral
Primary Outcome Measure Information:
Title
Score of Seattle Angina Questionnaire(SAQ )
Description
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.
Time Frame
at the 0-week
Title
Score of Seattle Angina Questionnaire(SAQ )
Description
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.
Time Frame
at the 4-week
Title
Score of Seattle Angina Questionnaire(SAQ )
Description
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.
Time Frame
at the 8-week
Title
Score of Seattle Angina Questionnaire(SAQ )
Description
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.
Time Frame
at the 12-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 0-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 1-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 2-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 3-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 4-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 5-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 6-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 7-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 8-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 9-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 10-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 11-week
Title
Frequency of angina pectoris related symptoms every week
Description
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.
Time Frame
at the 12-week
Secondary Outcome Measure Information:
Title
The Short Form-36 Health Survey
Description
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.
Time Frame
at the 0-week
Title
The Short Form-36 Health Survey
Description
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.
Time Frame
at the 12-week
Title
Hamilton Depression Scale (HAMD-17)
Description
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.
Time Frame
at the 0-week
Title
Hamilton Depression Scale (HAMD-17)
Description
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
Time Frame
at the 12-week
Title
Composite endpoint incidence of major adverse cardiovascular events (MACE)
Description
Record the major adverse cardiovascular events (MACE)(Mace including cardiovascular death, non fatal myocardial infarction, revascularization).
Time Frame
at the 12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongqi Yang
Phone
0086-020-36591222
Email
Yang_zhongqi@163.com
Facility Information:
Facility Name
Foshan Chancheng Central Hospital
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen Luohu District People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The Second Affiliated Hospital of Guizhou University of Chinese Medicine
City
Guiyang
State/Province
Guizhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34910821
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.
Results Reference
derived
Learn more about this trial
The Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression
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