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

NCT04529148 | Unknown Phase 4

• 1 other identifier: WanbangdePharm
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

Stable Angina Pectoris Associated With Depression

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (5)

• The Short Form-36 Health Survey

  at the 0-week

• The Short Form-36 Health Survey

  at the 12-week

• Hamilton Depression Scale (HAMD-17)

  at the 0-week

• Hamilton Depression Scale (HAMD-17)

  at the 12-week

• Composite endpoint incidence of major adverse cardiovascular events (MACE)

  at the 12-week

Study Arms (2)

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

Interventions

Ginkgo biloba dropping pills，best western medicine treatment DRUG

oral

The treatment group

Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment DRUG

oral

The control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (4)

Foshan Chancheng Central Hospital

Foshan, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

Shenzhen Luohu District People's Hospital

Shenzhen, Guangdong, China

Location

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Guiyang, Guizhou, China

Location

Related Publications (2)

• 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.

  PMID: 37164472 DERIVED

• 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.

  PMID: 34910821 DERIVED

Central Study Contacts

Zhongqi Yang

CONTACT

0086-020-36591222; Yang_zhongqi@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 27, 2020
• Study Start: September 20, 2020
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)