Stable Angina Pectoris Associated With DepressionPhase 4NCT04529148

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

A Phase 4 study testing Ginkgo biloba dropping pills，best western medicine treatment and Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment in people with Stable Angina Pectoris Associated With Depression, run by Wanbangde Pharmaceutical Group Co., LTD at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Stable Angina Pectoris Associated With Depression
What is being tested?: Ginkgo biloba dropping pills，best western medicine treatment and Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 4 sitesChina
Study dates: 30 Nov 2020to 18 Aug 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

Trial locations and contacts

4 sites in 1 country.

China4 sites

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

Other trials in China

About this study

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

Read the 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.

Conditions: Stable Angina Pectoris Associated With Depression
Being tested: Ginkgo biloba dropping pills，best western medicine treatment, Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ginkgo biloba dropping pills，best western medicine treatmentDrug
oral
Mimetic drug of ginkgo biloba dropping pills，best western medicine treatmentDrug
oral

Study groups in NCT04529148
Study group	Role	What they receive
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.) Receives: 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.) Receives: Drug: Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the 12-week

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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）.
Measured: at the 12-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202018 Aug 2022

First posted27 Aug 2020
Study start30 Nov 2020
Primary completion18 Aug 2022
Study completion18 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stable Angina Pectoris Associated With DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04529148
Sponsor's protocol ID: NO.ZYYEC【2020】030
Status last verified: Aug 2026
First submitted: 20 Aug 2020
Last updated: 17 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37164472
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.
PubMed 34910821

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04529148
Acronym / sponsor ID: NO.ZYYEC【2020】030
Conditions: Stable Angina Pectoris Associated With Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
Collaborators: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study start: 30 Nov 2020 (actual)
Primary completion: 18 Aug 2022 (actual)
Study completion: 18 Aug 2022 (actual)
First posted: 27 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
The treatment group	Experimental	Drug: Ginkgo biloba dropping pills，best western medicine treatmentGinkgo 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.)
The control group	Placebo comparator	Drug: Mimetic drug of ginkgo biloba dropping pills，best western medicine treatmentMimetic 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.)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ginkgo biloba dropping pills，best western medicine treatmentoral	Drug	The treatment group
Mimetic drug of ginkgo biloba dropping pills，best western medicine treatmentoral	Drug	The control group

Primary outcome

Score of Seattle Angina Questionnaire（SAQ ）
Time frame: at the 0-week
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 ）
Time frame: at the 4-week
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 ）
Time frame: at the 8-week
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 ）
Time frame: at the 12-week
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
Time frame: at the 0-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
Time frame: at the 1-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
Time frame: at the 2-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
Time frame: at the 3-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
Time frame: at the 4-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
Time frame: at the 5-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
Time frame: at the 6-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
Time frame: at the 7-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
Time frame: at the 8-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
Time frame: at the 9-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
Time frame: at the 10-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
Time frame: at the 11-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
Time frame: at the 12-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.

5 secondary outcomes

The Short Form-36 Health Survey
Time frame: at the 0-week
The Short Form-36 Health Survey
Time frame: at the 12-week
Hamilton Depression Scale (HAMD-17)
Time frame: at the 0-week
Hamilton Depression Scale (HAMD-17)
Time frame: at the 12-week
Composite endpoint incidence of major adverse cardiovascular events (MACE)
Time frame: at the 12-week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Derived from this study: PubMed 37164472Wu 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.
Derived from this study: PubMed 34910821Tully 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of Seattle Angina Questionnaire（SAQ ） (time frame: at the 0-week). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529148, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.