Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）

December 12, 2023 updated by: Wang Xian, Dongzhimen Hospital, Beijing

Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study

This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of conventional treatment can improve exercise tolerance of patients with chronic coronary syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS patients were randomly divided into two groups. In addition to conventional treatment, the experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Li Xianlun, Professor
      • Beijing, Beijing, China
        • Not yet recruiting
        • Dongzhimen Hospital Beijing University of Chinese Medicine
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Luo Suxin, Professor
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
          • Chen Qiuxiong, Professor
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Liu Gang, Professor
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of CM
        • Contact:
          • Wang Yongxia, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All the following criteria must be met to participate in the study:

  1. Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
  2. Meet the TCM standard of Qi deficiency and blood stasis syndrome
  3. MET < 5 measured by cardiopulmonary exercise test (treadmill)
  4. Age between 18 and 75 years (including both age limits), with no limitation on sex
  5. Understanding and voluntarily signing the written informed consent

Exclusion Criteria:

All the following criteria must not be met to participate in the study:

  1. Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
  2. Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
  3. Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
  4. Individuals with a revascularization plan within a month
  5. Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
  6. Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
  7. Individuals with New York Heart Association (NYHA) cardiac function class III and IV
  8. Individuals with acute cerebrovascular disease
  9. Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
  10. Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
  11. Individuals with allergies or abnormal drug reactions to the test drugs
  12. Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
  13. Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
  14. Individuals who have participated in other clinical trials within the past 3 months
  15. Individuals unsuitable for the clinical trials, as determined by the researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Yangxinshi tablets
Drug: Yangxinshi tablet
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
Other Names:
  • Yangxinshi
Placebo Comparator: Control group
Yangxinshi tablet simulants
Drug: Yangxinshi tablet simulants
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
Time Frame: 24 weeks
MET=Metabolic Equivalent of Task
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
anaerobic threshold
Time Frame: 24 weeks
Cardiopulmonary exercise test (treadmill)
24 weeks
oxygen pulse
Time Frame: 24 weeks
Cardiopulmonary exercise test (treadmill)
24 weeks
maximal exercise ventilation
Time Frame: 24 weeks
Cardiopulmonary exercise test (treadmill)
24 weeks
electrocardiogram (ECG)
Time Frame: 24 weeks
Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test
24 weeks
CCS angina classification
Time Frame: 24 weeks
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
24 weeks
Seattle Angina Questionnaire
Time Frame: 24 weeks
The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)
24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 24 weeks
score range: 0~21，higher scores mean a worse outcome.
24 weeks
General Anxiety Disorder-7 (GAD-7)
Time Frame: 24 weeks
score range: 0~21，higher scores mean a worse outcome.
24 weeks
Patient Health Questionnaire (PHQ-9)
Time Frame: 24 weeks
score range: 0-27，higher scores mean a worse outcome.
24 weeks
Traditional Chinese medicine (TCM) Syndrome Score
Time Frame: 24 weeks
the main symptoms score range: 2-6，the secondary symptoms score range: 1-3，higher scores mean a worse outcome.
24 weeks
Hospitalization within 6 months of taking the medicine
Time Frame: 24 weeks
total hospitalization time and hospitalization frequency
24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver function
Time Frame: 24 weeks
alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (γ-GT)
24 weeks
Renal function
Time Frame: 24 weeks
blood urea nitrogen (BUN) and serum creatinine (Scr)
24 weeks
Myocardial markers
Time Frame: 24 weeks
creatine kinase (CK), troponin I (TnI) (if not available, troponin T (TnT)), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)
24 weeks
Blood lipids
Time Frame: 24 weeks
cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dongzhimen Hospital, Beijing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wang Xian, Dongzhimen Hospital, Beijing University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Growful2201YXS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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