Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease

March 20, 2018 updated by: Xiaoping Meng, Affiliated Hospital of Changchun University of Chinese Medicine

Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial

Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health

Study Overview

Status

Status

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

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

90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.

One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.

The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.

The secondary endpoint is:

  1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
  2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
  3. The maximum walking distance of 6-minute walk test;
  4. Changes of Seattle Angina Questionnaire;
  5. Hamilton Depression Scale/ Hamilton Anxiety Scale.

The safety evaluation criteria is:

  1. Adverse event and serious adverse event;
  2. Vital signs;
  3. Resting 12 lead ECG;
  4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).

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 (Anticipated)

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.
90

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 2

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
    • Ji Lin
      • Chang Chun, Ji Lin, China, 130021
        • Recruiting
        • Changchun Traditional Medicine University Affiliated Hospital
        • Contact:

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

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40 ~ 75, gender is not limited
  • Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
  • Sign the informed consent voluntarily

Exclusion Criteria:

  • History of hospitalization for acute coronary syndrome in past 3 months
  • Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg）
  • History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
  • In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
  • Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block
  • Severely allergic constitution, known or likely to be allergic to the test drug or its components
  • Known bleeding tendency or hemorrhagic disease
  • Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
  • Any other situations that researchers believe may affect the clinical research

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: Double

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.
Active Comparator: Treatment group
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
Drug: Yangxinshi pill
0.6g/tablet
Other Names:
  • STATE MEDICAL PERMISSION No.Z37021103
Drug: conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Other Names:
  • glyceryl trinitrate， beta-Blocking agent，etc
Placebo Comparator: Control group
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
Drug: conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Other Names:
  • glyceryl trinitrate， beta-Blocking agent，etc
Drug: Placebos
Yangxinshi simulant
Other Names:
  • Yangxinshi simulant

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
change in the maximum volume of O2 consumption
Time Frame: from baseline to 6 months
measured by gas analyzer
from baseline to 6 months

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
change in exercise tolerance
Time Frame: from baseline to 6 months
assessed by the distance (in meters) walked on 6-minute walk test
from baseline to 6 months
change in left ventricular ejection fraction (in percentage)
Time Frame: from baseline to 6 months
assessed by echocardiographic examination
from baseline to 6 months

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
Adverse events
Time Frame: 24 months
Number of treatment-related adverse events as assessed by CTCAE4.0
24 months

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.
Affiliated Hospital of Changchun University of Chinese Medicine

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: Xiaoping Meng, Doctor, Changchun Traditional Medicine University Affiliated Hospital

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.
June 1, 2017

Primary Completion (Anticipated)

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.
May 2, 2020

Study Completion (Anticipated)

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.
August 25, 2020

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).
February 11, 2018

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.
March 20, 2018

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.
March 27, 2018

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.
March 27, 2018

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.
March 20, 2018

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.
March 1, 2018

More Information

Terms related to this study

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.
  • GFH-C04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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