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

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ClinicalTrials.gov Identifier: NCT03478332
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoping Meng, Affiliated Hospital of Changchun University of Chinese Medicine

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Yangxinshi pill Drug: conventional coronary heart disease medicine Drug: Placebos Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 2, 2020
Estimated Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: STATE MEDICAL PERMISSION No.Z37021103

Drug: conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Other Name: 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 Name: glyceryl trinitrate, beta-Blocking agent,etc

Drug: Placebos
Yangxinshi simulant
Other Name: Yangxinshi simulant




Primary Outcome Measures :
  1. change in the maximum volume of O2 consumption [ Time Frame: from baseline to 6 months ]
    measured by gas analyzer


Secondary Outcome Measures :
  1. change in exercise tolerance [ Time Frame: from baseline to 6 months ]
    assessed by the distance (in meters) walked on 6-minute walk test

  2. change in left ventricular ejection fraction (in percentage) [ Time Frame: from baseline to 6 months ]
    assessed by echocardiographic examination


Other Outcome Measures:
  1. Adverse events [ Time Frame: 24 months ]
    Number of treatment-related adverse events as assessed by CTCAE4.0



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478332


Contacts
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Contact: Xiaoping Meng, Doctor 8618994127461 18994127461@163.com

Locations
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China, Ji Lin
Changchun Traditional Medicine University Affiliated Hospital Recruiting
Chang Chun, Ji Lin, China, 130021
Contact: Xiaoping Meng, Doctor    8618994127461    18994127461@163.com   
Sponsors and Collaborators
Affiliated Hospital of Changchun University of Chinese Medicine
Investigators
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Principal Investigator: Xiaoping Meng, Doctor Changchun Traditional Medicine University Affiliated Hospital

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Responsible Party: Xiaoping Meng, chief physician, Affiliated Hospital of Changchun University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03478332     History of Changes
Other Study ID Numbers: GFH-C04
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Nitroglycerin
Vasodilator Agents