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Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

Primary Purpose

Coronary Heart Disease, Stable Angina

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Xueshuanxinmaining tablet
Xueshuanxinmaining placebo
Nitroglycerin tablets
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants are aged between 40 and 75 years.
  • Meet the diagnostic criteria of stable angina pectoris.
  • Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.
  • Voluntarily participate and sign informed consent.

Exclusion Criteria:

  • Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
  • Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.
  • Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
  • Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
  • With a history of alcohol and drug abuse.
  • Pregnant or lactating women.
  • Patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Xueshuanxinmaining Tablet

    Placebo

    Arm Description

    Patients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

    Patients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

    Outcomes

    Primary Outcome Measures

    Stopping or reducing rate of antianginal drugs
    Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.

    Secondary Outcome Measures

    Stopping or reducing rate of antianginal drugs
    Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
    Changes of electrocardiogram (ECG)
    Mainly observe the ST segment and the change of T wave from the baseline
    Changes of Seattle Angina Questionnaire scores (SAQ scores)
    The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. higher scores mean a better outcome.

    Full Information

    First Posted
    February 12, 2020
    Last Updated
    November 11, 2020
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04270279
    Brief Title
    Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris
    Official Title
    Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
    Detailed Description
    Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease, Stable Angina
    Keywords
    Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Xueshuanxinmaining Tablet
    Arm Type
    Experimental
    Arm Description
    Patients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.
    Intervention Type
    Drug
    Intervention Name(s)
    Xueshuanxinmaining tablet
    Other Intervention Name(s)
    XSXMN
    Intervention Description
    A kind of Chinese patent medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Xueshuanxinmaining placebo
    Other Intervention Name(s)
    XSXMN placebo
    Intervention Description
    The simulant of Xueshuanxinmaining tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Nitroglycerin tablets
    Intervention Description
    Be used when angina attack
    Primary Outcome Measure Information:
    Title
    Stopping or reducing rate of antianginal drugs
    Description
    Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
    Time Frame
    Eight weeks after treatment
    Secondary Outcome Measure Information:
    Title
    Stopping or reducing rate of antianginal drugs
    Description
    Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.
    Time Frame
    Two, four and eight weeks after treatment
    Title
    Changes of electrocardiogram (ECG)
    Description
    Mainly observe the ST segment and the change of T wave from the baseline
    Time Frame
    Four and eight weeks after treatment
    Title
    Changes of Seattle Angina Questionnaire scores (SAQ scores)
    Description
    The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. higher scores mean a better outcome.
    Time Frame
    Four and eight weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants are aged between 40 and 75 years. Meet the diagnostic criteria of stable angina pectoris. Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome. Voluntarily participate and sign informed consent. Exclusion Criteria: Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases. Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year. Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases. Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value. With a history of alcohol and drug abuse. Pregnant or lactating women. Patients who have participated in clinical trials of other drugs within 3 months before enrollment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Li, MD
    Phone
    +86 13051458913
    Email
    gamyylj@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Li, MD
    Organizational Affiliation
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

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