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Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.

Primary Purpose

Unstable Angina

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Anti-Platelet Drugs
Lipid Regulating Drugs
Coronary Vasodilator
Xuefu Zhuyu Decoction
Gualou Xiebai Banxia Decoction & Danshen Decoction
Shuanghe Decoction
Sponsored by
Jun Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina focused on measuring Unstable Angina, Traditional Chinese Medicine

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;

Patients have at least one of these symptoms:

  1. The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
  2. Angina pectoris during rest;
  3. The recent occurrence of angina pectoris caused by mild physical activity in the last month.

Exclusion Criteria:

  • Patients dignosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Experimental

    Experimental

    Experimental

    Arm Label

    conventional western medicine

    Qi deficiency and blood stasis

    Qi stagnation and blood stasis

    Phlegm and blood stasis

    Arm Description

    Patients in this group will be treated by conventional western medicine, including anti-platelet drugss,lipid regulating drugs, coronary vasodilator, etc.

    Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.

    Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.

    Patients in this group will be treated by Gualou Xiebai Banxia Decoction & Danshen Decoction at the base of conventional western medicine.

    Outcomes

    Primary Outcome Measures

    Mortality
    Death caused by cardiovascular disease

    Secondary Outcome Measures

    Myocardial enzymes
    The unit is mmol/L
    Blood lipid
    The unit is mmol/L.
    Treadmill exercise test
    The result will be positive or negative
    The incidence of myocardial infarction or heart failure

    Full Information

    First Posted
    May 28, 2017
    Last Updated
    May 28, 2017
    Sponsor
    Jun Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03171597
    Brief Title
    Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.
    Official Title
    Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jun Li

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the clinical efficacy of the famous prescription in the treatment of unstable angina pectoris. All of the patients will be divided into 4 arms according to their syndrome type. One of the arms will be treated by conventional western medicine, the other three will be treated by different Chinese herbal medicine prescription at the base of conventional western medicine.
    Detailed Description
    Xuefu Zhuyu Decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome. GualouXiebaiBanxia Decoction compounded with Danshen Decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type. Shuanghe Decoction has the function of supplementing Qi and activating blood circulation, which will be used to treat patients with Qi deficiency and blood stasis syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unstable Angina
    Keywords
    Unstable Angina, Traditional Chinese Medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional western medicine
    Arm Type
    Other
    Arm Description
    Patients in this group will be treated by conventional western medicine, including anti-platelet drugss,lipid regulating drugs, coronary vasodilator, etc.
    Arm Title
    Qi deficiency and blood stasis
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
    Arm Title
    Qi stagnation and blood stasis
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
    Arm Title
    Phlegm and blood stasis
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be treated by Gualou Xiebai Banxia Decoction & Danshen Decoction at the base of conventional western medicine.
    Intervention Type
    Drug
    Intervention Name(s)
    Anti-Platelet Drugs
    Intervention Description
    Including aspirin and clopidogrel, etc.
    Intervention Type
    Drug
    Intervention Name(s)
    Lipid Regulating Drugs
    Intervention Description
    Mainly including statins
    Intervention Type
    Drug
    Intervention Name(s)
    Coronary Vasodilator
    Intervention Description
    Mainly including nitrates
    Intervention Type
    Drug
    Intervention Name(s)
    Xuefu Zhuyu Decoction
    Intervention Description
    Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
    Intervention Type
    Drug
    Intervention Name(s)
    Gualou Xiebai Banxia Decoction & Danshen Decoction
    Intervention Description
    Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.
    Intervention Type
    Drug
    Intervention Name(s)
    Shuanghe Decoction
    Intervention Description
    Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    Death caused by cardiovascular disease
    Time Frame
    Six months after drug intervention
    Secondary Outcome Measure Information:
    Title
    Myocardial enzymes
    Description
    The unit is mmol/L
    Time Frame
    At baseline and 4 weeks after drug intervention
    Title
    Blood lipid
    Description
    The unit is mmol/L.
    Time Frame
    At baseline and 4 weeks after drug intervention
    Title
    Treadmill exercise test
    Description
    The result will be positive or negative
    Time Frame
    At baseline and 4 weeks after drug intervention
    Title
    The incidence of myocardial infarction or heart failure
    Time Frame
    Six months after drug intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA; Patients have at least one of these symptoms: The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration; Angina pectoris during rest; The recent occurrence of angina pectoris caused by mild physical activity in the last month. Exclusion Criteria: Patients dignosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Panpan Tian
    Phone
    +86 15652388175
    Email
    15652388175@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

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23737852
    Citation
    Wang J, Yang X, Chu F, Chen J, He Q, Yao K, Teng F, Gao Y, Xing Y, Wu A, Xing Y. The effects of xuefu zhuyu and shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:896467. doi: 10.1155/2013/896467. Epub 2013 May 8.
    Results Reference
    background
    PubMed Identifier
    23762142
    Citation
    Wang J, Yu G. A Systems Biology Approach to Characterize Biomarkers for Blood Stasis Syndrome of Unstable Angina Patients by Integrating MicroRNA and Messenger RNA Expression Profiling. Evid Based Complement Alternat Med. 2013;2013:510208. doi: 10.1155/2013/510208. Epub 2013 May 14.
    Results Reference
    result
    PubMed Identifier
    25254054
    Citation
    Yi GZ, Qiu YQ, Xiao Y, Yuan LX. The usefulness of xuefu zhuyu tang for patients with angina pectoris: a meta-analysis and systematic review. Evid Based Complement Alternat Med. 2014;2014:521602. doi: 10.1155/2014/521602. Epub 2014 Aug 31.
    Results Reference
    result
    PubMed Identifier
    22536282
    Citation
    Qiu Y, Xu H, Shi D. Traditional chinese herbal products for coronary heart disease: an overview of cochrane reviews. Evid Based Complement Alternat Med. 2012;2012:417387. doi: 10.1155/2012/417387. Epub 2012 Mar 28.
    Results Reference
    result
    PubMed Identifier
    27777598
    Citation
    Liu W, Xiong X, Yang X, Chu F, Liu H. The Effect of Chinese Herbal Medicine Gualouxiebaibanxia Decoction for the Treatment of Angina Pectoris: A Systematic Review. Evid Based Complement Alternat Med. 2016;2016:8565907. doi: 10.1155/2016/8565907. Epub 2016 Sep 29.
    Results Reference
    result

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    Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.

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