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Unstable AnginaPhase 4NCT03179527

Research on the Clinical Effect of Shuanghe Decoction in Treating Unstable Angina.

A Phase 4 study testing Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator in people with Unstable Angina, run by Jun Li.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the clinical efficacy of Shuanghe Decoction in the treatment of unstable angina. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, and the other one will be treated by Shuanghe Decoction at the base of conventional western… Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Unstable Angina
What is being tested?
Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jul 2017to Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients diagnosed 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.

Trial locations and contacts

No sites are listed yet.

Panpan Tian contact

+86 15652388175

15652388175@163.com

About this study

This study evaluates the clinical efficacy of Shuanghe Decoction in the treatment of unstable angina. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, and the other one will be treated by Shuanghe Decoction at the base of conventional western medicine.

Read the detailed description

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.

Conditions
Unstable Angina
Being tested
Anti-Platelet Drugs, Lipid Regulating Drugs, Coronary Vasodilator, Shuanghe Decoction
Keywords
Unstable Angina, Shuanghe Decoction
Medical subject headings
Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-Platelet DrugsDrug

    Including aspirin and clopidogrel, etc

  • Lipid Regulating DrugsDrug

    Mainly including statins

  • Coronary VasodilatorDrug

    Mainly including nitrates

  • Shuanghe DecoctionDrug

    Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.

Study groups in NCT03179527
Study groupRoleWhat they receive
Qi deficiency and blood stasisExperimentalPatients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
Receives: Drug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator; Drug: Shuanghe Decoction
Conventional western medicineOtherPatients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
Receives: Drug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Death caused by cardiovascular disease

    Measured: Six months after drug intervention

Secondary outcomes (4)

  1. Myocardial enzymes

    The unit is mmol/L

    Measured: At baseline and 4 weeks after drug intervention

  2. Blood lipid

    The unit is mmol/L

    Measured: At baseline and 4 weeks after drug intervention

  3. Treadmill exercise test

    The result will be positive or negative

    Measured: At baseline and 4 weeks after drug intervention

  4. The incidence of myocardial infarction or heart failure

    Measured: Six months after drug intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study startJul 2017 (estimated)
  3. Primary completionOct 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179527
Sponsor's protocol ID
SHS-2017
Status last verified
Jun 2017
First submitted
5 Jun 2017
Last updated
7 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23762142

  • 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.

    PubMed 25254054

  • 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.

    PubMed 22536282

  • 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.

    PubMed 27777598

  • 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.

    PubMed 23737852

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anti-Platelet Drugs, Lipid Regulating Drugs and Coronary Vasodilator in people with Unstable Angina, run by Jun Li.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Panpan Tian (+86 15652388175, 15652388175@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Six months after drug intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179527, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.

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