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

NCT03179618 — Phase 4, Unknown, 120 participants, Jun Li

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RegistryNCT03179618
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment120 (Estimated)
SponsorJun Li (Other); collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ConditionsUnstable Angina
InterventionsAnti-Platelet Drugs, Lipid Regulating Drugs, Coronary Vasodilator, Xuefu Zhuyu Decoction (Drug)
Datesstart 2017-07-01 (estimated), primary completion 2019-10-01 (estimated), completion 2019-12-01 (estimated), first posted 2017-06-07, last updated 2017-06-07

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Qi stagnation and blood stasisExperimentalDrug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator; Drug: Xuefu Zhuyu DecoctionPatients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
Conventional western medicineOtherDrug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary VasodilatorPatients in this group will be treated by conventional western medicine, including anti-platelet drugss,lipid regulating drugs, coronary vasodilator, etc.
  • Anti-Platelet Drugs (Drug): Including aspirin and clopidogrel, etc.
  • Lipid Regulating Drugs (Drug): Mainly including statins
  • Coronary Vasodilator (Drug): Mainly including nitrates
  • Xuefu Zhuyu Decoction (Drug): Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.

+Outcome measures

Primary outcomes

  • Mortality [Six months after drug intervention]: Death caused by cardiovascular disease

Secondary outcomes

  • Myocardial enzymes [At baseline and 4 weeks after drug intervention]: The unit is mmol/L
  • 3. Blood lipid The unit is mmol/L. Blood lipid [At baseline and 4 weeks after drug intervention]: 3\. Blood lipid The unit is mmol/L. 3. Blood lipid The unit is mmol/L. The unit is mmol/L
  • Treadmill exercise test [At baseline and 4 weeks after drug intervention]: The result will be positive or negative
  • The incidence of myocardial infarction or heart failure [Six months after drug intervention]

+Eligibility

Sex: All, ages: 35 Years to 70 Years

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 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.

+Publications

  • Results publication: 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. PMID 25254054
  • Results publication: 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. PMID 22536282
  • Results publication: 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. PMID 27777598
  • Results publication: 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. PMID 23737852
  • Results publication: 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. PMID 23762142

+Investigators

  • Jun Li, MD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

My Notes