TrialReader


Effect of Gualou Xiebai Banxia Decoction With Danshen Decoction in Treating Unstable Angina.

NCT03179514 — Phase 4, Unknown, 120 participants, Jun Li

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Research on the Clinical Effect of Gualou Xiebai Banxia Decoction Compounded With Danshen Decoction in Treating Unstable Angina.

RegistryNCT03179514
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, Gualou Xiebai Banxia Decoction & Danshen 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

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Unstable Angina All trials of Anti-Platelet Drugs All trials of Lipid Regulating Drugs

-Summary

This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with Danshen 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 Gualou Xiebai Banxia Decoction compounded with Danshen Decoction at the base of conventional western medicine.

Expand all sections  ·  Collapse all

+Detailed description

Gualou Xiebai Banxia 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.

+Arms and interventions

ArmTypeInterventionsDescription
Phlegm and blood stasisExperimentalDrug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator; Drug: Gualou Xiebai Banxia Decoction & Danshen DecoctionPatients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen 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
  • Gualou Xiebai Banxia Decoction & Danshen Decoction (Drug): Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza 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
  • lood lipid The unit is mmol/L. Blood lipid [At baseline and 4 weeks after drug intervention]: 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] Inclusion Criteria:]

+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: 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
  • 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

+Investigators

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

My Notes