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Clinical Trials/NCT03171597
NCT03171597
Unknown
Phase 4

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

Jun Li0 sites240 target enrollmentAugust 2017

Overview

Phase
Phase 4
Intervention
Anti-Platelet Drugs
Conditions
Unstable Angina
Sponsor
Jun Li
Enrollment
240
Primary Endpoint
Mortality
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2017
End Date
December 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jun Li
Responsible Party
Sponsor Investigator
Principal Investigator

Jun Li

Chief Physician

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Arms & Interventions

Qi stagnation and blood stasis

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

Intervention: Anti-Platelet Drugs

Qi deficiency and blood stasis

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

Intervention: Shuanghe Decoction

conventional western medicine

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

Intervention: Anti-Platelet Drugs

conventional western medicine

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

Intervention: Lipid Regulating Drugs

conventional western medicine

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

Intervention: Coronary Vasodilator

Qi deficiency and blood stasis

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

Intervention: Anti-Platelet Drugs

Qi deficiency and blood stasis

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

Intervention: Lipid Regulating Drugs

Qi deficiency and blood stasis

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

Intervention: Coronary Vasodilator

Qi stagnation and blood stasis

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

Intervention: Lipid Regulating Drugs

Qi stagnation and blood stasis

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

Intervention: Coronary Vasodilator

Qi stagnation and blood stasis

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

Intervention: Xuefu Zhuyu Decoction

Phlegm and blood stasis

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

Intervention: Anti-Platelet Drugs

Phlegm and blood stasis

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

Intervention: Lipid Regulating Drugs

Phlegm and blood stasis

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

Intervention: Coronary Vasodilator

Phlegm and blood stasis

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

Intervention: Gualou Xiebai Banxia Decoction & Danshen Decoction

Outcomes

Primary Outcomes

Mortality

Time Frame: Six months after drug intervention

Death caused by cardiovascular disease

Secondary Outcomes

  • Blood lipid(At baseline and 4 weeks after drug intervention)
  • Treadmill exercise test(At baseline and 4 weeks after drug intervention)
  • The incidence of myocardial infarction or heart failure(Six months after drug intervention)
  • Myocardial enzymes(At baseline and 4 weeks after drug intervention)

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