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

May 28, 2017 updated by: Jun Li
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
Drug: Lipid Regulating Drugs
Mainly including statins
Drug: Coronary Vasodilator
Mainly including nitrates
Drug: Shuanghe Decoction
Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.
Other: conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
Drug: Lipid Regulating Drugs
Mainly including statins
Drug: Coronary Vasodilator
Mainly including nitrates
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.
Experimental: Qi stagnation and blood stasis
Patients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
Drug: Lipid Regulating Drugs
Mainly including statins
Drug: Coronary Vasodilator
Mainly including nitrates
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.
Drug: Xuefu Zhuyu Decoction
Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
Experimental: 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.
Drug: Lipid Regulating Drugs
Mainly including statins
Drug: Coronary Vasodilator
Mainly including nitrates
Drug: Anti-Platelet Drugs
Including aspirin and clopidogrel, etc.
Drug: Gualou Xiebai Banxia Decoction & Danshen Decoction
Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Six months after drug intervention
Death caused by cardiovascular disease
Six months after drug intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial enzymes
Time Frame: At baseline and 4 weeks after drug intervention
The unit is mmol/L
At baseline and 4 weeks after drug intervention
Treadmill exercise test
Time Frame: At baseline and 4 weeks after drug intervention
The result will be positive or negative
At baseline and 4 weeks after drug intervention
The incidence of myocardial infarction or heart failure
Time Frame: Six months after drug intervention
Six months after drug intervention
Blood lipid
Time Frame: At baseline and 4 weeks after drug intervention
The unit is mmol/L.
At baseline and 4 weeks after drug intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 28, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 28, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXFJ-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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