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

NCT ID: NCT03171597

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Unstable Angina

Keywords

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Unstable Angina Traditional Chinese Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional western medicine

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

Group Type OTHER

Anti-Platelet Drugs

Intervention Type DRUG

Including aspirin and clopidogrel, etc.

Lipid Regulating Drugs

Intervention Type DRUG

Mainly including statins

Coronary Vasodilator

Intervention Type DRUG

Mainly including nitrates

Qi deficiency and blood stasis

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

Group Type EXPERIMENTAL

Anti-Platelet Drugs

Intervention Type DRUG

Including aspirin and clopidogrel, etc.

Lipid Regulating Drugs

Intervention Type DRUG

Mainly including statins

Coronary Vasodilator

Intervention Type DRUG

Mainly including nitrates

Shuanghe Decoction

Intervention Type DRUG

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

Qi stagnation and blood stasis

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

Group Type EXPERIMENTAL

Anti-Platelet Drugs

Intervention Type DRUG

Including aspirin and clopidogrel, etc.

Lipid Regulating Drugs

Intervention Type DRUG

Mainly including statins

Coronary Vasodilator

Intervention Type DRUG

Mainly including nitrates

Xuefu Zhuyu Decoction

Intervention Type DRUG

Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.

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.

Group Type EXPERIMENTAL

Anti-Platelet Drugs

Intervention Type DRUG

Including aspirin and clopidogrel, etc.

Lipid Regulating Drugs

Intervention Type DRUG

Mainly including statins

Coronary Vasodilator

Intervention Type DRUG

Mainly including nitrates

Gualou Xiebai Banxia Decoction & Danshen Decoction

Intervention Type DRUG

Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.

Interventions

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Anti-Platelet Drugs

Including aspirin and clopidogrel, etc.

Intervention Type DRUG

Lipid Regulating Drugs

Mainly including statins

Intervention Type DRUG

Coronary Vasodilator

Mainly including nitrates

Intervention Type DRUG

Xuefu Zhuyu Decoction

Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.

Intervention Type DRUG

Gualou Xiebai Banxia Decoction & Danshen Decoction

Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.

Intervention Type DRUG

Shuanghe Decoction

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Li

OTHER

Sponsor Role lead

Responsible Party

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Jun Li

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun Li, MD

Role: STUDY_DIRECTOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Central Contacts

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Panpan Tian

Role: CONTACT

Phone: +86 15652388175

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23737852 (View on PubMed)

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.

Reference Type RESULT
PMID: 23762142 (View on PubMed)

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.

Reference Type RESULT
PMID: 25254054 (View on PubMed)

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.

Reference Type RESULT
PMID: 22536282 (View on PubMed)

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.

Reference Type RESULT
PMID: 27777598 (View on PubMed)

Other Identifiers

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YXFJ-2017

Identifier Type: -

Identifier Source: org_study_id