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

Primary Purpose

Unstable Angina

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Anti-Platelet Drugs

Lipid Regulating Drugs

Coronary Vasodilator

Shuanghe Decoction

About this trial

This is an interventional treatment trial for Unstable Angina focused on measuring Unstable Angina, Shuanghe Decoction

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Qi deficiency and blood stasis

Conventional western medicine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mortality

Death caused by cardiovascular disease

Secondary Outcome Measures

Myocardial enzymes

The unit is mmol/L

Blood lipid

The unit is mmol/L

Treadmill exercise test

The result will be positive or negative

The incidence of myocardial infarction or heart failure

Full Information

NCT ID

NCT03179527

First Posted

June 5, 2017

Last Updated

June 5, 2017

Sponsor

Jun Li

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03179527

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2017 (Anticipated)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun Li

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unstable Angina

Keywords

Unstable Angina, Shuanghe Decoction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Qi deficiency and blood stasis

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional western medicine

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anti-Platelet Drugs

Intervention Description

Including aspirin and clopidogrel, etc

Intervention Type

Drug

Intervention Name(s)

Lipid Regulating Drugs

Intervention Description

Mainly including statins

Intervention Type

Drug

Intervention Name(s)

Coronary Vasodilator

Intervention Description

Mainly including nitrates

Intervention Type

Drug

Intervention Name(s)

Shuanghe Decoction

Intervention Description

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

Primary Outcome Measure Information:

Title

Mortality

Description

Death caused by cardiovascular disease

Time Frame

Six months after drug intervention

Secondary Outcome Measure Information:

Title

Myocardial enzymes

Description

The unit is mmol/L

Time Frame

At baseline and 4 weeks after drug intervention

Title

Blood lipid

Description

The unit is mmol/L

Time Frame

At baseline and 4 weeks after drug intervention

Title

Treadmill exercise test

Description

The result will be positive or negative

Time Frame

At baseline and 4 weeks after drug intervention

Title

The incidence of myocardial infarction or heart failure

Time Frame

Six months after drug intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Panpan Tian

Phone

+86 15652388175

15652388175@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Li, MD

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23762142

Citation

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.

Results Reference

result

PubMed Identifier

25254054

Citation

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.

Results Reference

result

PubMed Identifier

22536282

Citation

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.

Results Reference

result

PubMed Identifier

27777598

Citation

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.

Results Reference

result

PubMed Identifier

23737852

Citation

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.

Results Reference

result

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

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