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

Unstable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03179527
• Other study ID #: SHS-2017
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 5, 2017
• Last updated: June 5, 2017
• Start date: July 2017
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Panpan Tian
• Phone: +86 15652388175
• Email: 15652388175[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Unstable Angina

Intervention

Drug:
• Anti-Platelet Drugs
Including aspirin and clopidogrel, etc
• Lipid Regulating Drugs
Mainly including statins
• Coronary Vasodilator
Mainly including nitrates
• Shuanghe Decoction
Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jun Li	Guang'anmen Hospital of China Academy of Chinese Medical Sciences

References & Publications (5)

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. Epub 2016 Sep 29. Review. — View 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. — View 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 intervent — View 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: 10.1155/20 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death caused by cardiovascular disease	Six months after drug intervention
Secondary	Myocardial enzymes	The unit is mmol/L	At baseline and 4 weeks after drug intervention
Secondary	Blood lipid	The unit is mmol/L	At baseline and 4 weeks after drug intervention
Secondary	Treadmill exercise test	The result will be positive or negative	At baseline and 4 weeks after drug intervention
Secondary	The incidence of myocardial infarction or heart failure		Six months after drug intervention