Effect of Gualou Xiebai Banxia Decoction With Danshen Decoction in Treating Unstable Angina.

Phase 4

• Conditions: Unstable Angina
• Interventions: Drug: Anti-Platelet Drugs; Drug: Lipid Regulating Drugs; Drug: Coronary Vasodilator; Drug: Gualou Xiebai Banxia Decoction & Danshen Decoction

• Registration Number: NCT03179514
• Lead Sponsor: Jun Li

Brief Summary

This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, the other one will be treated by Gualou Xiebai Banxia Decoction compounded with Danshen Decoction at the base of conventional western medicine.

Detailed Description

Gualou Xiebai Banxia 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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07
• Study Start: 2017-07
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phlegm and blood stasis	Anti-Platelet Drugs	Patients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine.
Phlegm and blood stasis	Lipid Regulating Drugs	Patients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine.
Phlegm and blood stasis	Coronary Vasodilator	Patients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine.
Phlegm and blood stasis	Gualou Xiebai Banxia Decoction & Danshen Decoction	Patients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine.
Conventional western medicine	Anti-Platelet Drugs	Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
Conventional western medicine	Lipid Regulating Drugs	Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
Conventional western medicine	Coronary Vasodilator	Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.

Primary Outcome Measures

Name	Time	Method
Mortality	Six months after drug intervention	Death caused by cardiovascular disease

Secondary Outcome Measures

Name	Time	Method
Myocardial enzymes	At baseline and 4 weeks after drug intervention	The unit is mmol/L
lood lipid The unit is mmol/L. Blood lipid	At baseline and 4 weeks after drug intervention	The unit is mmol/L.
Treadmill exercise test	At baseline and 4 weeks after drug intervention	The result will be positive or negative.
The incidence of myocardial infarction or heart failure	Six months after drug intervention] Inclusion Criteria: