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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unstable Angina

Intervention / Treatment
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* Drug: Anti-Platelet Drugs
* Drug: Lipid Regulating Drugs
* Drug: Coronary Vasodilator
* Drug: Shuanghe Decoction


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qi deficiency and blood stasis<br>Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine. | Drug: Anti-Platelet Drugs<br>* Including aspirin and clopidogrel, etc<br>Drug: Lipid Regulating Drugs<br>* Mainly including statins<br>Drug: Coronary Vasodilator<br>* Mainly including nitrates<br>Drug: Shuanghe Decoction<br>* Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.<br>|
| Other: Conventional western medicine<br>Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc. | Drug: Anti-Platelet Drugs<br>* Including aspirin and clopidogrel, etc<br>Drug: Lipid Regulating Drugs<br>* Mainly including statins<br>Drug: Coronary Vasodilator<br>* Mainly including nitrates<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unstable Angina, Shuanghe Decoction