Clinical study for treatment of angina pectoris after coronary intervention with Kuanxiong Aerosol
- Conditions
- angina pectoris after coronary intervention
- Registration Number
- ITMCTR1900025297
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria for angina pectoris after coronary intervention (both meet the following two):
(1) Within 1 year after coronary intervention;
(2) angina;
2. angina pectoris 2 times a week or more;
3. Patients aged 18 to 85 years;
4. Chinese medicines for treating angina pectoris are not used, or are discontinued for 2 weeks or more; and the variety and dosage of anti-angina pectoris medicines are not incereased within 2 weeks (including: beta Receptor blockers, non-dihydropyridine calcium ion antagonists;except nitroglycerin tablets;
5. The patient is willing to follow up and sign an informed consent form.
1. Those who are allergic to the Kuanxiong Aerosol or the ingredients contained (asarone oil, sandalwood oil, galangal oil, eucalyptus oil, borneol);
2. Can't or don't want to sign an informed consent form;
3. Continued severe angina (CCS Level IV);
4. In the past, severe ST-segment depression occurred during exercise test level 1;
5. In the past, cardiac ultrasound examination revealed a left ventricular ejection fraction (LVEF) <30%; or refractory heart failure or cardiogenic shock;
6. Prepare for CABG or PCI during the trial;
7. Patients with diabetes who have poor glycemic control (glycated hemoglobin more than 8.0% within one month prior to the trial);
8. Stage IV of chronic kidney disease;
9. Patients with severe liver disease or liver dysfunction (ALT, AST or TBIL > 2 times the upper limit of normal reference);
10. Any other serious disease or condition such as a malignant tumor;
11. Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg)
12. Severe arrhythmia (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.)
13. Have participated in another clinical study within 30 days before the screening period or have received randomization of the study;
14. Pregnant women or women preparing to become pregnant;
15. The investigator judged that the patient was not eligible to participate in the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seattle Angina Questionnaire (SAQ);
- Secondary Outcome Measures
Name Time Method Symptom grading quantization table;SF-12 quality of life scale;visual analogue scale of chest pain;