Angina Pectoris, Coronary Heart Disease, Ischemia With Non-Obstructive Coronary Artery, X Syndrome, Angina
Conditions
Keywords
Shexiang Baoxin Pill, MUSKARDIA, patients with chest pain due to non obstructive coronary artery disease
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while the experimental group was treated with MUSK Pill 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up.
Interventions
RADIATIONShexiang Baoxin pill（MUSKARDIA）
On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.
RADIATIONPlacebo
On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.
Sponsors
Shanghai Changzheng Hospital
The Second People's Hospital Of Bengbu
The Second Affiliated Hospital of Jiaxing University
Zibo Municipal Hospital
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shanxi Cardiovascular Hospital
The First Hospital of Hebei Medical University
Tangshan Central Hospital
Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group
Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Shanghai Hutchison Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
1:1 stratified block random grouping according to the center
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The age was 18-75 years old, and the gender was not limited; * The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), Within 1 year, coronary CTA or coronary angiography examination of coronary artery normal or lesions \< 50%; * Willing to follow up and sign informed consent.
Exclusion criteria
* Patients were selected and had no angina pectoris without medication * History of vascular reconstruction within 6 months, CABG or PCI; * Preparation for CABG or PCI during the trial period * The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination; * Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism; * There were three months of acute myocardial infarction; * Severe respiratory disease, COPD or active pulmonary infection; * Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period; * Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr \> 1.5 times of normal value), active liver disease, cirrhosis or uremia patients; * Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness; * Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies; * Pregnant, lactating women and women and men with recent birth plans; * Allergic constitution or allergy to known components of the study drug; * The researchers judged that the patients who were not suitable for the study were not suitable. (Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Seattle angina pectoris scale | 12 weeks ± 1 week | Main evaluation indicators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average number of angina attacks per week | 12 weeks ± 1 week | Secondary evaluation index |
| Changes in total dosage of sublingual nitroglycerin buccal tablets | 12 weeks ± 1 week | Secondary evaluation index |
| Changes of angina pectoris classification in CCS | 12 weeks ± 1 week | Secondary evaluation index |
| Incidence of major cardiovascular events (MACE) | 12 weeks ± 1 week | Secondary evaluation index |
| the incremental cost-effectiveness ratio (ICER) was used as the evaluation index | 12 weeks ± 1 week | Pharmacoeconomic evaluation |
Countries
China
Outcome results
None listed