Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery
Phase 4
Completed
- Conditions
- Coronary Heart DiseaseAngina PectorisX Syndrome, AnginaIschemia With Non-Obstructive Coronary Artery
- Interventions
- Radiation: Shexiang Baoxin pill（MUSKARDIA）Radiation: Placebo
- Registration Number
- NCT04897126
- Lead Sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Shexiang Baoxin pill（MUSKARDIA） The experimental group was treated with Shexiang Baoxin pill（MUSKARDIA） (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up Placebo group Placebo The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.
- Primary Outcome Measures
Name Time Method Changes of Seattle angina pectoris scale 12 weeks ± 1 week Main evaluation indicators
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China