Status:
COMPLETED
Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery
Lead Sponsor:
Shanghai Hutchison Pharmaceuticals Limited
Collaborating Sponsors:
Shanghai Changzheng Hospital
The Second People's Hospital Of Bengbu
Conditions:
Ischemia With Non-Obstructive Coronary Artery
Angina Pectoris
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 pi...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04897126
Start Date
May 11 2021
End Date
October 25 2023
Last Update
April 23 2024
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003