A study on the efficacy and safety of Shexiang Baoxin Pill in patients with chest pain due to non obstructive coronary artery disease

Phase 4

Recruiting

• Conditions: on obstructive coronary artery disease

• Registration Number: ITMCTR2100004634
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18~75 years, gender is not limited.
2. Clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), and coronary CTA or coronary angiography imaging examination of normal coronary artery or major vascular branches of the largest lesion < 50%;
3. Willing to follow up and sign informed consent.

Exclusion Criteria

1. There was no angina pectoris without medication;
2. Coronary CTA or coronary angiography examination showed that the largest lesion of major vascular branches was more than or equal to 50%;
3. Severe cardiopulmonary vascular diseases: intractable heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, insufficiency, aortic dissection, pulmonary embolism;
4. Patients with acute myocardial infarction within 3 months;
5. Severe respiratory diseases, COPD or active pulmonary infection;
6. The patients with poor blood pressure control received hypertension treatment, but before the end of the screening period, the hypertension was not controlled and / or the systolic blood pressure was >= 180mmhg and / or the diastolic blood pressure was >= 110mmhg;
7. 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, liver cirrhosis or uremia;
8. Any other serious disease or condition, such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety and depression (HAMD-17) and even suicide or manic mental illness;
Participated in other clinical studies within 30 days before enrollment;
10. Pregnant and lactating women and women and men with recent family planning;
11. Allergic constitution or allergy to known components of the study drug;
12. Patients judged by the researcher as unsuitable for the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the changes of Seattle angina pectoris scale;

Secondary Outcome Measures

Name	Time	Method
Pharmacoeconomic evaluation;the changes of SAQ scores ;the incidence of major cardiovascular events (MACE);the changes of total dosage of sublingual nitroglycerin buccal tablets;the average number of angina attacks per week;the changes of CCS angina pectoris grading ;