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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004634
Enrollment
Unknown
Registered
2021-03-26
Start date
2021-05-06
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non obstructive coronary artery disease

Interventions

experimental group:Shexiang Baoxin Pills were added on the basis of conventional treatment
control group:Placebo was added on the basis of conventional treatment

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the changes of Seattle angina pectoris scale;

Secondary

MeasureTime frame
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 ;

Countries

China

Contacts

Public ContactChun Liang

Shanghai Changzheng Hospital

chunliangliang@126.com+86 13801731588

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026