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Clinical trial investigating the efficacy of Guanxin formula in managing coronary microvascular disease among perimenopausal women

Clinical trial investigating the efficacy of Guanxin formula in managing coronary microvascular disease among perimenopausal women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002125
Enrollment
Unknown
Registered
2025-11-08
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

coronary microvascular disease among perimenopausal women

Interventions

Control group:Conventional basic therapy (antiplatelet aggregation, lipid regulation, stabilization of atherosclerotic plaques, etc., such as beta-blockers, statins, ivabradine, etc.)
Experimental group:Conventional basic therapy (such as antiplatelet aggregation lipid regulation and plaque stabilization including ß-blockers statins ivabradine etc.) plus Guanxin formula herbal gra

Sponsors

The Eighth Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Perimenopausal women aged 40-60 years; (2) Has typical labor-induced angina symptoms; (3) Meets the diagnostic criteria for TCM phlegm syndrome; (4) Coronary CTA or contrast examination shows normal coronary arteries or stenosis <50% or residual coronary stenosis <50% after revascularization; (5) Coronary flow reserve (CFR) < 2.5 as assessed by transthoracic ultrasound examination of the anterior descending branch blood flow reserve before and after intravenous adenosine administration; (6) The patient has given informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Age less than 40 years old or greater than 60 years old; (2) History of carotid endarterectomy or stent implantation history of stroke; (3) Myocarditis pericardial disease valve disease cardiomyopathy; (4) Uncontrolled diabetes (fasting blood glucose > 7.0 mmol/L); (5) Difficult-to-control hypertension (SBP > 150 mmHg and/or DBP > 90 mmHg); (6) Familial hypercholesterolemia; (7) Polyarteritis nodosa; (8) Abnormal liver function (serum GPT level more than 3.0 times the upper limit of normal) or abnormal kidney function (serum creatinine level more than 2 mg/dl); (9) Other clinically significant respiratory digestive hematologic infectious immunologic endocrine neurologic psychiatric and oncologic diseases that may pose a serious risk to patients; (10) Patients requiring warfarin anticoagulation therapy; Chinese herbal preparations that act as K channel openers and improve microcirculation; (11) Patients allergic to intravascular administration of contrast media blood or blood products; (12) Patients who are currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Difference in coronary left anterior descending artery blood flow reserve (CFR) measured by ultrasound;Cardiac output;Six-minute walk test;

Secondary

MeasureTime frame
Number of angina attacks per week;Blood lipid levels;Six sex hormones;Vascular endothelial function indicators;Seattle Angina Scale;Menopause Quality of Life Scale;Syndrome-related indicators;TCM Syndrome Score;Other security indicators;

Countries

China

Contacts

Public ContactPeng sihan

The Eighth Affiliated Hospital Sun Yat-sen University

1766566251@qq.com+86 137 6011 0223

Outcome results

None listed

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