Diabetic Microvascular Angina
Conditions
Brief summary
To investigate the efficacy and safety of Compound Danshen Dripping Pill in patients with diabetic microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Compound Danshen Dripping Pill on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.
Interventions
Danshen Dripping Pill, 10 pills once, three times a day
DRUGPlacebo
Placebo, 10 pills once, three times a day
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
History of type 2 diabetes ≧5 years; Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis \<50%; Ischemic depression in ST segment during resting or exercise; Coronary flow reserve (CFR) of the anterior descending coronary artery \< 2.0, or CFR ≧2.0 but acetylcholine activation test is positive; Subjects or their guardians agreed to participate in this study.
Exclusion criteria
Previous myocardial infarction or PCI or CABG treatment; Severe arrhythmia; Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Allergic to contrast agents or traditional Chinese medicines; Patients who participated in clinical research of other drugs within 3 months before being selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up | From baseline to the end of 12-month treatment |
Countries
China
Contacts
Primary ContactPanpan Hao, MD, PhD
Outcome results
None listed