Compound Danshen Dripping Pill for Diabetic Microvascular Angina
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Danshen Dripping Pill, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Microvascular Angina. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Compound Danshen Dripping Pill in Patients With Diabetic Microvascular Angina
Overview
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
- Drug Danshen Dripping Pill
Danshen Dripping Pill, 10 pills once, three times a day - Drug Placebo
Placebo, 10 pills once, three times a day
Primary outcome measures
- Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up [Time frame: From baseline to the end of 12-month treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Qilu Hospital of Shandong University — Jinan
- Central Hospital Affiliated to Shandong First Medical University — Jinan
- The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianf — Jinan
Identifiers
NCT: NCT06727890 · CDDP for CMVD