Qishenyiqi Dripping Pill for Coronary Microvascular Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorQilu Hospital of Shandong University

About this trial

To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;

Coronary normal or stenosis < 20%;

Ischemic depression in ST segment during resting or exercise;

Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;

Disqualifiers

Previous myocardial infarction or PCI or CABG treatment;

A history of heart failure;

Severe arrhythmia;

Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Qishenyiqi dripping pills 1 bag, three times a day

    Drug

    Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

  • Placebo 1 bag, three times a day

    Drug

    Placebo, 1 bag once, three times a day, 12 months

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Qishenyiqi Dripping PillExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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