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Qishenyiqi Dripping Pill for Coronary Microvascular Disease (CMVD)

S

Shandong University

Status and phase

Enrolling
Phase 4

Conditions

Coronary Microvascular Disease

Treatments

Drug: Qishenyiqi dripping pills 1 bag, three times a day
Drug: Placebo 1 bag, three times a day

Study type

Interventional

Funder types

Other

Identifiers

NCT06699420
Qishenyiqi for CMVD

Details and patient eligibility

About

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.

Enrollment

162 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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;
  • Subjects or their guardians agreed to participate in this study.

Exclusion criteria

  • 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;
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

162 participants in 2 patient groups, including a placebo group

Qishenyiqi Dripping Pill
Experimental group
Treatment:
Drug: Qishenyiqi dripping pills 1 bag, three times a day
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo 1 bag, three times a day

Trial contacts and locations

3

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Central trial contact

Panpan Hao, Dr.

Data sourced from clinicaltrials.gov

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