Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-01

Brief Summary

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A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.

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Detailed Description

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Conditions

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Stable Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double mind

Study Groups

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Zhenyuan capsule

Group Type EXPERIMENTAL

Zhenyuan capsule

Intervention Type DRUG

0.25g/ tablets, 2 tablets / TID, for 12 weeks

Zhenyuan capsule placebo

Group Type PLACEBO_COMPARATOR

Zhenyuan capsule

Intervention Type DRUG

0.25g/ tablets, 2 tablets / TID, for 12 weeks

Interventions

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Zhenyuan capsule

0.25g/ tablets, 2 tablets / TID, for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
* LVEF≥40%；
* Angina grade Ⅰ-Ⅱ (CCS grade);
* The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
* 18 years old ≤ age ≤ 75 years old；
* In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
* Those who sign the informed consent form.

Exclusion Criteria

* Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
* Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
* Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
* Renal insufficiency, serum creatinine \> 2.5mg / dl in male and \> 2.0mg/dl in female；
* Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
* New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
* Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
* Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
* Pregnant or preparing pregnant women, lactating women;
* Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
* For those who are allergic to the known ingredients of the drug.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No