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

Primary Purpose

Stable Coronary Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zhenyuan capsule
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Coronary Heart Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zhenyuan capsule

Zhenyuan capsule placebo

Arm Description

Outcomes

Primary Outcome Measures

Cardiopulmonary function index change
Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
June 4, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04421287
Brief Title
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD
Official Title
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double mind
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zhenyuan capsule
Arm Type
Experimental
Arm Title
Zhenyuan capsule placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zhenyuan capsule
Intervention Description
0.25g/ tablets, 2 tablets / TID, for 12 weeks
Primary Outcome Measure Information:
Title
Cardiopulmonary function index change
Description
Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；
Time Frame
Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NA HUAN, Master
Phone
0086
Ext
18353214796
Email
HUANNA0323@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long C Wang, doctorate
Organizational Affiliation
Xiyaun Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
long C Wang, doctorate
Phone
0086-010-6287
Ext
9814
Email
WCL796@163.com

12. IPD Sharing Statement

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

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