MedDataX Logo

the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

NCT ID: NCT03333499

Last Updated: 2017-11-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators set out to evaluate the effects of the traditional Chinese medicinal mixture under the brand name YangXinShi (YXS) on the prognosis in patients with chronic heart failure when it is combined with the optimal combination drug treatment of heart failure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the control group

YanXinShi placebo pills

Group Type PLACEBO_COMPARATOR

YanXinShi placebo pills

Intervention Type DRUG

participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure

YanXinShi group

YanXinShi pills

Group Type EXPERIMENTAL

YanXinShi pills

Intervention Type DRUG

participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure

Trimetazidine group

Trimetazidine pills

Group Type ACTIVE_COMPARATOR

Trimetazidine pills

Intervention Type DRUG

participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

YangXinShi and Trimetazidine group

YanXinShi and Trimetazidine pills

Group Type OTHER

YanXinShi and Trimetazidine pills

Intervention Type DRUG

participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YanXinShi placebo pills

participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure

Intervention Type DRUG

YanXinShi pills

participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure

Intervention Type DRUG

Trimetazidine pills

participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

Intervention Type DRUG

YanXinShi and Trimetazidine pills

participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
* patients classified as NYHA II-IV (New York Heart Association)

Exclusion Criteria

* with severe liver or renal dysfunction
* with severe systematic conditions such as infection, malignant hypertension etc.
* hemodynamic instability (arrhythmia, acute cardiac infarction, aortic dissection etc.)
* not cooperating due to psychomotor deficiency, or with contraindications for exercise testing
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dalian University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

qin yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Zhongshan Hospital of Dalian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

haoren wang, M.D., M.S.

Role: CONTACT

Phone: 08641162893507

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

qin yu, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

zsyy_xhs2017-10

Identifier Type: -

Identifier Source: org_study_id