Health TrialsbyHealthPanel

Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged ≥ 18 years and ≤80 years when signing the informed consent form.

Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure.

Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis.

NYHA Functional Classification Ⅱ-Ⅲ.

Disqualifiers

Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors related to hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy), valve and cardiac structure abnormalities (moderate or above aortic valve stenosis, other severely narrowed or incompetent heart valves, congenital heart disease), constrictive pericarditis, moderate or large pericardial effusion.

Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, kidney diseases, liver diseases, cardiac toxic injury (cardiotoxic drugs such as anti-tumor drugs, alcoholic cardiomyopathy).

Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization [percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)] treatment, undergone left ventricular assist device [cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD), etc.] treatment, undergone cardiac surgery (left ventricular reconstruction, heart transplantation, etc.) treatment, had acute cerebrovascular events (acute ischemic stroke, cerebral hemorrhage, transient ischemic attack).

Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during the trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Qishen Yiqi Dripping Pills 2 bags

    Drug

    Qishen Yiqi Dripping Pills contain Qishen Yiqi Dripping Pills 2 bags(0.52g dripping pills per bag), take orally half an hour after meals, 3 times a day for 12 weeks

  • Qishen Yiqi Dripping Pills placebo 2 bags

    Drug

    Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi Dripping Pills placebo 2 bags(0.52g dripping pills placebo per bag), take orally half an hour after meals, 3 times a day for 12 weeks

Treatment groups

636 Participants
are divided into 2 treatment groups
Group A: Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a dayExperimental treatment 1 intervention
Group B: Qishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a dayPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity).

Time frame
At baseline and at week 12.

Secondary outcomes

1

Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8.

Time frame
At baseline and at week 4 and week 8.
2

Change From Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Lower Quality of Life).

Time frame
At baseline and at week 4, week 8 and week 12.
3

The Disappearance Rate of Heart Failure Symptoms (shortness of breath, fatigue, edema) at Week 4, Week 8 and Week 12.

Time frame
At baseline and at week 4, week 8 and week 12.
4

Change From Baseline in Traditional Chinese Medicine (TCM) Syndrome Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Sever TCM Syndrome).

Time frame
At baseline and at week 4, week 8 and week 12.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tasly Pharmaceutical Group Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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