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Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure: A Multicenter, Randomized, Double Blinding, Parallel Placebo-Controlled Trial

Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure: A Multicenter, Randomized, Double Blinding, Parallel Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001478
Enrollment
Unknown
Registered
2011-08-13
Start date
2011-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure

Interventions

B:Standard treatment of CHF + placebo Capsule 4 granules t.i.d., po for 12 wks.
A:Standard treatment of CHF + Qili Qiangxin Capsule 4 granules t.i.d., po for 12 wks.

Sponsors

The First Hospital Affiliated to Nanjing Medical University, People's hospital of Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged 18-75; 2. Voluntarily signed the informed consent and having good adherence; 3. Patients with history or clinical symptoms of chronic heart failure (CHF) more than 3 months; 4. Left ventricle eject fraction =450pg/ml; 7. Patients have received standard medical treatment for more than 2 wks and no modification of dosage or intravenous administration has been given.

Exclusion criteria

Exclusion criteria: 1. CHF is caused by following condition: valvular disease, congenital heart disease, pericardial disease, cardiac arrhythmia, or other non-cardiogenic factors, including dysfunction of kidney, liver and lung. Acute heart failure or HF after acute myocardial infarction; 2. Patients with plan of the coronary revascularization or resynchronization in 12 wks. Patients who have received cardiac resynchronization; 3. Patients with severe liver, kidney, hematological disease or abnormal renal or hepatic funtion (ALT and ALP > 1.5 UNL, Cr> 194.5umol/L), serum potassium >5.5 mmol/L. Patients with tumor, severe neural, endocrine or psychological disease; 4. Patients with left ventricular outflow tract obstruction, myocarditis, large aneurysm, dissecting aneurysm, congenital heart disease or unfixed valvular disease that causes predominated hemodynamic change; 5. Patients with cardiac shock, uncontrolled malignant arrhythmia, II or severer SAB and AVB without pacemaker, progressive unstable agina pectoris and AMI; 6. Uncontrolled hypertension: systolic pressure >= 180 mmHg and/or diastolic >=110 mmHg; systolic pressure <= 90 mmHg and/or diastolic <=60 mmHg; 7. Patients were enrolled in other trial within last month; 8. Pregnant or lactating women; 9. Allergic to the trial medicine; 10. Other conditions that make patients cannot follow the trial requirements.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;composite event;

Secondary

MeasureTime frame
6 minute walking test;NYHA classification;LVEF and LVED;Minnesota living with heart failure questionnaire;Change of NT-proBN;

Countries

China

Contacts

Public ContactRunlin Gao, Boli Zhang, Jun Huang
jsphkj@163.com+86 25 68136360

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026