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Shenfu injection in the treatment of Coronary heart disease acute exacerbation of chronic heart failure (yangqi kuixu zheng), a multicenter randomized, blind, controlled trial

Shenfu injection in the treatment of Coronary heart disease acute exacerbation of chronic heart failure (yangqi kuixu zheng), a multicenter randomized, blind, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002857
Enrollment
Unknown
Registered
2012-12-25
Start date
2012-12-01
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

Coronary heart disease acute exacerbation of chronic heart failure

Interventions

Experimental:Basal therapy+Shenfu injection 50ml mix with 5% glucose injection 100ml intravenous infusion onece a day
control:Basal therapy+5% glucose injection 100ml intravenous infusion onece a day

Sponsors

The First Affiliated HospitaI of Tianjin University of TraditionaI Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Coronary heart disease acute exacerbation of chronic heart failure diagnostic standard; 2. 40~79 years of age; 3. The NYHA grade for heart failure should be III~IV; 4. Signed the inform consent.

Exclusion criteria

Exclusion criteria: 1. Acute coronary syndrome, onset of acute myocardial infarction within past 6 months, revascularization whithin past six months, or plan to revasculariation in the near future, cardioc shock, fatal arrhythmia, Cardiomyopathy, Constrictive pericarditis, Pulmonary embolism, etc.; 2. Severe liver, renel disfunction (ALT higher than the normal value three folders, and Cr>=3mg/dL; 3. Complicated with endocrine system, blood system severe original diseases; 4. Woman plan to pregnance in followed three months, or lactating women; 5. Mental disease patient; 6. Allergic constitution, or known allergy for the test drug; 7. Attended other clinical studies in past three months; 8. To be judged that the patient unable to alive less than three months; 9. To be judged the patient cannot complete the study or do not complain the rule of this study.

Design outcomes

Primary

MeasureTime frame
NYHA;TCM symptom scores;

Secondary

MeasureTime frame
echocardiogram examination;NA;Lee's Heart failure score;6-minute walk test;Cardiovascular events, Re-hospitalization rate;

Countries

China

Contacts

Public ContactMao Jingyuan
jymao@126.com+86 13820498886

Outcome results

None listed

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