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A post-market revalue clinical trial of efficay and safety of shenmai Injetion in coronary artery disease with Chronic Heart Failure.

A Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel group designed Trial of Efficacy and Safety of Shenmai injection in coronary artery disease with Chronic Heart Failure.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003063
Enrollment
Unknown
Registered
2012-02-07
Start date
2011-10-11
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

Group A:Shenmai injection + basical treatment
Group B:Placebo+basical treatment

Sponsors

First Affiliated Hospital of Guangzhou University of chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic crateria of chronic heart failure, NYHA cardiac function Grade II-IV; 2. Meet the TCM differentiation criteria of symptoms and signs of "Qiyin liangxu Zheng"; 3. prior standard medicin treatment as outpatient for more than 1 months and condition was not well uncontrolled that need inpatient treatment; 4. Male or female patients aged 40-80 years; 5. patient were well informed and voluntarily given the witten informed consent.

Exclusion criteria

Exclusion criteria: 1. acute cardiac dysfunction; 2. heart failure caused by reasons other than coronary artery disease; 3. combined with cardiac shock, or fetal arhythmia, degree II type II or severer atrioventricular block(AVB), obstructive cardiomyopathy, unrepaired valvular heart disease,Constrictive pericardis, cardiac tamponade;pulmonary embolism; acute myocardial infarction; heart failure combined with uncontrolled infection (eligible when the infection was controlled and otherwise eligible), and other diseases which may confuse the evaluation of the efficacy and the saftey of the heart failure. 4. Symptoms get worse caused by digitalis toxication; 5. Patients with Serious liver, kidney disease, or hematopoietic system disease, LFT( ALT, AST) >80 u/L, renal disfunction, or psychosis mental disease patient; 6. Pregnancy or breast-feeding women; 7. Patients with severe diabetes; 8. Prior take part in other clinical studies in 1 month; 9. Known Allergic to the trial medicine; 10. Other conditions that the investigor thought should not participate the trial.

Design outcomes

Primary

MeasureTime frame
6 minites walking test;NYHA cardiac functional classification;TCM systoms and signs index;

Secondary

MeasureTime frame
Lee's pathological grade;SF-36 Health Survey Scales;Brain natriuretic peptide (BNP);Echocardiograph;

Countries

China

Contacts

Public ContactShaoxiang Xian
yang_zhongqi@163.com+86 20 36591127

Outcome results

None listed

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