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Yiqi Fumai Injection pulse with GDMT on improving exercise tolerance of patients with chronic heart failure(Qi-Yin deficiency syndrome):a single-center, randomized controlled, prospective trial

Yiqi Fumai Injection pulse with GDMT on improving exercise tolerance of patients with chronic heart failure(Qi-Yin deficiency syndrome) :a single-center, randomized controlled, prospective trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079378
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-03
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Chronic heart failure (Qi-Yin deficiency syndrome)

Interventions

experimental group:GDMTplus 5.2g Yiqi Fumai Lyophilized Injection in 5% GS or 0.9% NS injection 250ml,qd for 10days
control group:Guideline-directed medical therapy(GDMT) treatment

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. All the patients are in accordance with the diagnostic criteria of Qi-Yin deficiency syndrome of chronic heart failure; 2. Aged 18 to 90; 3. Cardiac function classification: New York Heart Association (NYHA) II to III; 4. The patient gives informed consent and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic heart failure who need medical treatment in the near future; 2. Patients complicated with acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, hypertension (systolic blood pressure >= 180mmhg and / or diastolic blood pressure >= 110mmhg), malignant arrhythmia, hypertrophic obstructive cardiomyopathy, severe valvular disease requiring surgical treatment and pulmonary embolism, etc; 3. Severe hepatic and renal insufficiency; 4. Severe anemia; 5. Psychopath; 6. Cancer patients; 7. Patients participating in drug clinical trials in recent months; 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Veterans Specific Activity Questionnaire (VSAQ);

Secondary

MeasureTime frame
New York Heart Association (NYHA) classification;Electrocardiogram(ECG);Ultrasonic Cardiogram(UCG);6 min walking distance test;BNP/ NT-proBNP;The Kansas city cardiomyopathy questionnaire (KCCQ);Syndrome rating Score;liver function(ALT,AST);renal function(CREA,BUN);

Countries

China

Contacts

Public ContactShichao Lv

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

dr_lv@foxmail.com+86 139 2012 7740

Outcome results

None listed

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