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A Randomized Controlled Trial of Xinhuosu Combined with Shenfu Injection for the Treatment of Wet-Cold Type Acute Heart Failure

A Randomized Controlled Trial of Xinhuosu Combined with Shenfu Injection for the Treatment of Wet-Cold Type Acute Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002423
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Acute Heart Failure

Interventions

Control Group:Xinhuosu + Standard treatment
Treatment group:Xinhuosu + Standard treatment + Shenfu injection

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 85 years old; 2. Confirmed patients with wet-cold type AHF, and cardiac function classification (NYHA classification) of Class III to IV; 3. The individual or their legal guardian has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Significantly increased risk of hypotension (persistent systolic blood pressure <90 mmHg); 2. Presence of significant valvular stenosis, hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, or cardiac tamponade; 3. Severe hepatic or renal dysfunction, Child-Pugh class C, or creatinine clearance <30 ml/min; 4. Pregnancy, lactation, or plans to conceive within the next 3 months; 5. Suspected allergy to the investigational product or its components; 6. Patients who have participated in other clinical studies within the past 3 months.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;

Secondary

MeasureTime frame
Mean Arterial Pressure;Stroke volume;Cardiac Index;Arterial blood lactate;Left ventricular end-diastolic diameter;Left ventricular end-systolic diameter;Left ventricular ejection fraction;New York Heart Association (NYHA) Classification;Time to relief of dyspnea symptoms;Cumulative Fluid Balance;C-reactive protein;Interleukin-6;Tumor Necrosis Factor-alpha;Traditional Chinese Medicine Syndrome Score;

Countries

China

Contacts

Public ContactXiao Lu

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Xljhy1987@126.com13920364752

Outcome results

None listed

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