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Discussion on the clinical efficacy and mechanism of action of Yang Qi Huo Xue Pill in the treatment of acute decompensated heart failure of Qi deficiency and blood stasis type

Discussion on the clinical efficacy and mechanism of action of Yang Qi Huo Xue Pill in the treatment of acute decompensated heart failure of Qi deficiency and blood stasis type

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001570
Enrollment
Unknown
Registered
2025-08-19
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Acute decompensated heart failure

Interventions

control subjects:The control group received conventional Western medicine treatment in accordance with the *Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018* , which primarily
2) Elimination of risk and precipitating factors, such as infection control, correction of electrolyte imbalances, management of arrhythmias, and treatment of anemia
3) Management of underlying comorbidities: patients with concurrent conditions such as atrial fibrillation, hypertension, type 2 diabetes, or coronary atherosclerotic heart disease received standardiz
4) Standard pharmacotherapy, consisting of: ACEI/ARNI (ARNI therapy utilized sacubitril-valsartan sodium tablets [brand name: Entresto], initiated at 50 mg twice daily and up-titrated as tolerated, wi
ß-blockers (extended-release metoprolol succinate [brand name: Betaloc], initiated at 23.75 mg once daily and doubled every two weeks if tolerated, with a maximum long-term maintenance dose not exceed
aldosterone receptor antagonists (spironolactone tablets) and diuretics (furosemide tablets) (dosage adjustments based on heart rate, blood pressure, urine output, etc.)
and sodium-glucose cotransporter-2 inhibitors (dapagliflozin tablets, 5 mg/tablet, with dosage adjustments based on blood pressure, body weight, volume status, blood glucose, and renal function).
YQHXP Group:I

Sponsors

Wuxi Hospital Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) age 18-85 years; (2) meet the diagnostic criteria for ADHF in Western medicine; (3) meet the diagnostic criteria for ADHF in the form of qi deficiency and blood stasis in Chinese medicine; (4) New York Heart Association (NYHA) cardiac function class II-IV; (5) be able to perform echocardiograms and walk a distance of 6 min (6-MWD); (6) have no mental disorders and be able to cooperate with the investigation; (7) have not participated in any other medical research in the last 2 months; (8) voluntarily participate in the present study and sign informed consent; (9) good compliance and ability to adhere to the follow-up.

Exclusion criteria

Exclusion criteria: (1) implanted within 12 weeks of cardioverter defibrillator or cardiac resynchronisation therapy; (2) combined with acute coronary syndrome (within 30d), cardiogenic shock, acute myocarditis, uncontrollable malignant arrhythmia, hypertrophic obstructive cardiomyopathy, pericarditis, pericardial tamponade, severe valvular disease requiring surgical treatment, and pulmonary artery embolism, etc.; hyperthyroidism, anaemia, severe pulmonary arterial hypertension, heart failure caused by hyperthyroidism, anaemia, severe pulmonary hypertension, congenital heart disease, etc.; (3) combined heart, liver, kidney, haematopoietic, metabolic system, and other serious primary diseases, malignant tumours, jaundice, liver and renal insufficiency; (4) combined with acute infections; (5) positive antibodies to human immunodeficiency virus (HIV), positive syphilis, hepatitis B and C patients; (6) aggravation of the symptoms of heart failure due to digitalis poisoning; (7) pregnant, gestating, or breastfeeding women; (8) suspected or confirmed alcohol or drug abusers; (9) allergic or allergic to more than 2 kinds of food or drugs, or allergic to the test drug and its raw materials; (10) participants in other studies within the past 2 months.

Design outcomes

Primary

MeasureTime frame
B-cell lymphoma 2;N-terminal B-type natriuretic peptide principle;vascular endothelial growth factor;Human hypoxia-inducible factor 1a;

Secondary

MeasureTime frame
left ventricular ejection fraction;Traditional Chinese Medicine (TCM) Symptoms;Cardiac Function Classification;Incidence of adverse cardiovascular events (MACE) at 3-month follow-up;Chinese Medicine Symptom Score;6 minute walk;

Countries

China

Contacts

Public Contactyao yiming

Wuxi Hospital Nanjing University of Chinese Medicine

yaoyiming222@163.com13601517367

Outcome results

None listed

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