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Study on the clinical effect and potential mechanism of Sheng-mai Jiu-xin Decoction on Chronic heart failure with qi-yin deficiency yang deficiency and blood stasis

Study on the clinical effect and potential mechanism of Sheng-mai Jiu-xin Decoction on Chronic heart failure with qi-yin deficiency yang deficiency and blood stasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001057
Enrollment
Unknown
Registered
2025-05-28
Start date
2024-04-23
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

heart failure

Interventions

Western medicine standard treatment group:It should be treated with conventional Western medicine, referring to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024, which main
2) Removal of risk and predisposing factors
3)Treatment of previous underlying diseases
4) Basic western drug therapy, including: ACEI/ARNI, ß-blockers, aldosterone receptor antagonists, diuretics, sodium-glucose co-transporter protein 2 inhibitors.
Chinese medicine intervention group:The Chinese medicine treatment group was treated for 8 weeks with Shengmai-Jiuxin Decoction on the basis of the standard treatment of western medicine, and the trea

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 old; 2: Patients with chronic heart failure who meet the diagnostic criteria of Western medicine and the diagnostic criteria of Chinese medicine meet the diagnostic criteria of Heart Failure Disease with Qi and Yin deficiency and Yang deficiency and blood stasis; 3: New York Heart Association (NYHA) cardiac function class II-IV; 4: Ability to perform echocardiography and 6-min walk test (6MWT); 5: Those without mental disorder and able to cooperate with the investigation; 6: Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1: Those who have implanted cardioverter-defibrillator or performed cardiac resynchronization therapy within 12 weeks 2: Combined acute coronary syndrome (within 30d) cardiogenic shock acute myocarditis difficult to control malignant arrhythmia hypertrophic obstructive cardiomyopathy constrictive pericarditis pericardial tamponade severe valvular disease requiring surgical intervention and pulmonary artery embolism etc.; hyperthyroidism anemia severe pulmonary hypertension congenital heart disease and other causes of heart failure; 3: Those with combined serious primary diseases of heart liver kidney hematopoietic and metabolic systems malignant tumors jaundice liver and kidney insufficiency; 4: Those with combined acute infections; 5: People with positive antibody of human immunodeficiency virus (HIV) people with positive syphilis test patients with hepatitis B and C; 6: Those with worsening heart failure symptoms caused by digitalis drug intoxication 7: Women who are planning to become pregnant pregnant or breastfeeding; 8: People with suspected or confirmed alcohol and drug abuse; 9: Allergic or allergic to more than 2 kinds of food or drugs or allergic to the test drug and its raw ingredients; 10: Those who have participated in other studies within the last 2 months.

Design outcomes

Primary

MeasureTime frame
New York Cardiac Function Classification;N-terminal pro-brain natriuretic peptide,NT-proBNP;

Secondary

MeasureTime frame
left ventricular ejection fraction;Serum electrolytes (potassium sodium chloride);Serum human AMP-activated Protein Kinase;Six-minute walk test;Serum human microtubule-associated protein 1 light chain 3 beta;3-month incidence of adverse cardiovascular events MACE;Traditional Chinese Medicine Syndrome Points;Serum human silencing regulatory protein 1;blood biochemistry (creatinine uric acid liver and kidney function blood glucose);

Countries

China

Contacts

Public ContactXinying Xu

Nanjing University of Chinese Traditional Medicine

960035724@qq.com13405589720

Outcome results

None listed

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