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Randomized, double-blind, placebo-controlled clinical study of Jiaweiyixin Decoction in the treatment of Qi deficiency and blood stasis syndrome of chronic heart failure

Randomized, double-blind, placebo-controlled clinical study of Jiaweiyixin Decoction in the treatment of Qi deficiency and blood stasis syndrome of chronic heart failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000203
Enrollment
Unknown
Registered
2024-08-09
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

chronic cardiac failure

Interventions

Control group:On the basis of conventional western medicine treatment, after 0.5h interval with western medicine, take 1 bag of Jiawei Yixin Tang granule simulator with warm water/time, orally divided
Experimental group:On the basis of conventional western medicine treatment, Jiawei Yixin Tang granules were taken with warm water 1 bag/time after 0.5h interval with Western medicine, orally divided i

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the above Western diagnostic standards and TCM syndrome differentiation standards; 2. NYHA cardiac function Grade ? and ?; 3. The primary disease was coronary heart disease and dilated cardiomyopathy. 4, aged between 65 and 80 years old; 5. Did not participate in other drug clinical studies within 1 month before inclusion; 6. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Heart failure after acute myocardial infarction; 2. EF > 50%; 3. Increased mortality associated with cardiogenic shock, severe ventricular arrhythmia, complete atrioventricular block, constrictive pericarditis, pericardial tamponade, pulmonary embolism, etc.; 4. Patients with severe primary diseases such as liver, kidney, hematopoietic system, abnormal kidney function, and severe mental illness; 5, uncontrolled infection, hypertension, etc.; 6. Allergy or known allergy to therapeutic drugs.

Design outcomes

Primary

MeasureTime frame
Minnesota Quality of Life in Cardiac Insufficiency Questionnaire(MLFHQ);

Secondary

MeasureTime frame
Serum NT-proBNP, interleukin-6, tumor necrosis factor-a levels;Cardiovascular endpoint events were followed up for 12 months after the end of treatment;Hamilton Anxiety Scale(HAMA);TCM syndromes of chronic heart failure;The six-minute walk test(6-MWT);Left ventricular ejection fraction (EF), cardiac output (CO);

Countries

China

Contacts

Public ContactLu Xiaohui

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

zhangyutcm@163.com+86 136 6880 8785

Outcome results

None listed

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