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To evaluate the effectiveness and safety of Xinyang Tablets in the treatment of chronic heart failure (Qi Yang deficiency, blood stasis, and water stop)

To evaluate the effectiveness and safety of Xinyang Tablets in the treatment of chronic heart failure (Qi Yang deficiency, blood stasis, and water stop)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051490
Enrollment
Unknown
Registered
2021-09-24
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Chronic heart failure

Interventions

Experimental group:Xinyang Pian
Control group:Xinyang tablet mimic medicine

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Have a history of chronic heart failure for more than 3 months or have clinical symptoms of heart failure for more than 3 months. The diagnosis of chronic heart failure should refer to the "2018 Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in China" issued by the Chinese Society of Cardiovascular Medicine. ; 2. Aged 18 to 80 years; 3. Cardiac function class II-IV (NYHA), left ventricular ejection fraction = 450pg/ml; 4. Those who meet the syndrome differentiation criteria of TCM deficiency of qi and yang, blood stasis and water stasis; 5. Those who have received at least 2 weeks of conventional drug therapy with fixed doses of western medicine, and have not been given vasoactive drugs or diuretics for intravenous therapy; 6. Those who have not used traditional Chinese medicine for the treatment of heart failure within 2 weeks before enrollment; 7. Those who participated voluntarily, understood and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute cardiac insufficiency. 2. Those who undergo coronary revascularization and cardiac resynchronization therapy within 12 weeks, or those who plan to undergo cardiac resynchronization therapy within 12 weeks; 3. Accompanied by cardiogenic shock, or fatal arrhythmia, type II or higher sinoatrial or atrioventricular block, obstructive cardiomyopathy, restrictive cardiomyopathy, pulmonary heart disease disease, congenital heart disease, significant hemodynamic changes in patients with unrepaired valvular heart disease, large aneurysm, dissecting aneurysm, constrictive pericarditis, myocarditis, cardiac tamponade, pulmonary embolism, progressively worsening unstable angina or acute Patients with myocardial infarction, and other diseases that affect the efficacy and safety of drugs for heart failure. 4. Combined with severe lung, liver and kidney dysfunction, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum creatinine exceeding 2 times the upper limit of normal, serum potassium > 5.5mmol/L; endocrine system, hematopoietic system and other serious factors onset disease. 5. Patients with uncontrolled hypertension, systolic blood pressure >=180/mmHg and/or diastolic blood pressure >=110mmHg; systolic blood pressure <90mmHg and/or diastolic blood pressure <60mmHg; 6. Pregnant or lactating women. 7. Cancer patients, combined with mental illness, or unwilling to cooperate. 8. Participated in clinical investigators of other drugs within 1 month. 9. The researcher believes that it is not suitable to participate in the research.

Design outcomes

Primary

MeasureTime frame
NT-pro BNP;6-minute walking distance;

Secondary

MeasureTime frame
Cardiac function classification;Traditional Chinese Medicine syndrome score;Echocardiography;Minnesota Heart Failure Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactXian Shaoxiang

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

ljh833@163.com+86 18826062651

Outcome results

None listed

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