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A Clinical Evaluation Study of Optimized New Shengmai Powder in the Treatment of Chronic Heart Failure

A Randomized, Double-blind, Placebo-controlled Clinical Trial of Optimized New Shengmai Powder in the Treatment of Chronic Heart Failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083060
Enrollment
Unknown
Registered
2024-04-15
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-04-22

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:Standardized Western medicine treatment combined with Optimized New Shengmai Powder

Sponsors

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

Eligibility

Sex/Gender
All
Age
35 Years to 79 Years

Inclusion criteria

Inclusion criteria: (1) Age from 35 to 79 (including boundary value), gender not limited; (2) Diagnosed as chronic heart failure according to the western medicine criteria; (3) Grade II to III (NYHA cardiac functional classification); (4) Complying with the TCM syndrome differentiation standard of qi deficiency, blood stasis with water retention; (5) No Chinese medicine taken within 2 weeks; (6) Informed consent signed.

Exclusion criteria

Exclusion criteria: (1) Acute heart failure; (2) Those who have one of the following diseases: Acute coronary syndrome within 30 days; revascularization therapy within 6 months; uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg; second-degree type 2 or worse sinoatrial /atrioventricular block without implantation of a pacemaker or uncontrolled malignant cardiac arrhythmia; hypertrophic obstructive cardiomyopathy; myocarditis; pulmonary artery embolism; severe valvular heart disease; pulmonary heart disease; stroke within 6 months; (3) Individuals who are unable to undergo cardiopulmonary exercise tests due to physical disabilities or other reasons; (4) Individuals with severe endocrine disorders such as hyperthyroidism, severe anemia (hemoglobin = 9g/dl), or other diseases that affect survival (such as malignant tumors); (5) Patients with abnormal liver and kidney function (Alanine aminotransferase (ALT) and/or serum creatinine > 2 times the upper limit of normal); (6) Suspicious or definite allergy to intervention drugs; (7) Participated in other trials within 2 months; (8) Being pregnant, planning for pregnancy or breastfeeding; (9) Evaluated to be unsuitable to participate in the study by the researcher.

Design outcomes

Primary

MeasureTime frame
6-minute walking distance;Peak oxygen consumption;

Secondary

MeasureTime frame
MLHFQ score;MLHFQ in the principle of Chinese civilization and traditional medicine characteristics score;Information scoring of four diagnostic methods in TCM;New York Heart Association (NYHA) cardiac functional classification;Echocardiography indexes;BNP;

Countries

China

Contacts

Public ContactXianliang Wang

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

xlwang1981@126.com+86 139 2000 7825

Outcome results

None listed

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