Skip to content

A randomized, double-blind controlled study of Kuoxinfang in the treatment on Deficiency of Both Qi and Yin combined Blood Stasis with Dilated Cardiomyopathy

A randomized, double-blind controlled study of Kuoxinfang in the treatment on Deficiency of Both Qi and Yin combined Blood Stasis with Dilated Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049536
Enrollment
Unknown
Registered
2021-08-02
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Dilated cardiomyopathy

Interventions

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria of Western medicine for dilated cardiomyopathy and the TCM syndrome diagnosis of qi-yin deficiency and blood stasis syndrome; 2. Cardiac function classification (NYHA) is II-IV; 3. Aged between 18 and 80 years old; 4. Left ventricular ejection fraction (LVEF) <= 45%; 5. Those who do not apply other drugs outside the regulations during the observation period, and who can adhere to the completion of the treatment and the detection of observation indicators; 6. Agree to participate in clinical trial observation, sign the informed consent form and indicate the date.

Exclusion criteria

Exclusion criteria: 1. Combined shock, severe arrhythmia, acute myocardial infarction, pulmonary infarction, infective endocarditis, cardiac tamponade, constrictive pericarditis, left ventricular outflow tract stenosis; 2. Patients with severe liver and kidney insufficiency, hyperthyroidism, hypothyroidism, anemia and electrolyte balance disorders; 3. Pregnant and lactating women; 4. Patients with a history of malignant tumor within 3 years, other clinically significant respiratory system, digestive system, blood system, immune system, mental disease or diseases that may cause serious danger to the patient, and the life expectancy is shorter than the duration of the trial; 5. Allergic constitution or allergy to common drugs; 6. Those who have participated in other Chinese medicine clinical researchers within 3 months or are currently taking other Chinese medicines who are unwilling to stop; 7. Combined with mental illness, or poor compliance with traditional Chinese medicine treatment.

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction ;

Secondary

MeasureTime frame
Traditional Chinese Medicine score;Clinical symptoms and cardiac function classification;Minnesota Heart Failure Quality of Life Questionnaire;Lee heart failure integral;6 minutes walking distance;left ventricular end diastolic volume;left ventricular end systolic volume;left ventricular mass;Fast filling peak of early left ventricular diastolic filling / late diastolic filling peak;brain natriuretic peptide;transforming growth factor-beta;

Countries

China

Contacts

Public ContactWu Qiong

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

wuqiong1203@126.com+86 18917047505

Outcome results

None listed

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