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Clinical study of Shenshao tablet on improving exercise tolerance of patients with chronic ischemic heart failure (qi deficiency and blood stasis syndrome)

Clinical study of Shenshao tablet on improving exercise tolerance of patients with chronic ischemic heart failure (qi deficiency and blood stasis syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004280
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-03-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

chronic ischemic heart failure (qi deficiency and blood stasis syndrome)

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
35 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria of chronic ischemic heart failure, refer to "Chinese guidelines for the diagnosis and treatment of heart failure 2018": (1)Previous history of myocardial infarction; coronary angiography or CT angiography showed at least one major coronary artery branch stenosis > 50%. (2)LVEF < 50% or with symptoms / signs of heart failure. (3)Coronary artery disease is closely related to heart failure. 2. In accordance with the diagnostic criteria of qi deficiency and blood stasis syndrome, refer to the technical guidelines for clinical research of new traditional Chinese medicine in chronic heart failure: (1)Main symptoms: shortness of breath / wheezing, fatigue, palpitation. (2)Secondary symptoms: a.languid and lazy speech, easy to work; b. spontaneous sweating; c.low voice; d.dark complexion / lips. (3)Tongue vein: the tongue is dark (or with ecchymosis, ecchymosis or tortuous purplish vein under the tongue), the moss is thin and white, and the pulse is heavy, thin, astringent or ineffectual. 3. New York Heart Association (NYHA) cardiac function class II - IV; 4. The age ranged from 35 to 74 years; 5. Informed consent, volunteers.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic heart failure who need medical treatment in the near future; 2. Patients complicated with acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, hypertension (systolic blood pressure >= 180mmhg and / or diastolic blood pressure >= 110mmhg), malignant arrhythmia, hypertrophic obstructive cardiomyopathy, severe valvular disease requiring surgical treatment and pulmonary embolism, etc.; 3. Severe hepatic and renal insufficiency; 4. Severe anemia; 5. Psychopath; 6. Cancer patients; 7. Patients participating in drug clinical trials in recent months; 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Veterans Specific Activity Questionnaire (VSAQ);

Secondary

MeasureTime frame
BNP, NT-proBNP;ECG;major cardiovascular end point events;The Kansas city cardiomyopathy questionnaire (KCCQ);Traditional Chinese Medicine Syndrome Score;6 min walking distance test;NYHA cardiac function classification;cardiac ultrasound;TnI, TnT;CRP;AST, LDH, a-HBDH, CK, CK-MB;

Countries

China

Contacts

Public ContactLyu Shichao

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

372272027@qq.com+86 13920127740

Outcome results

None listed

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