Chronic heart failure
Conditions
Interventions
Experimental group:Qishen Yiqi Dripping Pills 1 bag at a time 3 times a day 12 weeks
,GMDT standard medication
Experimental group:Placebo 1 bag at a time 3 times a day 12 weeks
GMDT standard medication
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for chronic heart failure; (2) Meet the TCM criteria for syndrome differentiation of qi deficiency and blood stasis syndrome in chronic heart failure; (3)18y=age=80ygender is not limited; (4) left ventricular ejection fraction (LVEF) <50% (modified Simpson method); (5) NYHA Cardiac Function Class II.-III; (6) Those who have received standardized drug therapy for chronic heart failure at least 2 weeks before randomization and the dose has not been adjusted within 2 weeks and intravenous therapy (vasoactive drugs diuretics) has not been given; (7) Fully understand the purpose of the study and voluntarily sign the informed consent form; (8) Able to use effective contraceptive measures and have no need to have children during the trial; (9) As judged by the investigator be able to comply with the trial protocol and cooperate with the data collection.
Exclusion criteria
Exclusion criteria: (1) NYHA Cardiac Function Class IV; (2)Concomitant uncontrolled grade III hypertension (Systolic blood pressure=180mmHg and/or Diastolic blood pressure =110mmHg)patients with severe cardiopulmonary insufficiency severe arrhythmia serious primary diseases such as liver kidney and hematopoietic system or severe diseases (such as tumors etc.) and mental illness that affect their survival. (3) Combined with other clinical conditions that may lead to an increased risk of bleeding such as a history of bleeding from important organs (such as cerebral hemorrhage upper gastrointestinal bleeding etc.) in the past six months decreased platelet count abnormal coagulation function and oral warfarin anticoagulation therapy. (4) Patients with abnormal liver and kidney function indicators( ALTASTScr 2 times above the upper limit of the normal reference range). (5) Patients with allergies or allergies to multiple drugs and foods or patients with known allergies to the test drugs (including their components). (6) Patients who cannot complete the CPET test due to joint and other related diseases. (7) Those who have a pregnancy plan or pregnant or lactating women. (8) Patients who participated in other clinical trials within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VO2/Kg AT; | — |
Secondary
| Measure | Time frame |
|---|---|
| RER max;TCM Syndrome Points;RER AT;Clinical signs/symptoms;?VO2/?WR;Grip strength body mass index test;VE/VCO2;VO2/Kg max;Liver function;W AT;Met AT;NYHA Cardiac Function Classification;Met max;HR max;Minnesota Heart Failure Quality of Life Scale score;W max;O2 Pulse;HRR-n;HR AT; | — |
Countries
China
Contacts
Public ContactYeTao-Chun
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed