An interventional study of Qishen Yiqi Dripping Pills and Qishen Yiqi dripping pills dummy in Ischemic Heart Failure, sponsored by State Administration of Traditional Chinese Medicine of the People's Republic of China. Status unknown at 33 sites in China. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2013-03-20.
Sponsored by State Administration of Traditional Chinese Medicine of the People's Republic of China · Not applicable, Interventional, and Treatment
CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into two groups (treatment and control group) by central randomization service. The treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three times a day in addition to standardized western medications. Whereas the control group will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in addition to standardized western medications. Efficacy indicators include primary indicator (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause death, emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function classification; Minnesota life quality scale; scores from the four traditional chinese medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride, high density cholesterol and low density cholesterol. Safety indicators include blood pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th, 12th month after recruitment. All patients will be followed up until the end of study (Refers to the 12th month of the last case recruited into the study).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 640 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →State Administration of Traditional Chinese Medicine of the People's Republic of China is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with ischemic heart failure：
Exclusion Criteria:
Those who have one of the following diseases:
Drug: Qishen Yiqi dripping pills dummy
Drug: Qishen Yiqi Dripping Pills
One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
6MWT distance
Time frame: 0 month
6MWT
Time frame: 3rd month
6MWT
Time frame: 6th month
Composite endpoint
all-cause death, frequency of emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.
Time frame: 1st,3rd,6th,9th,12th month
Brain natriuretic peptide (BNP)
Time frame: 0,6th month
Echocardiography
Time frame: 0,6th month
Cardiothoracic Ratio(CR)
Time frame: 0,6th month
Cardiac function classification, NYHA
Time frame: 0,1st,3rd,6th,9th,12th month
Minnesota life quality scale
Time frame: 0,1st,3rd,6th,9th,12th month
Scores from the four TCM diagnostic methods
Time frame: 0,1st,3rd,6th,9th,12th month
blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)
Time frame: 0,3rd,6thmonth
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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State Administration of Traditional Chinese Medicine of the People's Republic of China