Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
N/A
Details
Lead Sponsor:
State Administration of Traditional Chinese Medicine of the People's Republic of China