Chronic Heart Failure Clinical Trial
Official title:
Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial
The purpose of this study is to determine whether traditional Chinese medicine as complementary treatment is safe and effective in the treatment of chronic heart failure.
Heart failure (HF) can be defined as an abnormality of cardiac structure or function leading
to failure of heart to deliver oxygen at a rate commensurate with the requirements of the
metabolizing tissues, despite normal filling pressures (or only at the expense of increased
filling pressures). And according to the nature of the clinical presentation, HF is divided
into acute or chronic HF.
In 2003, a random sample survey of 15,518 urban or rural residents between 35 and 74 years
old was made in China: the prevalence rate of heart failure was 0.9%, and according to the
result, there was about 4,000,000 HF subjects in China.
In China, the integrative treatment of western and traditional Chinese medicine (TCM) for HF
is common and has been developed as a treatment model. TCM has been used in China and other
south and east Asia countries for thousands of years. Syndrome differentiation and treatment
variation are the basic principles in understanding and treatment of diseases. Investigators
would like to test the hypothesis that it is efficacy and safety for patients to take TCM
granules according to syndrome differentiation.
The specific aims for the study were to evaluate the efficacy and safety of TCM in treating
chronic heart failure (CHF).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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