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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28days.
Placebo of each syndrome differentiation has the same weight and smell as traditional Chinese medicine of corresponding syndrome differentiation. 1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28 days.
Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Left ventricular ejection fraction
The level of left ventricular ejection fraction was detected with the modified Simpson's rule at baseline and 28 days.
Time frame: 14 days, 28 days
Traditional Chinese medicine syndrome scores (TCM-SS)
Before the study, all investigators took standardized training and conformance testing. Syndrome differentiation and syndrome scores were took by 3 investigators together, and the results needed to obtain two or more investigators' consent. There were 65 clinical symptoms evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM symptoms scored as without 0; very light 1; light 2; medium 3; heavy 4; very heavy 5 points.
Time frame: 14 days, 28 days
New York Heart Association (NYHA) functional classification
Time frame: 14 days, 28 days
6-minute walk test (6MWT)
6MWT was took according to the guidelines for the 6MWT promulgated by the American Thoracic Society at baseline and 28 days after treatment.
Time frame: 14 days, 28 days
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