Traditional Chinese Medicine for Treatment of Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT01939236|
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : October 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Drug: traditional Chinese medicine Drug: Placebo (gummeline)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Experimental: traditional Chinese medicine
Subjects were treated with TCM 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient with chronic heart failure is qi deficiency and blood stasis. He will take drug of qi deficiency and blood stasis 2 times per day for 28 days.
Drug: traditional Chinese medicine
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 Comparator: placebo (gummeline)
Subjects were treated with placebo 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient with chronic heart failure is qi deficiency and blood stasis. He will take drug of qi deficiency and blood stasis 2 times per day for 28 days.
Drug: Placebo (gummeline)
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.
- Left ventricular ejection fraction [ Time Frame: 14 days, 28 days ]The level of left ventricular ejection fraction was detected with the modified Simpson's rule at baseline and 28 days.
- Traditional Chinese medicine syndrome scores (TCM-SS) [ Time Frame: 14 days, 28 days ]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.
- New York Heart Association (NYHA) functional classification [ Time Frame: 14 days, 28 days ]
- 6-minute walk test (6MWT) [ Time Frame: 14 days, 28 days ]6MWT was took according to the guidelines for the 6MWT promulgated by the American Thoracic Society at baseline and 28 days after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939236
|Beijing University of Chinese Medicine|
|Beijing, Beijing, China, 100029|
|Study Chair:||Wei Wang, Doctor||Beijing University of Chinese Medicine|
|Principal Investigator:||Peng Zhang, Doctor||Wuhan Hospital of Chinese Medicine|
|Study Director:||Huihui Zhao, Doctor||Beijing University of Chinese Medicine|
|Principal Investigator:||Liangtao Luo, Master||Beijing University of Chinese Medicine|