Traditional Chinese Medicine for Treatment of Chronic Heart Failure
NCT ID: NCT01939236
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2010-05-31
2012-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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 (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.
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.
Interventions
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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 (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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With a history of coronary heart disease, symptoms and signs; with difficult breathing, fatigue and fluid retention (edema); with left ventricular enlargement, end systolic volume of left ventricular increase and left ventricular ejection fraction (LVEF) ≤ 40; with New York Heart Association (NYHA) functional classificationⅡ or Ⅲ.
* Male or female subjects between 40 and 75 years old;
Exclusion Criteria
* Pulmonary artery hypertension caused by pulmonary heart disease, acute or chronic pulmonary embolism, or stroke within a half year.
* Serious hepatic insufficiency ( the index of liver function being 2 times of normal one), renal insufficiency (Ccr\>20%, Scr\>3mg/dl or 265 μmol/L), diseases of blood system, malignant tumor, diabetes mellitus with serious complications, hyperthyroid or hypothyroid.
* Infection: fever; the numeration of leukocyte being more than 10×109/L, the percentage of neutrophile granulocyte being more than 85%; patchy shadows in X ray of Chest, meeting one of the above three.
* Pregnancy or lactation; mental disease and infectious disease patients.
* Take part in other trials within two months.
45 Years
75 Years
ALL
No
Sponsors
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Wuhan Hospital of Traditional Chinese Medicine
OTHER
Zhengzhou Hospital of Traditional Chinese Medicine
OTHER
Changchun University of Chinese Medicine
OTHER
Hubei Hospital of Traditional Chinese Medicine
OTHER
Yichang Hospital of Traditional Chinese Medicine
OTHER
Dongzhimen Hospital, Beijing
OTHER
Guang'an Men Hospital Affiliated to China Academy of Chinese Medicine Sciences
UNKNOWN
Beijing University of Chinese Medicine
OTHER
Responsible Party
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Wei Wang
Vice-President
Principal Investigators
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Wei Wang, Doctor
Role: STUDY_CHAIR
Beijing University of Chinese Medicine
Peng Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Wuhan Hospital of Chinese Medicine
Huihui Zhao, Doctor
Role: STUDY_DIRECTOR
Beijing University of Chinese Medicine
Liangtao Luo, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing University of Chinese Medicine
Locations
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Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Countries
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References
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Gao K, Zhao H, Gao J, Wen B, Jia C, Wang Z, Zhang F, Wang J, Xie H, Wang J, Wang W, Chen J. Mechanism of Chinese Medicine Herbs Effects on Chronic Heart Failure Based on Metabolic Profiling. Front Pharmacol. 2017 Nov 22;8:864. doi: 10.3389/fphar.2017.00864. eCollection 2017.
Luo L, Chen J, Guo S, Wang J, Gao K, Zhang P, Chen C, Zhao H, Wang W. Chinese Herbal Medicine in the Treatment of Chronic Heart Failure: Three-Stage Study Protocol for a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:927160. doi: 10.1155/2015/927160. Epub 2015 May 18.
Other Identifiers
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BUCMlltllt1984
Identifier Type: -
Identifier Source: org_study_id