Back to resultsTraditional Chinese Medicine for Treatment of Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
traditional Chinese medicine
Placebo (gummeline)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, traditional Chinese medicine, syndrome differentiation
Eligibility Criteria
Inclusion Criteria:
- The basic primary heart disease is coronary heart disease ( with diagnosis for coronary heart disease : confirmed by coronary angiography; confirmed by coronary CT; history of acute myocardial infarction; limb-salvage Q wave for ECG; ecg ECG test and radionuclide examination support, etc.); no history of hypertension or taking antihypertensive drugs, with blood pressure under 160/100 mmHg.
- 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:
- Serious valvular heart disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction ( within 4 weeks), cardiac shock, acute myocarditis or serious arrhythmia with the variation of hemodynamics.
- 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.
Sites / Locations
- Beijing University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
traditional Chinese medicine
placebo (gummeline)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
The level of left ventricular ejection fraction was detected with the modified Simpson's rule at baseline and 28 days.
Secondary Outcome Measures
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.
New York Heart Association (NYHA) functional classification
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.
Full Information
NCT ID
NCT01939236
First Posted
August 13, 2013
Last Updated
October 8, 2013
Sponsor
Beijing University of Chinese Medicine
Collaborators
Wuhan Hospital of Traditional Chinese Medicine, Zhengzhou Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Yichang Hospital of Traditional Chinese Medicine, Dongzhimen Hospital, Beijing, Guang'an Men Hospital Affiliated to China Academy of Chinese Medicine Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01939236
Brief Title
Traditional Chinese Medicine for Treatment of Chronic Heart Failure
Official Title
Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
Collaborators
Wuhan Hospital of Traditional Chinese Medicine, Zhengzhou Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Yichang Hospital of Traditional Chinese Medicine, Dongzhimen Hospital, Beijing, Guang'an Men Hospital Affiliated to China Academy of Chinese Medicine Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, traditional Chinese medicine, syndrome differentiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional Chinese medicine
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo (gummeline)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
traditional Chinese medicine
Other Intervention Name(s)
Qi deficiency：huangqi, dangshen, Blood stasis: danshen, chishao,taoren, honghua, Water retention: zexie, zhuling, cheqianzi, tinglizi, Yang deficiency: rougui, zhifuzi
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (gummeline)
Other Intervention Name(s)
Qi deficiency： gummeline, Blood stasis: gummeline, Water retention: gummeline, Yang deficiency: gummeline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
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
Secondary Outcome Measure Information:
Title
Traditional Chinese medicine syndrome scores (TCM-SS)
Description
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
Title
New York Heart Association (NYHA) functional classification
Time Frame
14 days, 28 days
Title
6-minute walk test (6MWT)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The basic primary heart disease is coronary heart disease ( with diagnosis for coronary heart disease : confirmed by coronary angiography; confirmed by coronary CT; history of acute myocardial infarction; limb-salvage Q wave for ECG; ecg ECG test and radionuclide examination support, etc.); no history of hypertension or taking antihypertensive drugs, with blood pressure under 160/100 mmHg.
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:
Serious valvular heart disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction ( within 4 weeks), cardiac shock, acute myocarditis or serious arrhythmia with the variation of hemodynamics.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Wang, Doctor
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peng Zhang, Doctor
Organizational Affiliation
Wuhan Hospital of Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huihui Zhao, Doctor
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liangtao Luo, Master
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29213243
Citation
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.
Results Reference
derived
PubMed Identifier
26089951
Citation
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.
Results Reference
derived
Learn more about this trial
Traditional Chinese Medicine for Treatment of Chronic Heart Failure
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