Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure
NCT ID: NCT01555320
Last Updated: 2013-03-20
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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UNKNOWN
NA
640 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Qishen Yiqi dripping pills dummy
Qishen Yiqi dripping pills dummy
One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
Qishen Yiqi Dripping Pills
Qishen Yiqi Dripping Pills
One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
Interventions
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Qishen Yiqi Dripping Pills
One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
Qishen Yiqi dripping pills dummy
One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
Eligibility Criteria
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Inclusion Criteria
* Patients with ischemic heart failure：
* LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
* History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG);
* Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure;
* With or without dyspnea, fatigue and fluid retention (edema) etc.
* History of heart failure or present with heart failure symptoms for at least 3 months;
* New York Heart Association (NYHA) Class II to IV;
* Submitted informed consent
Exclusion Criteria
* Those who have one of the following diseases:
* Acute coronary syndrome within 30 days
* Revascularization therapy within 6 months
* Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg
* Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia
* Dilated cardiomyopathy
* Hypertrophic obstructive cardiomyopathy
* Myocarditis
* Pulmonary artery embolism
* Severe valvular heart disease
* Pulmonary heart disease
* Stroke within 6 months
* Cardiac resynchronization therapy
* Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days
* Severe endocrine diseases such as hyperthyroidism, etc.
* History of malignant tumor
* Hemoglobin (HB )≤ 9g/dl
* Alanine aminotransferase (ALT) \> 2 times the upper limit of normal
* Serum creatinine \> 265 μmol/L
* Mental disorder
* Being pregnant, planning for pregnancy or breastfeeding
* Suspicious or definite allergy to intervention drugs
* Participated in other trials within 2 months
* Unable to walk autonomously due to physical disabilities
40 Years
79 Years
ALL
No
Sponsors
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State Administration of Traditional Chinese Medicine of the People's Republic of China
OTHER_GOV
Responsible Party
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Jingyuan Mao
Prof.
Principal Investigators
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Jingyuan Mao, Dr.
Role: PRINCIPAL_INVESTIGATOR
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Locations
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Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Guangdong Provincial Hospital of TCM
Guangdong, Guangdong, China
Second Affiliated Hospital of TCM College Guiyang
Guiyang, Guizhou, China
252 Hospital of Chinese People's Liberation Army
Baoding, Hebei, China
The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University
Heilongjiang, Heilongjiang, China
The First Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
The Affiliated Nanhua Hospital of Nanhua University
Hengyang, Hunan, China
Jiangsu Province Traditional Chinese Medicine Hospital
Nanjing, Jiangsu, China
Nanjing Hospital of T.C.M
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangxi University of TCM
Nanchang, Jiangxi, China
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Shandong Province Traditional Chinese Medicine University Affiliated Hospital
Shandong, Shandong, China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, China
Traditional Chinese Medicine Hospital of Shan Xi Province
Taiyuan, Shanxi, China
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Affiliated Hospital of Medical College of Chinese People's Armed Police Forces
Tianjin, Tianjin Municipality, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Second Affiliated Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
The 2nd Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tian Jin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affliated Hospital
Tianjin, Tianjin Municipality, China
Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Anhui University of TCM
Anhui, , China
Dong Fang Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Huan Liu, Dr.
Role: primary
References
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Hou YZ, Wang S, Zhao ZQ, Wang XL, Li B, Soh SB, Mao JY. Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF). Trials. 2013 May 14;14:138. doi: 10.1186/1745-6215-14-138.
Other Identifiers
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201007001-02
Identifier Type: -
Identifier Source: org_study_id
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