Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
NCT ID: NCT01612260
Last Updated: 2013-01-08
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
PHASE4
460 participants
INTERVENTIONAL
2012-09-30
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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Shensong Yangxin capsule
Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks
Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
placebo Capsule
placebo Capsule 4 granules t.i.d. po for 12weeks
placebo Capsule
4 granules t.i.d. po for 12 weeks
Interventions
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Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
placebo Capsule
4 granules t.i.d. po for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* To be treated by standard treatment of heart failure at least 3 months with a stable dosage already
* Ventricular premature beats: 720-10000 beats/24 hours
* Heart failure caused by ischemic heart disease, or dilated cardiomyopathy
Exclusion Criteria
* Subject suffered from acute coronary syndrome in last three months (Acute myocardial infarction of ST segment elevation and non ST segment elevation, unstable angina
* To be complicated with persistent atrial fibrillation, atrioventricular conduction block (II degree of Type II or III degree), or acute myocarditis
* To be complicated with ventricular fibrillation, torsion type ventricular heartbeat rate, sustained ventricular tachycardia, or non sustained ventricular tachycardia with rapid ventricular rate and hemodynamic disorders
* Sinus heart rate less than 45 beats/minutes and needs to receive the pacemaker or has received pacemaker, or with abnormal sinus node function
* The hypertension, diabetes difficult to be controlled
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Fudan University
OTHER
Shanghai Changzheng Hospital
OTHER
Nanjing Medical University
OTHER
Third Military Medical University
OTHER
Cong-xin Huang
OTHER
Responsible Party
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Cong-xin Huang
professor
Locations
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Beijing Anzhen Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, China
China-Japan Freindship Hospital
Beijing, Beijing Municipality, China
Chongqing Zhongshan Hospital
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Enshi Autonomous Region Central Hospital
Enshi, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
General Hospital of Dongfeng Motor Corporation
Shiyan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The First College of Clinical Medical Science, China Three Gorges University
Yichang, Hubei, China
First hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school
Nanjing, Jiangsu, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Traffic hospitals of Shandong Province
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Westchinahospital,Sichuanuniversity
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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changsheng Ma, PH D
Role: primary
yong Wang, PH D
Role: primary
xia Mei, PH D
Role: primary
yue Xia, PH D
Role: primary
chunguang Qiu, PH D
Role: primary
yuanhong Li, PH D
Role: primary
xin Li, PH D
Role: primary
handong Yang, PH D
Role: primary
yangyang Dai, PH D
Role: primary
wenwei Liu, PH D
Role: primary
jun Yang, PH D
Role: primary
tian Wang, PH D
Role: primary
yunzeng Zou, PH D
Role: primary
dejia Huang, PH D
Role: primary
References
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Wang X, Hu D, Dang S, Huang H, Huang CX, Yuan MJ, Tang YH, Zheng QS, Yin F, Zhang S, Zhang BL, Gao RL; Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive Heart Failure Study Group. Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial. Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.
Other Identifiers
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2012CB518600（2012CB518606）
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
yl-yxb06-lcsyfa-201201
Identifier Type: -
Identifier Source: org_study_id
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