Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions (SS-SBVPT)
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ClinicalTrials.gov Identifier: NCT01750775 |
Recruitment Status : Unknown
Verified December 2012 by kejiang Cao, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Enrolling by invitation
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Premature Ventricular Contraction | Drug: Shensong Yangxin capsule Drug: placebo Capsule | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | September 2013 |
Estimated Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Shensong Yangxin capsule
Shensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks
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Drug: Shensong Yangxin capsule
ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks |
Placebo Comparator: placebo Capsule
placebo Capsule 4 granules t.i.d. by mouth for 8 weeks
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Drug: placebo Capsule
placebo Capsule 4 granules t.i.d. by mouth for 8 weeks |
- numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG [ Time Frame: 8 weeks ]
- average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 8 weeks ]
- numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]
- average heart rate detected by 24-hour ambulatory ECG [ Time Frame: 4 weeks ]
- Minnesota living with heart failure questionnaire (MLHFQ) [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 Years to 70 Years old
- Documented sinus bradycardia with average heart rate at 45-59 by 24hours ambulatory EKG
- Ventricular premature beats: >1000 beats/24 hours
Exclusion Criteria:
- Younger than 18 years or older than 75 years
- Symptomatic sinus arrest >3 seconds or high degree atrioventricular block indicated for pacemaker
- 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, or paroxysmal atrial fibrillation >5% during 24hrs ambulatory EKG 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 ICD,CRTP/D

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): NCT01750775
China, Jiangsu | |
the First Affiliated Hospital of Nanjing Medical Universtiy | |
Nanjing, Jiangsu, China |
Principal Investigator: | Kejiang Cao, M.D | The First Affiliated Hospital with Nanjing Medical University |
Additional Information:
Responsible Party: | kejiang Cao, director of cardiology cepartment, The First Affiliated Hospital with Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT01750775 History of Changes |
Other Study ID Numbers: |
yl-yxb07-lcsyfa-201202 ChiCTR-TRC-12002504 ( Other Identifier: ChiCTR ) |
First Posted: | December 17, 2012 Key Record Dates |
Last Update Posted: | December 17, 2012 |
Last Verified: | December 2012 |
Keywords provided by kejiang Cao, The First Affiliated Hospital with Nanjing Medical University:
sinus bradycardia ventricular premature contraction |
Additional relevant MeSH terms:
Premature Birth Bradycardia Ventricular Premature Complexes Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cardiac Complexes, Premature |