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To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319603
Recruitment Status : Unknown
Verified July 2015 by Beijing Bozhiyin T&S Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 18, 2014
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Beijing Bozhiyin T&S Co., Ltd.

Study Description
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Brief Summary:
A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.

Condition or disease Intervention/treatment Phase
Atrial Premature Beats Drug: Low dose WenXin keli Drug: High dose WenXin keli Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats.
Study Start Date : January 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low dose WenXin keli

Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.

Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.

 Drug: Low dose WenXin keli
Low dose WenXin keli (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
Other Name: the original quantity Wenxin keli
Experimental: High dose WenXin keli

High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.

Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment.

 Drug: High dose WenXin keli
High dose WenXin keli(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Other Name: 2 times the amount of Wenxin keli


Outcome Measures
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Primary Outcome Measures :
  1. 24 h dynamic electrocardiogram (Holter) [ Time Frame: Baseline, up to 4 weeks, each record at a time. ]
    Baseline, up to 4 weeks, each record at a time.


Secondary Outcome Measures :
  1. Symptom scores [ Time Frame: Baseline, up to 4 weeks, each record at a time. ]
    Baseline, up to 4 weeks, each record at a time.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accord with the diagnostic criteria of arrhythmia (atrial premature beats )
  • The average number of premature beat of 24 h dynamic electrocardiogram >360 times/h (effective record at least 22 h)
  • Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina)
  • Ages 18 to 75 years old ,all genders
  • Voluntary subjects and signed the informed consent form

Exclusion Criteria:

  • Need to merge other anti-arrhythmic drugs(Ⅰ,Ⅱ,Ⅲ,Ⅳ) for serious condition
  • Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders
  • Merge tardy arrhythmia (including sick sinus syndrome and Ⅱdegree atrioventricular block)
  • Patients have had heart percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery
  • Patients with severe hypotension
  • With serious cardiovascular diseases (severe coronary heart disease, congenital heart disease, cardiomyopathy, myocardial infarction, congestive heart failure, cardiac shock, etc.), cerebrovascular disease, severe respiratory diseases (chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, etc.),serious primary diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal)
  • Allergic constitution; the test drug allergy or its ingredients or elements allergy
  • Pregnancy and lactation women ,recent preparation pregnancy
  • With chronic alcoholism , drug dependence, mental illness
  • Participated in other clinical trials within 3 months
  • Patients thought by the investigators not suitable to participate in clinical trials
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02319603


Contacts
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Contact: Jihong Guo, doctor 13901148380
Contact: Jingbo Duan 18612189012 duanjiangbo@gmail.com

Locations
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China, Beijing
Peking University people's hospital Recruiting
Beijing, Beijing, China, 100044
Contact: duan jingbo, visiting staff    18612189012    duanjiangbopku@126.com   
Sponsors and Collaborators
Beijing Bozhiyin T&S Co., Ltd.
Investigators
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Principal Investigator: Jihong Guo, doctor Director of department
More Information
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Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier: NCT02319603    
Other Study ID Numbers: WX-20141022
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Premature Birth
Cardiac Complexes, Premature
Atrial Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes