NCT02319603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.1 years

First QC Date

December 2, 2014

Last Update Submit

July 22, 2015

Conditions

Atrial Premature Beats

Outcome Measures

Primary Outcomes (1)

  • 24 h dynamic electrocardiogram (Holter)

    Baseline, up to 4 weeks, each record at a time.

    Baseline, up to 4 weeks, each record at a time.

Secondary Outcomes (1)

  • Symptom scores

    Baseline, up to 4 weeks, each record at a time.

Study Arms (2)

Low dose WenXin keli

ACTIVE COMPARATOR

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

High dose WenXin keli

EXPERIMENTAL

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

Interventions

Low dose WenXin keliDRUG

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

Also known as: the original quantity Wenxin keli
Low dose WenXin keli
High dose WenXin keliDRUG

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

Also known as: 2 times the amount of Wenxin keli
High dose WenXin keli

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Atrial Premature Complexes

Interventions

wenxin keli

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jihong Guo, doctor

    Director of department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihong Guo, doctor

CONTACT

13901148380

Jingbo Duan

CONTACT

18612189012duanjiangbo@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 18, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CN(1)