AzTrials
AzTrials

Premature Ventricular ContractionPhase 4SS-SBVPTNCT01750775

Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions

A Phase 4 study testing Shensong Yangxin capsule in people with Premature Ventricular Contraction, run by kejiang Cao at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Premature Ventricular Contraction
What is being tested?
Shensong Yangxin capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
1 siteChina
Study dates
Aug 2012to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Nanjing Medical Universtiy

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study

The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats.

Read the detailed description

Premature ventricular contractions is one of the most common symptomatic arrhythmia. Antiarrhythmia drugs for premature ventricular contractions, such as beta-blockers and sodium channel blockers, can cause bradycardia. For sinus bradycardia patients complicated with premature ventricular contractions, it's hard for doctors to make decision. The purpose of the study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions and average hear rate in 24-hour ambulatory electrocardiogram (ECG) after 8 weeks treatment as the primary endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Sinus bradycardia patients(average heart rate 45-59 beat per minute) associated with premature ventricular contractions (PVC number >10000 / 24h), are involved in the study. Patients are randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 8 weeks. 24-hour ambulatory ECG, are observed at baseline,4 weeks and 8 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions and average heat rate in 24-hour ambulatory ECG, and the secondary outcomes is Minnesota living with heart failure questionnaire (MLHFQ).

Being tested
Shensong Yangxin capsule, placebo Capsule
Keywords
sinus bradycardia, ventricular premature contraction
Medical subject headings
Ventricular Premature Complexes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shensong Yangxin capsuleDrug

    ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks

  • placebo CapsuleDrug

    placebo Capsule 4 granules t.i.d. by mouth for 8 weeks

Study groups in NCT01750775
Study groupRoleWhat they receive
Shensong Yangxin capsuleExperimentalShensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks
Receives: Drug: Shensong Yangxin capsule
placebo CapsulePlacebo comparatorplacebo Capsule 4 granules t.i.d. by mouth for 8 weeks
Receives: Drug: placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG

    Measured: 8 weeks

  2. average heart rate detected by 24-hour ambulatory ECG

    Measured: 8 weeks

Secondary outcomes (2)

  1. numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG

    Measured: 4 weeks

  2. average heart rate detected by 24-hour ambulatory ECG

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionSep 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750775
Sponsor's protocol ID
yl-yxb07-lcsyfa-201202
Other IDs
ChiCTR-TRC-12002504
Acronym
SS-SBVPT
Status last verified
Dec 2012
First submitted
6 Dec 2012
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhang F, Zou J, Yu H, Li X, Kojodjojo P, Cai X, Zhang S, Huang C, Hong K, Yu B, Li G, Luo S, Zhou S, Zheng Y, Fan J, Cao X, Tao G, Sheng G, Bai Z, Jiang S, Liu X, Gu W, Chen F, Cao K. Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial. Evid Based Complement Alternat Med. 2019 Mar 4;2019:3917282. doi: 10.1155/2019/3917282. eCollection 2019.

    PubMed 30949218

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shensong Yangxin capsule in people with Premature Ventricular Contraction, run by kejiang Cao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01750775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in