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Wenxinkeli arrhythmia randomized double-blind, parallel placebo-controlled, multi-center clinical trial evidence

Wenxinkeli ? stage clinical trials

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002159
Enrollment
Unknown
Registered
2012-01-04
Start date
2010-03-08
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia(atrial premature beats, ventricular premature beats)

Interventions

first:placebo
second:wenxin keli

Sponsors

Fuwai Cardiovascular Institute & Heart Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. diagnostic criteria in line with arrhythmias (atrial premature beats, ventricular premature beats); 2. Premature beats> 360 beats / hour or> 8640/24 hours; 3. Are taking anti-arrhythmic drugs are disabled for more than a half-life of 5; 4. Aged 18 to 75-year-old, male or female; 5. Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious condition be combined with other drug treatment; 2. Arrhythmia caused by drugs, electrolyte or acid-base balance disorders and other factors; 3. The slow arrhythmia(Including sick sinus syndrome and II degree atrioventricular block); 4. Removal of incentives (such as fatigue, nervousness, mood swings, alcoholism, etc.) after premature to reduce symptoms remission; 5. Have a pacemaker or heart PCI surgery; 6. Patients with severe hypotension; 7. Patients with severe heart (congestive heart failure, cardiogenic shock), cerebrovascular diseases, liver, kidney and hematopoietic system such as severe primary disease (ALT and AST, BUN, higher than 2 times the upper limit of normal, or Cr and highthe upper limit of normal); 8. The known composition of the test drug allergy and allergic; 9. Pregnancy and lactating women, recently prepared, pregnancy; 10. Long-term alcoholism, drug dependence, mental illness; 11. Participated in other clinical trials in the three months.

Design outcomes

Primary

MeasureTime frame
Holter;12 - lead EC;

Secondary

MeasureTime frame
Liver and kidney function, Lipids, Blood sugar;

Countries

China

Contacts

Public ContactHua Wei
drhua@vip.sina.com+86 13801134270

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026