ventricular premature beat
Conditions
Interventions
Test drug group:XSN Capsule: oral, 4 capsules each time, three times a day
Mexiletine hydrochloride simulation agent: oral, 2 tablets (50 mg/tablet) each time, 3 times a day
Active medicine control:mexiletine hydrochloride: oral, 2 tablets (50 mg/tablet) each time, 3 times a day
XSN Capsule simulation agent: oral, 4 tablets each time, 3 times a day
Placebo group:XSN Capsule simulation agent: oral, 4 tablets each time, 3 times a day
Mexiletine hydrochloride simulation agent, oral, 2 tablets (50 mg/tablet), 3 times a day
Sponsors
BeijingChao-YangHospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the western medicine diagnosis criteria of ventricular premature beat; (2) Belonging to functional or normally cardiac functional type organic VPB; (3) VPB > 7200 times /24 hours and< 12960 times / 24 hours; (4) Aged 18 to 75 years; (5) More than 2 weeks after stopping a use of Chinese medicines relating to the treatment of cardiovascular diseases, and 5 half-lives or above after stopping a use of western medicines; (6) Signing the informed consent.
Exclusion criteria
Exclusion criteria: (1) Those with severe conditions needing the use of other anti-arrhythmic drug therapy; (2) Those with VPB caused by acute myocardial infarction, acute heart failure and other system diseases (e.g. anemia, hyperthyroidism, and so forth), digitalis poisoning and electrolyte disorders, or left ventricular ejection fraction 1.5 times normal upper limit, and blood Cr > upper limit; (6) Those undergoing heart PCI or bypass surgery during recent 3 months; (7) Those with high blood pressure level 3 or above (a high risk level) and their blood pressure under instable control; (8) Those allergic to test drug ingredients or with allergic constitution; (9) Those participating in other clinical tests within recent three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic effect in 24-hour dynamic ECG (holter) of VPB; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of main symptoms (heart palpitations and chest tightness);Therapeutic effect in 24-hour dynamic ECG (holter) of APB; | — |
Countries
China
Contacts
Public ContactPeng Mao
Shanxi Momentum Pharmaceutcal Company
Outcome results
None listed