The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial, to evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses,to provide a scientific basis for rational clinical use of drug.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences

Criteria

Inclusion Criteria:

1. Accord with the diagnostic criteria of arrhythmia (atrial premature beats );

2. Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;

3. The number of premature beat of 24 h dynamic electrocardiogram >360 times/h or >8640 times/24h;

4. 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);

5. Ages 18 to 75 years old ,all genders;

6. Voluntary subjects and signed the informed consent form.

Exclusion Criteria:

1. Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;

2. Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;

3. Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);

4. Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;

5. Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;

6. Patients with severe hypotension;

7. Patients with serious cardiovascular diseases (such as congestive heart failure, cardiac shock, etc.), cerebrovascular disease, and serious primary 8.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);

8. Allergic constitution; the test drug allergy or its ingredients or elements allergy;

9. Pregnancy and lactation women ,recent preparation pregnancy;

10. Patients with chronic alcoholism , drug dependence, mental illness;

11. Participated in other clinical trials within 3 months.