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

Phase 4

Recruiting

• Conditions: Atrial Premature Beats

• Registration Number: ITMCTR2100004598
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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 24h 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate based on 24-hour Holter monitoring;Change in Traditional Chinese Medicine Syndrome Score(TCMSS) From Baseline;

Secondary Outcome Measures

Name	Time	Method
Responder rate based on each symptom score;