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

The Dose-Effect Relationship Study of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome: an Open Label, Randomized, Dose-Response Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004598
Enrollment
Unknown
Registered
2021-01-01
Start date
2021-01-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Atrial Premature Beats

Interventions

Zero-dose Group:No-treatment
Low-dose Group:half-dose of Wenxin Granules (1/2 normal dose).
High-dose Group:double dose of Wenxin Granules (twice normal dose).
Medium-dose Group:medium-dose of Wenxin Granules (normal dose).

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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 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

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.

Design outcomes

Secondary

MeasureTime frame
Responder rate based on each symptom score;

Primary

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

Countries

China

Contacts

Public ContactHongli Wu

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

holiwu@yeah.net+86 10-64093248

Outcome results

None listed

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