The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats (NCT04163835) | Clinical Trial Compass
UnknownPhase 4
The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
China150 participantsStarted 2015-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Accord with the diagnostic criteria of arrhythmia (atrial premature beats );
. Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
. The number of premature beat of 24 h dynamic electrocardiogram \>360 times/h or \>8640 times/24h;
. 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);
. Ages 18 to 75 years old ,all genders;
. Voluntary subjects and signed the informed consent form.
Exclusion criteria
. Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
. Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
. Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
. Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Responder rate based on 24-hour Holter monitoring.
. Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;
. Patients with severe hypotension;
. 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);
. Allergic constitution; the test drug allergy or its ingredients or elements allergy;