The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
NCT ID: NCT04163835
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2015-09-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
NCT04661709
Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
NCT01612260
Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
NCT04695990
Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure
NCT03027375
Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions
NCT01750775
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research design: A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial.
Sample size:
The ratio of high, medium and low dose groups and placebo group were 1:1:1:1. A total of 60 cases were included in the first phase.The maximum sample size required was determined to be 150 cases.
Therapeutic schedule:
1. Low-dose Group(1/2 Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
2. Medium-dose Group(Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
3. High-dose Group(Twice Normal-dose Wenxin Granules):Wenxin Granules (no sucrose) 10g.
4. Placebo Group(Placebo):Wenxin Granules placebo 10g.
Usage and Dosage:The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Drug combination:
During the test should not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.
Primary Outcome Measures
1\. Responder rate based on 24-hour Holter monitoring, defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.
Time Frame: Week 0 to Week 4
Secondary Outcome Measures
1. Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale (TCMSSS).
Time Frame: Week 0 to Week 4
2. Responder rate based on each symptom score, defined as the proportion (%) of subjects with a ≥ 1 score reduction in each symptom score from baseline.
Time Frame: Week 0 to Week 4
Other Outcome Measures
1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time Frame: Week 0 to Week 4
2. Impact of treatment on Liver Function Time Frame: Week 0 to Week 4
3. Impact of treatment on Renal Function Time Frame: Week 0 to Week 4
4. Impact of treatment on Hemoglobin Levels Time Frame: Week 0 to Week 4
5. Impact of treatment on White Blood Cells Time Frame: Week 0 to Week 4
6. Impact of treatment on Blood Platelet Time Frame: Week 0 to Week 4
7. Impact of treatment on Hematuria and Proteinuria Time Frame: Week 0 to Week 4
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Unblinding should be done by the statisticians when the data collection process was completed or the treating physicians when serious adverse events occurred.
The maximum sample size required is determined to be 150 cases.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-dose Group
The intervention is half-dose of Wenxin Granules (1/2 normal dose).
1/2 Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Medium-dose Group
The intervention is medium-dose of Wenxin Granules (normal dose).
Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
High-dose Group
The intervention is twice-dose of Wenxin Granules (twice normal dose).
Twice Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 10g.
Placebo Group
The intervention is a placebo.
Placebo
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules placebo 10g.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
1/2 Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Twice Normal-dose Wenxin Granules
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 10g.
Placebo
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules placebo 10g.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhong Wang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongli Wu
Role: PRINCIPAL_INVESTIGATOR
China Academy of Chinese Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WX20150820
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.