Clinical trial NCT04163835: The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
Official title: The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome : A Randomized, Double-blind, Placebo-controlled Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Premature Complexes
Keywords: Wenxin Granules
Dose-effect relationship
Deficiency of both Qi and Yin Syndrome
Heart Vessel Stasis and Obstruction Syndrome
Traditional Chinese Medicine
arrhythmia
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ratio of high, medium and low dose group and placebo groups are 1:1:1:1. A total of 60 cases are included in the first phase.The maximum sample size required is determined to be 150 cases.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Research purpose: 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.

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

Eligibility 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.

Primary outcomes:
measure: Responder rate based on 24-hour Holter monitoring.
timeFrame: Week 0 to Week 4
Secondary outcomes:
measure: Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.
timeFrame: Week 0 to Week 4
measure: Responder rate(%) based on each symptom score.
timeFrame: Week 0 to Week 4
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Week 0 to Week 4
measure: Impact of treatment on Liver Function
timeFrame: Week 0 to Week 4
measure: Impact of treatment on Renal Function
timeFrame: Week 0 to Week 4
measure: Impact of treatment on Hemoglobin Levels
timeFrame: Week 0 to Week 4
measure: Impact of treatment on White Blood Cells
timeFrame: Week 0 to Week 4
measure: Impact of treatment on Blood Platelet
timeFrame: Week 0 to Week 4
measure: Impact of treatment on Hematuria and Proteinuria
timeFrame: Week 0 to Week 4
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Hongli Wu
role: PRINCIPAL_INVESTIGATOR
References: