Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
Study NCT ID:
NCT04163835
Status:
UNKNOWN
Last Update Posted:
2022-11-18
First Post:
2019-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: