NCT04163835

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Premature Complexes

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2019-11-15
• Last updated: 2022-11-18

Locations

1 site across 1 country: China