The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
NCT04163835 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2022-11-18
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.
Conditions
- Atrial Premature Complexes
Interventions
- 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
-
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules placebo 10g.
Sponsors & Collaborators
-
China Academy of Chinese Medical Sciences
lead OTHER
Principal Investigators
-
Hongli Wu · China Academy of Chinese Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- China
Study Locations
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