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

No results posted yet for this study

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

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.

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163835 on ClinicalTrials.gov