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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

NCT03310385 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-03-05

No results posted yet for this study

Summary

This study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02, compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day), standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. Patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern Identification of Cough and Sputum, a diagnostic system that determines therapy in Traditional Korean Medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.

Conditions

  • Acute Bronchitis

Interventions

DRUG

GHX02

Herbal medicine originating from gualouhengryunhwan

DRUG

Placebo

Placebo tablets

Sponsors & Collaborators

  • Daejeon University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • South Korea

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 NCT03310385 on ClinicalTrials.gov