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Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis

NCT01420445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-09-26

No results posted yet for this study

Summary

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.

The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.

Conditions

  • Acute Bronchitis
  • Chronic Bronchitis

Interventions

DRUG

YHD001 dose level 1

three times daily / 7 days

DRUG

YHD001 dose level 2

three times daily / 7 days

DRUG

Pelargonium sidoides extract

6-9mL three times daily / 7 days

DRUG

placebo

three times daily / 7 days

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Young Kyoon Kim, M.D., Ph.D. · Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01420445 on ClinicalTrials.gov