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

NCT ID: NCT01420445

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.

Conditions

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Acute Bronchitis Chronic Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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YHD001 dose level 1

YHD001 dose level 1

Group Type EXPERIMENTAL

YHD001 dose level 1

Intervention Type DRUG

three times daily / 7 days

YHD001 dose level 2

YHD001 dose level 2

Group Type EXPERIMENTAL

YHD001 dose level 2

Intervention Type DRUG

three times daily / 7 days

Pelargonium sidoides extract

Pelargonium sidoides extract (Syrup)

Group Type ACTIVE_COMPARATOR

Pelargonium sidoides extract

Intervention Type DRUG

6-9mL three times daily / 7 days

Placebo

Placebo for YHD001 \& active comparator(syrup)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

three times daily / 7 days

Interventions

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YHD001 dose level 1

three times daily / 7 days

Intervention Type DRUG

YHD001 dose level 2

three times daily / 7 days

Intervention Type DRUG

Pelargonium sidoides extract

6-9mL three times daily / 7 days

Intervention Type DRUG

placebo

three times daily / 7 days

Intervention Type DRUG

Other Intervention Names

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Undecided Undecided UMCKAMIN Syrup

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged ≥18 year
* Provision of written informed consent
* Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points

Exclusion Criteria

* History of any clinically significant disease
* History of drug/chemical/alcohol abuse
* Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Kyoon Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea

Locations

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The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YHD001-202

Identifier Type: -

Identifier Source: org_study_id