Clinical Trials to Assess the Efficacy and Safety of HLIM

NCT ID: NCT03827590

Last Updated: 2019-02-08

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

487 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-10-31

Brief Summary

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The purpose of this study is to assess the efficacy and safety of HLIM

Detailed Description

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A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Conditions

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Acute Upper Respiratory Tract Infection Acute 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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HLIM

HLIM+SA160021 Placebo+SA160022 Placebo

Group Type EXPERIMENTAL

Test

Intervention Type DRUG

three times a day for five days

SA160021

HLIM Placebo+SA160021+SA160022 Placebo

Group Type ACTIVE_COMPARATOR

Active Comparator Control 1

Intervention Type DRUG

three times a day for five days

SA160022

HLIM Placebo+SA160021 Placebo+SA160022

Group Type ACTIVE_COMPARATOR

Active Comparator Control 2

Intervention Type DRUG

three times a day for five days

Placebo

HLIM Placebo+SA160021 Placebo+SA160022 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

three times a day for five days

Interventions

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Test

three times a day for five days

Intervention Type DRUG

Active Comparator Control 1

three times a day for five days

Intervention Type DRUG

Active Comparator Control 2

three times a day for five days

Intervention Type DRUG

Placebo

three times a day for five days

Intervention Type DRUG

Other Intervention Names

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HLIM+SA160021 Placebo+SA160022 Placebo HLIM Placebo+SA160021+SA160022 Placebo HLIM Placebo+SA160021 Placebo+SA160022 HLIM Placebo+SA160021 Placebo+SA160022 Placebo

Eligibility Criteria

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Inclusion Criteria

* Age between 2 and 75
* Weight more than 11.5 kg

Exclusion Criteria

* Has a history of hypersensitivity to IP ingredients
* Hypertension or Diabetes
* Smoking more than 20 pack-years
Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SamA Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jaejung Shim, M.D., Ph.D

Role: primary

+82-2-2626-1114

Other Identifiers

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HLIM(SA16002)

Identifier Type: -

Identifier Source: org_study_id

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