NCT03827590

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
487

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

January 10, 2019

Last Update Submit

February 7, 2019

Conditions

Acute Upper Respiratory Tract InfectionAcute Bronchitis

Outcome Measures

Primary Outcomes (2)

  • Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo

    0(absent) \~ 4(very severe), Total Score: 0\~20

    5 days

  • Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group

    0(absent) \~ 4(very severe), Total Score: 0\~20

    5 days

Study Arms (4)

HLIM

EXPERIMENTAL

HLIM+SA160021 Placebo+SA160022 Placebo

Drug: Test

SA160021

ACTIVE COMPARATOR

HLIM Placebo+SA160021+SA160022 Placebo

Drug: Active Comparator Control 1

SA160022

ACTIVE COMPARATOR

HLIM Placebo+SA160021 Placebo+SA160022

Drug: Active Comparator Control 2

Placebo

PLACEBO COMPARATOR

HLIM Placebo+SA160021 Placebo+SA160022 Placebo

Drug: Placebo

Interventions

TestDRUG

three times a day for five days

Also known as: HLIM+SA160021 Placebo+SA160022 Placebo
HLIM
Active Comparator Control 1DRUG

three times a day for five days

Also known as: HLIM Placebo+SA160021+SA160022 Placebo
SA160021
Active Comparator Control 2DRUG

three times a day for five days

Also known as: HLIM Placebo+SA160021 Placebo+SA160022
SA160022
PlaceboDRUG

three times a day for five days

Also known as: HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Placebo

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Has a history of hypersensitivity to IP ingredients
  • Hypertension or Diabetes
  • Smoking more than 20 pack-years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

February 1, 2019

Study Start

November 29, 2018

Primary Completion

May 30, 2019

Study Completion

October 31, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

KR(1)