Clinical Trials to Assess the Efficacy and Safety of HLIM

Phase 3

• Conditions: Acute Upper Respiratory Tract Infection; Acute Bronchitis
• Interventions: Drug: Active Comparator Control 2; Drug: Active Comparator Control 1; Drug: Placebo; Drug: Test

• Registration Number: NCT03827590
• Lead Sponsor: SamA Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-11-29
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-31
• Status Verified: 2019-02
• Study First Posted: 2019-02-01
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08
• Primary Completion: 2019-05-30
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 487

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SA160022	Active Comparator Control 2	HLIM Placebo+SA160021 Placebo+SA160022
SA160021	Active Comparator Control 1	HLIM Placebo+SA160021+SA160022 Placebo
Placebo	Placebo	HLIM Placebo+SA160021 Placebo+SA160022 Placebo
HLIM	Test	HLIM+SA160021 Placebo+SA160022 Placebo

Primary Outcome Measures

Name	Time	Method
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo	5 days	0(absent) \~ 4(very severe), Total Score: 0\~20
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group	5 days	0(absent) \~ 4(very severe), Total Score: 0\~20

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of