Clinical Trials to Assess the Efficacy and Safety of HLIM

Phase 3UnknownNCT03827590

SamA Pharmaceutical Co., Ltd487 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

487

Conditions

Acute Upper Respiratory Tract Infection Acute Bronchitis

Interventions

TestDRUG

three times a day for five days

Active Comparator Control 1DRUG

three times a day for five days

Active Comparator Control 2DRUG

three times a day for five days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 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

Time frame: 5 days

Data from ClinicalTrials.gov

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