Clinical Trials to Assess the Efficacy and Safety of HLIM

SamA Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Acute Bronchitis; Acute Upper Respiratory Tract Infection

Treatments: Drug: Test; Drug: Active Comparator Control 2; Drug: Active Comparator Control 1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03827590

HLIM(SA16002)

Details and patient eligibility

About

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

Full description

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

Enrollment: 487 estimated patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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487 participants in 4 patient groups, including a placebo group

HLIM

Experimental group

Description:

HLIM+SA160021 Placebo+SA160022 Placebo

Treatment:

Drug: Test

SA160021

Active Comparator group

Description:

HLIM Placebo+SA160021+SA160022 Placebo

Treatment:

Drug: Active Comparator Control 1

SA160022

Active Comparator group

Description:

HLIM Placebo+SA160021 Placebo+SA160022

Treatment:

Drug: Active Comparator Control 2

Placebo

Placebo Comparator group

Description:

HLIM Placebo+SA160021 Placebo+SA160022 Placebo

Treatment:

Drug: Placebo