Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Respiratory Infection

Treatments: Drug: DWKH-R; Drug: Placebo; Drug: DWKH

Study type: Interventional

Funder types: Industry

Identifiers

NCT05683951

DWKH-302

Details and patient eligibility

About

Randomized, Double-blind, Parellel, Multicenter, Active-controlled

Enrollment: 186 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female aged between 19 and 80.
• Patients whose BSS score is over 5.

Exclusion criteria

• Patients allergic to any ingredients of the study drugs.
• Moderate liver disease (ALT or AST > UNLx3).
• Moderate lung disease.
• Uncontrolled HTN.
• Uncontrolled DM.
• Uncontrolled thyroidism.
• Patients who is needed antibiotics during the study period.
• In the case of women, pregnant(Urine-HCG positive) or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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186 participants in 3 patient groups, including a placebo group

DWKH

Experimental group

Treatment:

Drug: DWKH

DWKH-R

Active Comparator group

Treatment:

Drug: DWKH-R

PLACEBO

Placebo Comparator group

Treatment:

Drug: Placebo