Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection (ESYUI)

Korea Health Industry Development Institute

Status and phase: Completed; Phase 3

Conditions: Upper Respiratory Tract Infections

Treatments: Drug: SCRT; Drug: YPS; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01019889

B070029

Details and patient eligibility

About

The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.

Full description

Upper respiratory tract infections (URTIs) are the most prevalent disease of human beings, it incur a significant health burden on populations in terms of human suffering and economic losses. Usually, antibiotic therapy is not helpful since most infections are virally induced. Over 200 serologically different viral types are responsible for human URTIs, so that preventions of URTIs including vaccination are impassable. SCRT and YPS are widely used to treat the respiratory disease. The objective of this study is to determine the efficacy of SCRT and YPS in symptomatic relief of patients with URTIs.

Enrollment: 480 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18~60 years old
• Clinical diagnosis of common cold
• Occurring no longer than 48 hours before enrollment
• Presented with runny nose, sore throat, plugged nose, scratchy throat, cough, hoarseness, headache, muscle ache (runny nose, sore throat and at least 1 of others or 1 of runny nose, sore throat and at least 3 of others)

Exclusion criteria

• Allergic rhinitis, asthma, COPD, sinusitis (2 and more recurrence per year), septal deviation, anatomical otitis media, exudative pharyngitis
• Received antihistamines, NSAIDs, corticosteroids, antibiotics, decongestants
• Hepatic cancer, liver cirrhosis, renal failure, congestive heart failure
• Pregnant or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 3 patient groups

Placebo

Experimental group

Description:

Placebo (encapsulated starch + lactose)

Treatment:

Drug: Placebo

SCRT(Socheongryong-tang )

Experimental group

Description:

encapsulated Socheongryong-tang extract

Treatment:

Drug: SCRT

YPS (Yeongyopaedok-san)

Experimental group

Description:

Encapsulated Yeongyopaedok-san extract

Treatment:

Drug: YPS