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

Phase 3CompletedNCT01019889

Korea Health Industry Development Institute480 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

480

Conditions

Upper Respiratory Tract Infections

Interventions

SCRTDRUG

4 capsules,three times daily, for 7days or within symptom disappearance

YPSDRUG

4 capsules, three times daily, for 7days or within symptom disappearance

PlaceboDRUG

4 capsules, three times daily, for 7days or within symptom disappearance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes of score daily measured by WURSS-K before, during and after treatment

Time frame: daily (7 days)

Secondary Outcomes

Time of symptom disappearance

Time frame: daily

Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification

Time frame: daily (7days)

Data from ClinicalTrials.gov

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