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

Phase 3

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Drug: Placebo; Drug: SCRT; Drug: YPS

• Registration Number: NCT01019889
• Lead Sponsor: Korea Health Industry Development Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (encapsulated starch + lactose)
SCRT(Socheongryong-tang )	SCRT	encapsulated Socheongryong-tang extract
YPS (Yeongyopaedok-san)	YPS	Encapsulated Yeongyopaedok-san extract

Primary Outcome Measures

Name	Time	Method
Changes of score daily measured by WURSS-K before, during and after treatment	daily (7 days)

Secondary Outcome Measures

Name	Time	Method
Time of symptom disappearance	daily
Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification	daily (7days)