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NCT01019889 Clinical Trial

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

Upper Respiratory Tract Infections Clinical Trial

— ESYUI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01019889
Other study ID # B070029
Secondary ID
Status Completed
Phase Phase 3
First received November 23, 2009
Last updated April 4, 2012
Start date September 2008
Est. completion date July 2009

Study information
Verified date April 2012
Source Korea Health Industry Development Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 480
Est. completion date July 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SCRT
4 capsules,three times daily, for 7days or within symptom disappearance
• YPS
4 capsules, three times daily, for 7days or within symptom disappearance
• Placebo
4 capsules, three times daily, for 7days or within symptom disappearance

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Korea Health Industry Development Institute

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of score daily measured by WURSS-K before, during and after treatment daily (7 days)
Secondary Time of symptom disappearance daily
Secondary Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification daily (7days)
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