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

Official Title: “Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Placebo
  • Placebo (encapsulated starch + lactose)
• Experimental: SCRT(Socheongryong-tang )
  • encapsulated Socheongryong-tang extract
• Experimental: YPS (Yeongyopaedok-san)
  • Encapsulated Yeongyopaedok-san extract

Primary Measures

• Changes of score daily measured by WURSS-K before, during and after treatment
  • Time Frame: daily (7 days)
    Safety Issue?: No

Secondary Measures

• Time of symptom disappearance
  • Time Frame: daily
    Safety Issue?: No
• Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification
  • Time Frame: daily (7days)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Korea Health Industry Development Institute Other

Overall Clinical Trial Officials and Contacts

YangChun Park, Ph. D. Principal Investigator Daejeon University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019889

Study ID Number: B070029

ClinicalTrials.gov Identifier: NCT01019889

Health Authority: Korea: Food and Drug Administration