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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yang Chun Park, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT01019889
First received: November 23, 2009
Last updated: April 4, 2012
Last verified: April 2012

November 23, 2009
April 4, 2012
September 2008
June 2009   (final data collection date for primary outcome measure)
Changes of score daily measured by WURSS-K before, during and after treatment [ Time Frame: daily (7 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019889 on ClinicalTrials.gov Archive Site
  • Time of symptom disappearance [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification [ Time Frame: daily (7days) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Upper Respiratory Tract Infections
  • Drug: SCRT
    4 capsules,three times daily, for 7days or within symptom disappearance
    Other Name: Xiao-qing-long-tang
  • Drug: YPS
    4 capsules, three times daily, for 7days or within symptom disappearance
    Other Name: Lian-qiao-bai-du-san
  • Drug: Placebo
    4 capsules, three times daily, for 7days or within symptom disappearance
    Other Name: Placebo
  • Experimental: Placebo
    Placebo (encapsulated starch + lactose)
    Intervention: Drug: Placebo
  • Experimental: SCRT(Socheongryong-tang )
    encapsulated Socheongryong-tang extract
    Intervention: Drug: SCRT
  • Experimental: YPS (Yeongyopaedok-san)
    Encapsulated Yeongyopaedok-san extract
    Intervention: Drug: YPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
July 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01019889
B070029
No
Yang Chun Park, Korea Health Industry Development Institute
Korea Health Industry Development Institute
Not Provided
Principal Investigator: YangChun Park, Ph. D. Daejeon University
Korea Health Industry Development Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP