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
  Purpose

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.


Condition Intervention Phase
Upper Respiratory Tract Infections
Drug: SCRT
Drug: YPS
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection

Further study details as provided by Korea Health Industry Development Institute:

Primary Outcome Measures:
  • Changes of score daily measured by WURSS-K before, during and after treatment [ Time Frame: daily (7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 480
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Placebo (encapsulated starch + lactose)
Drug: Placebo
4 capsules, three times daily, for 7days or within symptom disappearance
Other Name: Placebo
Experimental: SCRT(Socheongryong-tang )
encapsulated Socheongryong-tang extract
Drug: SCRT
4 capsules,three times daily, for 7days or within symptom disappearance
Other Name: Xiao-qing-long-tang
Experimental: YPS (Yeongyopaedok-san)
Encapsulated Yeongyopaedok-san extract
Drug: YPS
4 capsules, three times daily, for 7days or within symptom disappearance
Other Name: Lian-qiao-bai-du-san

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019889

Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
Principal Investigator: YangChun Park, Ph. D. Daejeon University
  More Information

No publications provided

Responsible Party: Yang Chun Park, Professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01019889     History of Changes
Other Study ID Numbers: B070029
Study First Received: November 23, 2009
Last Updated: April 4, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Health Industry Development Institute:
upper respiratory tract infections
herbal medicine

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014