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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019889
First Posted: November 25, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yang Chun Park, Korea Health Industry Development Institute
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection

Further study details as provided by Yang Chun Park, 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) ]

Secondary Outcome Measures:
  • Time of symptom disappearance [ Time Frame: daily ]
  • Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification [ Time Frame: daily (7days) ]

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019889


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

Responsible Party: Yang Chun Park, Professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01019889     History of Changes
Other Study ID Numbers: B070029
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: October 12, 2017
Last Verified: April 2012

Keywords provided by Yang Chun Park, Korea Health Industry Development Institute:
upper respiratory tract infections
herbal medicine

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