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

Primary Purpose

Upper Respiratory Tract Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SCRT
YPS
Placebo
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infections focused on measuring upper respiratory tract infections, herbal medicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    SCRT(Socheongryong-tang )

    YPS (Yeongyopaedok-san)

    Arm Description

    Placebo (encapsulated starch + lactose)

    encapsulated Socheongryong-tang extract

    Encapsulated Yeongyopaedok-san extract

    Outcomes

    Primary Outcome Measures

    Changes of score daily measured by WURSS-K before, during and after treatment

    Secondary Outcome Measures

    Time of symptom disappearance
    Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification

    Full Information

    First Posted
    November 23, 2009
    Last Updated
    April 4, 2012
    Sponsor
    Korea Health Industry Development Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01019889
    Brief Title
    Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
    Acronym
    ESYUI
    Official Title
    Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea Health Industry Development Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Respiratory Tract Infections
    Keywords
    upper respiratory tract infections, herbal medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    Placebo (encapsulated starch + lactose)
    Arm Title
    SCRT(Socheongryong-tang )
    Arm Type
    Experimental
    Arm Description
    encapsulated Socheongryong-tang extract
    Arm Title
    YPS (Yeongyopaedok-san)
    Arm Type
    Experimental
    Arm Description
    Encapsulated Yeongyopaedok-san extract
    Intervention Type
    Drug
    Intervention Name(s)
    SCRT
    Other Intervention Name(s)
    Xiao-qing-long-tang
    Intervention Description
    4 capsules,three times daily, for 7days or within symptom disappearance
    Intervention Type
    Drug
    Intervention Name(s)
    YPS
    Other Intervention Name(s)
    Lian-qiao-bai-du-san
    Intervention Description
    4 capsules, three times daily, for 7days or within symptom disappearance
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    4 capsules, three times daily, for 7days or within symptom disappearance
    Primary Outcome Measure Information:
    Title
    Changes of score daily measured by WURSS-K before, during and after treatment
    Time Frame
    daily (7 days)
    Secondary Outcome Measure Information:
    Title
    Time of symptom disappearance
    Time Frame
    daily
    Title
    Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification
    Time Frame
    daily (7days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    YangChun Park, Ph. D.
    Organizational Affiliation
    Daejeon University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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