Clincosm LogoSign in Get a demo

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

Sponsor
Korea Health Industry Development Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01019889
Collaborator
(none)
480
Enrollment
3
Arms
10
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
480 participants
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
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Lian-qiao-bai-du-san

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes of score daily measured by WURSS-K before, during and after treatment [daily (7 days)]

    Secondary Outcome Measures

    1. Time of symptom disappearance [daily]

    2. Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification [daily (7days)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Korea Health Industry Development Institute

    Investigators

    • Principal Investigator: YangChun Park, Ph. D., Daejeon University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yang Chun Park, Professor, Korea Health Industry Development Institute
    ClinicalTrials.gov Identifier:
    NCT01019889
    Other Study ID Numbers:
    • B070029
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Apr 6, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Yang Chun Park, Professor, Korea Health Industry Development Institute
    upper respiratory tract infections
    herbal medicine
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Apr 6, 2012