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

April 4, 2012 updated by: Yang Chun Park, Korea Health Industry Development Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of score daily measured by WURSS-K before, during and after treatment
Time Frame: daily (7 days)
daily (7 days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Health Industry Development Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B070029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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