NCT01019889

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

November 23, 2009

Last Update Submit

April 4, 2012

Conditions

Upper Respiratory Tract Infections

Keywords

upper respiratory tract infectionsherbal medicine

Outcome Measures

Primary Outcomes (1)

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

    daily (7 days)

Secondary Outcomes (2)

  • Time of symptom disappearance

    daily

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

    daily (7days)

Study Arms (3)

Placebo

EXPERIMENTAL

Placebo (encapsulated starch + lactose)

Drug: Placebo

SCRT(Socheongryong-tang )

EXPERIMENTAL

encapsulated Socheongryong-tang extract

Drug: SCRT

YPS (Yeongyopaedok-san)

EXPERIMENTAL

Encapsulated Yeongyopaedok-san extract

Drug: YPS

Interventions

SCRTDRUG

4 capsules,three times daily, for 7days or within symptom disappearance

Also known as: Xiao-qing-long-tang
SCRT(Socheongryong-tang )
YPSDRUG

4 capsules, three times daily, for 7days or within symptom disappearance

Also known as: Lian-qiao-bai-du-san
YPS (Yeongyopaedok-san)
PlaceboDRUG

4 capsules, three times daily, for 7days or within symptom disappearance

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \~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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

sho-seiryu-to

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • YangChun Park, Ph. D.

    Daejeon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

April 6, 2012

Record last verified: 2012-04