NCT01396889

Brief Summary

Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
Last Updated

July 22, 2011

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

July 18, 2011

Last Update Submit

July 20, 2011

Conditions

Upper Respiratory Tract Infections

Keywords

Upper Respiratory Tract InfectionsEchinaceaviral infections

Outcome Measures

Primary Outcomes (1)

  • occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary

    6 months

Secondary Outcomes (1)

  • Drug side effects

    6 months

Study Arms (2)

Echinacea

EXPERIMENTAL

0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months

Drug: Echinacea

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EchinaceaDRUG

0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old

Also known as: American Cone Flower
Echinacea
PlaceboDRUG

Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months

Placebo

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Childrens 1-5 years old

You may not qualify if:

  • Wheezing in previous 3 months requiring bronchodilatator
  • History of hyperactive reactive airway
  • using steroid or Echinacea
  • chronic pulmonary of cardiac disease
  • Acute respiratory disease within one week before study
  • Allergic rhinitis
  • Allergy to Echinacea
  • avoiding to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, Iran

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsVirus Diseases

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Roya Firoozi, Resident

    Hormozgan University of Medical Sciences (HUMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

July 22, 2011

Record last verified: 2010-05

Locations

IR(1)