Impact of Echinacea as Prophilaxis for Upper Respiratory... | NCT01396889

Studies
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years

NCT01396889

Sponsor

Hormozgan University of Medical Sciences

Status

Completed

Last Update Posted

Jul 22, 2011Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Upper Respiratory Tract Infections

Interventions

Echinacea
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 18, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Echinacea	Drug	0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old	Echinacea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Drug side effects		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Childrens 1-5 years old

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roya Firoozi, Resident	Hormozgan University of Medical Sciences (HUMS)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hormozgan University of Medical Sciences (HUMS)		Bandar Abbas	Hormozgan		Iran

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections
D014777	Virus Diseases

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718679	Echinacea extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided