NCT00947986

Brief Summary

The investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 22, 2010

Status Verified

March 1, 2010

Enrollment Period

7 months

First QC Date

July 28, 2009

Last Update Submit

March 18, 2010

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Change in mucociliary clearance time (MCT)

    4 weeks

Study Arms (1)

Johnson's Baby Shampoo

EXPERIMENTAL

1% diluted solution

Other: 1% Johnson's Baby Shampoo

Interventions

1% Johnson's Baby ShampooOTHER

nasal irrigation 2x a day for 4 weeks

Johnson's Baby Shampoo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CRS
  • s/p sinus surgery

You may not qualify if:

  • nasal polyps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Department of Otolaryngology Clinic

Houston, Texas, 77030, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 22, 2010

Record last verified: 2010-03

Locations

US(1)