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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02215681
Other study ID # 031-13-ziv
Secondary ID
Status Recruiting
Phase N/A
First received July 9, 2014
Last updated August 12, 2014
Start date June 2014
Est. completion date June 2016

Study information

Verified date July 2014
Source Ziv Hospital
Contact PETER Gilbey, MD
Phone 972-4-6828883
Email peter.g@ziv.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control. 50 Children in the acupuncture group will receive standard treatment combined with acupuncture for 3 months. 50 Children in the control group will receive standard treatment only, for the same time period. After 3 months, both groups will be reassessed for OME. Children with no improvement from both groups will be assigned for tympanostomy.

Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be collected, analyzed and evaluated for group differences.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 8 Years
Eligibility Inclusion Criteria:

- otherwise healthy children ages 2-8 years

- autoscopic OME diagnosis

- tympanometry type B

- conductive hearing impairment of 30 decibel or more

- who are at watchful waiting treatment for 3 months

- signed parental consent.

Exclusion Criteria:

- lack of parental consent

- known coagulopathy

- past tympanostomy

- regular intake of steroids or cytotoxic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
acupuncture


Locations

Country Name City State
Israel Ziv Medical Center Zefat

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other acupuncture acceptance 3 months No
Primary presence of inflammatory markers in middle ear effusion after 3 months, patients in both groups will be reevaluated for OME by micro otoscopy and tympanometry, including an audiogram. patients with no improvement, will be submitted for tympanostomy in accordance with standard criteria. middle ear effusion will be collected and analysed by ELISA for viral/bacterial RNA presence and flow cytometry for leukocyte presence. results will be statistically processed for between group differences. 3 months No
Secondary acupuncture effect on OME after 3 months, patients from both group will undergo micro otoscopy,tympanometry and an audiogram to evaluate OME presence. group differences will be statistically processed 3 months No
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