Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010465
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2001-02-02
Brief Title:
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections otitis media
Detailed Description:
Acute otitis media inflammation of the middle ear occurs in 60 of infants during the first year of life and in 85 by age 3 Approximately 17 of children suffer recurrent otitis media during the first year of life Following acute otitis media middle ear fluid effusions can persist for weeks to months Approximately 40 of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion Since antibiotic use has become widespread concern has emerged regarding antibiotic resistant S pneumoniae strains and other bacteria Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion The prevalence of pediatric use of complementary alternative medical CAM approaches for prevention of otitis media has not been widely quantified This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50AT000008-01 | NIH | None | httpsreporternihgovquickSearch1P50AT000008-01 |