Effects of Echinacea in Children
Ključne riječi
Sažetak
Opis
This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.
Datumi
| Posljednja provjera: | 11/30/2008 |
| Prvo podneseno: | 10/13/2008 |
| Predviđena prijava poslana: | 10/13/2008 |
| Prvo objavljeno: | 10/15/2008 |
| Posljednje ažuriranje poslano: | 11/29/2015 |
| Posljednje ažuriranje objavljeno: | 12/01/2015 |
| Stvarni datum početka studija: | 10/31/2008 |
| Procijenjeni datum primarnog završetka: | 04/30/2009 |
| Procijenjeni datum završetka studije: | 07/31/2009 |
Stanje ili bolest
Intervencija / liječenje
Biological: 1. Echinacea purpurea
Other: 2. placebo
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Active Comparator: 1. Echinacea purpurea | Biological: 1. Echinacea purpurea 10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods |
| Placebo Comparator: 2. placebo | Other: 2. placebo 10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 6 Years Do 6 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: - Healthy children 6-11 years old - Parent/Caregiver who can read and speak English - One child per family Exclusion Criteria: - History of allergic reaction to Echinacea or related species - History of asthma - History of allergic rhinitis - History of autoimmune disease |
Ishod
Primarne mjere ishoda
1. TNF levels [During first course of study medication]
Sekundarne mjere ishoda
1. CD25/CD69 activation [120 days]
2. IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels [120 days]
3. specific and general adverse events [120 days]
