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Completed

NCT Number: NCT00231218

Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

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Key information

Conditions

Common Cold Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 3-6

Exclusion criteria

  • Cystic fibrosis
  • Immunodeficiency
  • Bronchopulmonary dysplasia
  • Anatomic abnormalities of respiratory tract
  • Intestinal malabsorption
  • Allergy to sunflower seeds

Treatment and study plan

dietary supplement--echinacea, propolis, and vitamin c

Drug

Primary outcomes

  1. upper respiratory tract infections

Secondary outcomes

  1. gastroenteritis

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study

Important dates

Study start
2006
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Dec 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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