Clinical Trials Logo

Clinical Trial Summary

This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.


Clinical Trial Description

Upper respiratory tract infections (URI's) are a significant health burden in childhood. URI's are a major reason for visits to health care providers, and up to 35 percent of young children at any given time are taking some over-the-counter cold medication. Unfortunately, data suggest that most of these medications have limited effectiveness. Alternative medical therapies are growing in popularity; in a recent survey of parents of children being seen by pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen by an alternative medicine health care provider, and 53.3 percent received therapies for the treatment of URI's in children. The proposed study is a randomized, double blind, placebo controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims of the project are: to determine if Echinacea shortens the duration and/or lessens the severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11 years old is associated with any significant side effects. A two-year study of 600 children is planned. Not only will the results of this study determine if Echinacea, the most popular medicinal herb sold in the United States, is an effective therapy for URI's in children, the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00029211
Study type Interventional
Source National Center for Complementary and Integrative Health (NCCIH)
Contact
Status Completed
Phase Phase 3
Start date April 2000
Completion date March 2003

See also
  Status Clinical Trial Phase
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT02451163 - DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly Phase 2
Completed NCT01944631 - Iota-Carrageenan Nasal Spray in Common Cold Phase 4
Completed NCT01651715 - Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections Phase 1/Phase 2
Completed NCT00963443 - Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold Phase 3
Completed NCT00778648 - Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms N/A
Completed NCT00065715 - Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) Phase 3
Completed NCT00032500 - Evaluation of Echinacea for the Common Cold Phase 2
Not yet recruiting NCT05070650 - Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold Phase 3
Not yet recruiting NCT04073511 - Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold N/A
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Completed NCT03189537 - Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections Phase 3
Terminated NCT01964885 - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections Phase 3
Completed NCT01277081 - Effect of Paracetamol on the Common Cold Phase 2
Completed NCT01728090 - Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections Phase 4
Completed NCT00405509 - The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years N/A
Completed NCT01033526 - Symptomatic Treatment of Common Cold Symptoms Phase 4
Completed NCT05556148 - Otrivine: Quality of Life (QoL) Impact in a Real-World Setting Phase 4
Terminated NCT03339726 - Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold Phase 2
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3