NCT02971384

Brief Summary

Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

November 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
Last Updated

May 4, 2021

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

November 16, 2016

Last Update Submit

May 3, 2021

Conditions

Respiratory Tract Infection Viral

Outcome Measures

Primary Outcomes (1)

  • cumulative number of cold days

    total number of days with cold symptoms as per diary entries

    4 months prevention

Secondary Outcomes (11)

  • Occurrence of adverse events

    4 months prevention

  • Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)

    4 months prevention

  • Incidence of respiratory tract infections (viral RTIs)

    4 months prevention

  • Acceptance in the view of the parents

    4 months prevention

  • Occurrence of adverse drug reactions

    4 months prevention

  • +6 more secondary outcomes

Study Arms (2)

Echinaforce Junior Tablets

EXPERIMENTAL

Hydroalcoholic extract of Echinacea purpurea herb and radix

Drug: Echinaforce

Vitamin C Tablets

ACTIVE COMPARATOR

synthetically produced ascorbic acid

Drug: Echinaforce

Interventions

EchinaforceDRUG
Also known as: Echinacea purpurea
Echinaforce Junior TabletsVitamin C Tablets

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years
  • written informed consent by parents and optionally by child
  • daily Access to computer/email
  • german language skills

You may not qualify if:

  • years or older, younger than 4 years
  • participation in a clinical study during past 30 days
  • intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin)
  • known Diabetes mellitus
  • known and treated atopy or Asthma
  • cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD)
  • diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis))
  • Metabolic or Resorption disorders
  • Liver or kidney diseases
  • Serious health Problems (e.g. neurological Problems)
  • known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. med. Mercedes Ogal

Brunnen, 6440, Switzerland

Location

Related Publications (1)

  • Ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic usage in children through respiratory tract infection prevention: a randomized, blinded, controlled clinical trial. Eur J Med Res. 2021 Apr 8;26(1):33. doi: 10.1186/s40001-021-00499-6.

    PMID: 33832544DERIVED

MeSH Terms

Interventions

EchinaforceEchinacea extract

Study Officials

  • Mercedes Ogal, Dr. med.

    Arztpraxis für Kinder und Jugendliche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 23, 2016

Study Start

November 25, 2016

Primary Completion

August 3, 2017

Study Completion

July 3, 2018

Last Updated

May 4, 2021

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)