Echinacea Junior vs Vitamin C in Children 4-12 Years Old

• ClinicalTrials.gov Identifier: NCT02971384
• Recruitment Status: Completed
• First Posted: November 23, 2016
• Last Update Posted: May 4, 2021
• Sponsor: A. Vogel AG
• Information provided by (Responsible Party): A. Vogel AG

Tracking Information

• First Submitted Date: November 16, 2016
• First Posted Date: November 23, 2016
• Last Update Posted Date: May 4, 2021
• Actual Study Start Date: November 25, 2016
• Actual Primary Completion Date: August 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2017)

cumulative number of cold days [ Time Frame: 4 months prevention ]

total number of days with cold symptoms as per diary entries

Original Primary Outcome Measures (submitted: November 18, 2016)

• Occurrence of adverse events [ Time Frame: 4 months prevention ]
  Occurrence of adverse Events will be analysed by descriptive methods
• Occurrence of adverse drug reactions [ Time Frame: 4 months prevention ]
  Occurrence of adverse Events will be analysed by descriptive methods
• Tolerability in view of the physician [ Time Frame: After 4 months prevention ]
  physicians will judge tolerability as "bad", "moderate", "good" or "very good"
• Tolerability in view of the participant [ Time Frame: 4 moths prevention ]
  parents will judge the tolerability after 2 and 4 months treatment
• Acceptance in the view of the parents [ Time Frame: 4 months prevention ]
  parent will judge the tolerability after 4 months
• accompanying virus analytics [ Time Frame: 4 months prevention ]
  nasal samples will be taken at occurrence of cold Symptoms and will be descriptively analysed for the presence of respiratory viruses
• descriptive Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score) [ Time Frame: 4 months prevention ]
  Patients will rate respiratory Symptoms in a diary at occurrence of acute respiratory tract infections and the entries will analysed descriptively for the two Treatment groups
• Tolerability in the view of the participant [ Time Frame: 4 months prevention ]
  Parents will consider their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
• effects on the endogenous defense [ Time Frame: 4 months prevention ]
  Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")

Current Secondary Outcome Measures (submitted: December 22, 2017)

• Occurrence of adverse events [ Time Frame: 4 months prevention ]
  Occurrence of adverse events will be analysed by descriptive methods
• Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score) [ Time Frame: 4 months prevention ]
  Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups
• Incidence of respiratory tract infections (viral RTIs) [ Time Frame: 4 months prevention ]
  Occurrence of colds and flu episodes
• Acceptance in the view of the parents [ Time Frame: 4 months prevention ]
  Parents will judge the acceptance after 4 months (would you use the medicament again?)
• Occurrence of adverse drug reactions [ Time Frame: 4 months prevention ]
  Occurrence of adverse drug reactions will be analysed by descriptive methods
• Tolerability in view of the physician [ Time Frame: 4 months prevention ]
  physicians will judge tolerability as "bad", "moderate", "good" or "very good"
• Tolerability in view of the parents [ Time Frame: After 4 months prevention ]
  parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
• Efficacy in the view of the parents/children [ Time Frame: 4 months prevention ]
  Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
• accompanying virus analytics [ Time Frame: 4 months prevention ]
  nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
• effects on the endogenous defense [ Time Frame: 4 months prevention ]
  Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")
• Concomitant treatment and therapies [ Time Frame: 4 months prevention ]
  Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Echinacea Junior vs Vitamin C in Children 4-12 Years Old
• Official Title: Controlled, Randomized, Double-blind, Multicentre Study on Efficacy and Safety of Echinaforce Junior Tablets in Comparison With Vitamin C for the Prevention of Viral Respiratory Tract Infections in Children (4-12 Years)
• 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.

Detailed Description

200 children aged 4-12 years are recruited by pediatricians and general practitioners and are allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C. Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment break and an intermediate study visit (V2). Thereafter children continue with preventive Treatment for another 2 months, followed by exclusion visit (V3).

Parents are required to contact a study coordinator at the occurrence of acute respiratory Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode parents will sample nasal secretion, which will be analysed for common respiratory agents.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Tract Infection Viral

Intervention

Drug: Echinaforce

Other Name: Echinacea purpurea

Study Arms

• Experimental: Echinaforce Junior Tablets
  Hydroalcoholic extract of Echinacea purpurea herb and radix
  Intervention: Drug: Echinaforce
• Active Comparator: Vitamin C Tablets
  synthetically produced ascorbic acid
  Intervention: Drug: Echinaforce

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2021): 203
• Original Estimated Enrollment (submitted: November 18, 2016): 200
• Actual Study Completion Date: July 3, 2018
• Actual Primary Completion Date: August 3, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 4-12 years
• written informed consent by parents and optionally by child
• daily Access to computer/email
• german language skills

Exclusion Criteria:

• 13 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)
• surgical intervention 3 months Prior to inclusion or planned intervention during the observation period
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02971384
• Other Study ID Numbers: 5000120
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: A. Vogel AG
• Original Responsible Party: Same as current
• Current Study Sponsor: A. Vogel AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mercedes Ogal, Dr. med.; Arztpraxis für Kinder und Jugendliche

• PRS Account: A. Vogel AG
• Verification Date: December 2017