Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections

NCT03812900 | Completed Phase 2

• 1 other identifier: 5'000'155
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Time to remission from initial episodes

  duration until respiratory symptoms are solved

  maximally 10 days

Secondary Outcomes (16)

• Time to remission from overall episodes

  maximally 10 days

• Cross-comparison of remissions between formulations

  maximally 10 days

• Development of single respiratory symptoms

  maximally 10 days

• Development of respiratory symptom sum score

  maximally 10 days

• Absence from School/Work

  during acute respiratory episodes, 7 days each

Study Arms (4)

Formulation A

EXPERIMENTAL

Echinacea purpurea alcoholic extract lozenges (novel formulation)

Drug: Echinacea purpurea alcoholic extract

Formulation B

EXPERIMENTAL

Echinacea purpurea alcoholic extract spray (novel formulation)

Drug: Echinacea purpurea alcoholic extract

Formulation C

ACTIVE COMPARATOR

Echinacea purpurea alcoholic extract tablet (basic formulation, reference)

Drug: Echinacea purpurea alcoholic extract

Formulation D

ACTIVE COMPARATOR

Echinacea purpurea alcoholic extract, drops (basic formulation, reference)

Drug: Echinacea purpurea alcoholic extract

Interventions

Echinacea purpurea alcoholic extract DRUG

Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)

Formulation A; Formulation B; Formulation C; Formulation D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Signed Informed Consent

You may not qualify if:

• Younger than 18 years
• Participation in another clinical study in the past 30 days
• Permanent intake of antimicrobial, antiviral, immune suppressive substances
• Known diabetes melitus
• Known and treated atopy or asthma bronchiale
• Cystic fibrosis, bronchopulmonale dysplasia, COPD
• Known diseases of the immune system, degenerative illnesses (e.g. auto-immune disorders like AIDS or leukemia, myeloma)
• Known metabolic or resorptive disorders
• Known chronic liver diseases (chronic hepatitis, liver cirrhosis)
• Known chronic kidney insufficiency
• Serious health issues (reduced health status, autoimmune illness, tumorous illness)
• Known allergy to plants of compositae family (camomille, dandelion) or to any substances of the investigational product

Sponsors & Collaborators

• A. Vogel AG: lead
• Cantonal Hospital of St. Gallen: collaborator
• Labormedizinisches Zentrum Dr. Risch: collaborator

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Location

Related Publications (1)

• Sumer J, Keckeis K, Scanferla G, Frischknecht M, Notter J, Steffen A, Kohler P, Schmid P, Roth B, Wissel K, Vernazza P, Klein P, Schoop R, Albrich WC. Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults-A randomized blinded controlled trial. Front Med (Lausanne). 2023 Apr 17;10:948787. doi: 10.3389/fmed.2023.948787. eCollection 2023.

  PMID: 37138742 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: January 23, 2019
• Study Start: November 27, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 7, 2019
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)