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

• Status: Completed
• Trial end date: 2019-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: A. Vogel AG; Bioforce AG
• Collaborators: Cantonal Hospital of St. Gallen; Labormedizinisches Zentrum Dr. Risch

Criteria

Inclusion Criteria:

• At least 18 years old

• Signed Informed Consent

Exclusion Criteria:

• Younger than 18 years

• Participation in another clinical study in the past 30 days

• Permanent intake of antimicrobial, antiviral, immune suppressive substances

• Surgical intervention in the 3 months prior to inclusion or planned surgery during period of observation

• 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

• At inclusion known pregnancy or planned pregnancy during period of investigation (required: active contraception for women of childbearing year)