Immune function Infections and Infestations Acute nasopharyngitis [common cold]
Conditions
Interventions
Subjects were randomly assigned to receive a total of 900 mg of either Yestimun® or placebo, each provided in two capsules per day, which were consumed at breakfast and supper.
During the study perio
Sponsors
Leiber GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years (child-bearing females had to agree to use appropriate birth control methods) 2. At least three common cold infections within the last six months 3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply
Exclusion criteria
Exclusion criteria: 1. Acute infection of the upper airways (e.g. acute bronchitis) 2. Chronic upper airway disease (e.g. chronic bronchitis, tonsillitis or asthma) 3. Chronic cough of any origin 4. Chronic rhinitis (vasomotor or allergic rhinitis) 5. Congenital or acquired immunodeficiency disease (e.g. HIV infection) 6. Acute or chronic diarrhea 7. Severe organ or systemic diseases 8. Suspected swine flu or influenza 9. Body temperature above 37.5°C 10. Vaccination against influenza or swine flu within 21 days prior to study start 11. Known hypersensitivity to ingredients of the investigational product 12. Pregnancy and lactation 13. Use of immunosuppressants 14. Use of immunostimulants (e.g. Echinacea) within the last 14 days prior to study start 15. Use of antibiotics within the last 14 days prior to study start 16. Alcohol/drug abuse; drug addiction 17. Simultaneous participation in another clinical trial or participation in a clinical trial within the last 4 weeks 18. Regular use of other yeast preparations 19. Incertainty regarding compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of number of cold episodes during the study period in the Yestimun® study arm compared to placebo study arm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of cold episodes (total sum score during the entire episode) 2. Duration of cold episodes (based on subject diary) 3. Severity of colds at episode start (total score on day 1 and day 2) 4. Severity of colds on the day of the Episode Visit (CRF) 5. Use of antibiotics and analgesics (subject's diary) 6. Global assessment of efficacy and tolerability 7. Assessment of adverse events 8. Assessment of sick leave days | — |
Countries
Germany
Outcome results
None listed