Improved immune defense by a proprietary larch arabinogalacta

Not Applicable

Completed

• Conditions: Immune function; Infections and Infestations; Acute upper respiratory infections

• Registration Number: ISRCTN41183655
• Lead Sponsor: onza Ltd (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age 18 - 70 years (child-bearing females had to agree to use appropriate birth control methods)
2. Recurrent infections of upper airways (at least 3 episodes in half-year according to subject?s statement)
3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply

Exclusion Criteria

1. Acute infection of the upper airways
2. Chronic upper airways disease (e.g. chronic bronchitis or asthma)
3. Suspected influenza or swine flu
4. Body temperature above 38°C
5. Vaccination against influenza or swine flu within 21 days before study start
6. Serious organ or systemic diseases
7. Body mass index above 30
8. Clinically significant abnormal laboratory parameters (values outside of reference range)
9. Known sensitivity to the ingredients of the investigational product
10. Inborn or acquired immune deficiency disease (e.g. HIV infection)
11. Pregnancy and nursing
12. Use of following medication:
12.1. Immunosuppressive agents
12.2. Immunostimulating agents, e.g. Echinacea
12.3. Local oral and pharyngeal treatment
12.4. Antibiotics within 14 days before study start
13. Drugs, alcohol and medical abuse
14. Use of prebiotics and probiotics (e.g. yogurt, drinks, supplements)
15. Participation in another clinical study at or within 30 days before study start
16. Inability to comply with study requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of cold episodes during the study period

Secondary Outcome Measures

Name	Time	Method
1. Duration of cold episodes (based on subject diary)<br>2. Episode intensity assessed per change of the total sum score after 5 days compared to start of episode (first Episode Visit), based on case report form (CRF) and subject diary<br>3. Episode intensity at start of episode (sum score on Day 1 based on subject diary, i.e. at first Episode Visit based on CRF)<br>4. Global assessment of efficacy and tolerability<br>5. Assessment of adverse events<br>6. Assessment of laboratory parameters including leucocyte differentiation<br>7. Assessment of eating habits based on a 3-day-record