Common Cold, Upper Respiratory Tract Infections
Conditions
Brief summary
IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive medicine, based on its ability to enhance the immune system responses
Interventions
DIETARY_SUPPLEMENTIQP-AS-105
DIETARY_SUPPLEMENTPlacebo
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-70 years * increased risk for infections - at least 4 cold episodes within 12 months * commitment to adhere to their accustomed diet and physical activity * women of child-bearing potential have to agree to use appropriate birth control methods * written consent of the subject to participate is a prerequisite for study participation
Exclusion criteria
* acute / chronic upper airways disease * chronic cough of any origin * acute / chronic lower airways disease * any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis) * history of nasal reconstructive surgery * presence of nasal ulcers or nasal polyps * severe nasal septum deviation or other condition that could cause nasal obstruction * congenital or acquired immunodeficiency disease (e.g. HIV infection) * severe organ or systemic diseases * body temperature above 37.5°C * suspected swine flu or influenza * vaccination against influenza or swine flu within 3 months prior to study start * stomach/gastrointestinal diseases * sleep disorder * psychiatric disorders * known sensitivity to the ingredients of the investigational product * intake of products that may influence the study outcome within the last 14 days prior to study start and during the study * analgesics , antibiotics or decongestant nose drops/spray, unless they are used as rescue medications * pregnancy or nursing * alcohol / drug abuse * simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days * insufficient compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in severity of common cold symptoms for cold episodes between the two arms | 12 weeks | Assessed by WURSS-21 |
Secondary
| Measure | Time frame |
|---|---|
| Duration of cold episodes | 12 weeks |
| Severity of cold symptoms over the first 4 days of the episode | 12 weeks |
| Severity of cold symptoms over the first 7 days of the episode | 12 weeks |
| Day and score value of the maximal WURSS-21 daily score | 12 weeks |
| Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter | 12 weeks |
| Incidence of viral infection | 12 weeks |
| Use of rescue medication | 12 weeks |
| Number of days on sick leave related to cold episodes | 12 weeks |
| Incidence of cold episodes | 12 weeks |
| Severity of cold symptoms at first episode | 12 weeks |
| Severity of cold symptoms at recurring (subsequent) episodes | 12 weeks |
| Severity of cold episodes during the 4 week follow-up period | 12 weeks |
| Changes in special laboratory parameters in the subgroup | 7 days |
| Changes in cytokine production in the subgroup | 7 days |
| global evaluation of the benefit by the subjects / investigators | 12 weeks |
| Global assessment of tolerability by subjects/investigators | 12 weeks |
| Number of re-infections | 12 weeks |
Countries
Germany
Outcome results
None listed