Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections

Study Overview
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Brief Summary
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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

Official Title
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Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections

Conditions
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Common Cold, Upper Respiratory Tract Infections

Intervention / Treatment
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* Dietary Supplement: IQP-AS-105
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-AS-105<br>One tablet daily | Dietary Supplement: IQP-AS-105<br> <br> |
| Placebo Comparator: Placebo<br>One tablet daily | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in severity of common cold symptoms for cold episodes between the two arms | Assessed by WURSS-21 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cold episodes |  | 12 weeks | 
| 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 | 
| Number of re-infections |  | 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 |