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

Phase 3

Terminated

• Conditions: Upper Respiratory Tract Infections; Common Cold
• Interventions: Dietary Supplement: IQP-AS-105; Dietary Supplement: Placebo

• Registration Number: NCT01964885
• Lead Sponsor: InQpharm Group

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IQP-AS-105	IQP-AS-105	One tablet daily
Placebo	Placebo	One tablet daily

Primary Outcome Measures

Name	Time	Method
Difference in severity of common cold symptoms for cold episodes between the two arms	12 weeks	Assessed by WURSS-21

Secondary Outcome Measures

Name	Time	Method
Day and score value of the maximal WURSS-21 daily score	12 weeks
Changes in special laboratory parameters in the subgroup	7 days
Incidence of cold episodes	12 weeks
global evaluation of the benefit by the subjects / investigators	12 weeks
Incidence of viral infection	12 weeks
Severity of cold symptoms at recurring (subsequent) episodes	12 weeks
Duration of cold episodes	12 weeks
Severity of cold symptoms over the first 7 days of the episode	12 weeks
Severity of cold symptoms over the first 4 days of the episode	12 weeks
Use of rescue medication	12 weeks
Number of re-infections	12 weeks
Severity of cold episodes during the 4 week follow-up period	12 weeks
Changes in cytokine production in the subgroup	7 days
Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter	12 weeks
Number of days on sick leave related to cold episodes	12 weeks
Severity of cold symptoms at first episode	12 weeks
Global assessment of tolerability by subjects/investigators	12 weeks

Trial Locations

Locations (1)

Udo Bongartz; 🇩🇪 Berlin, Germany