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

This study has been terminated.
(No significant results during interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01964885
First Posted: October 17, 2013
Last Update Posted: February 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InQpharm Group
  Purpose
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

Condition Intervention Phase
Common Cold Upper Respiratory Tract Infections Dietary Supplement: IQP-AS-105 Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Difference in severity of common cold symptoms for cold episodes between the two arms [ Time Frame: 12 weeks ]
    Assessed by WURSS-21


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

Enrollment: 140
Study Start Date: October 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IQP-AS-105
One tablet daily
Dietary Supplement: IQP-AS-105
Placebo Comparator: Placebo
One tablet daily
Dietary Supplement: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964885


Locations
Germany
Udo Bongartz
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Udo Bongartz, PhD
  More Information

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01964885     History of Changes
Other Study ID Numbers: INQ/012213
First Submitted: October 15, 2013
First Posted: October 17, 2013
Last Update Posted: February 12, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Disease Susceptibility
Common Cold
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases