Trial record 7 of 21 for:    Open Studies | "Common Cold"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by InQpharm Group
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01964885
First received: October 15, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Assessed by WURSS-21


Secondary Outcome Measures:
  • Incidence of cold episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of cold episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold symptoms over the first 4 days of the episode [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold symptoms over the first 7 days of the episode [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Day and score value of the maximal WURSS-21 daily score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of viral infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of days on sick leave related to cold episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of re-infections [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold symptoms at first episode [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold symptoms at recurring (subsequent) episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of cold episodes during the 4 week follow-up period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in special laboratory parameters in the subgroup [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Changes in cytokine production in the subgroup [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • global evaluation of the benefit by the subjects / investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global assessment of tolerability by subjects/investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 312
Study Start Date: October 2013
Estimated Study Completion Date: May 2014
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964885

Contacts
Contact: Udo Bongartz, PhD +49 30/306 40 20 ubongartz@analyze-realize.com

Locations
Germany
Udo Bongartz Recruiting
Berlin, Germany, 10369
Contact: Udo Bongartz, PhD    +49 30/306 40 20 543    ubongartz@analyze-realize.com   
Principal Investigator: Udo Bongartz, PhD         
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Udo Bongartz, PhD
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01964885     History of Changes
Other Study ID Numbers: INQ/012213
Study First Received: October 15, 2013
Last Updated: October 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 28, 2014