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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01964885
Other study ID # INQ/012213
Secondary ID
Status Terminated
Phase Phase 3
First received October 15, 2013
Last updated February 10, 2016
Start date October 2013
Est. completion date May 2014

Study information

Verified date February 2016
Source InQpharm Group
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 140
Est. completion date May 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
IQP-AS-105

Placebo


Locations

Country Name City State
Germany Udo Bongartz Berlin

Sponsors (1)

Lead Sponsor Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in severity of common cold symptoms for cold episodes between the two arms Assessed by WURSS-21 12 weeks No
Secondary Incidence of cold episodes 12 weeks No
Secondary Duration of cold episodes 12 weeks No
Secondary Severity of cold symptoms over the first 4 days of the episode 12 weeks No
Secondary Severity of cold symptoms over the first 7 days of the episode 12 weeks No
Secondary Day and score value of the maximal WURSS-21 daily score 12 weeks No
Secondary Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter 12 weeks No
Secondary Incidence of viral infection 12 weeks No
Secondary Use of rescue medication 12 weeks No
Secondary Number of days on sick leave related to cold episodes 12 weeks No
Secondary Number of re-infections 12 weeks No
Secondary Severity of cold symptoms at first episode 12 weeks No
Secondary Severity of cold symptoms at recurring (subsequent) episodes 12 weeks No
Secondary Severity of cold episodes during the 4 week follow-up period 12 weeks No
Secondary Changes in special laboratory parameters in the subgroup 7 days No
Secondary Changes in cytokine production in the subgroup 7 days No
Secondary global evaluation of the benefit by the subjects / investigators 12 weeks No
Secondary Global assessment of tolerability by subjects/investigators 12 weeks Yes
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