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

InQpharm

Status and phase: Terminated; Phase 3

Conditions: Upper Respiratory Tract Infections; Common Cold

Treatments: Dietary Supplement: IQP-AS-105; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964885

INQ/012213

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

IQP-AS-105

Active Comparator group

Description:

One tablet daily

Treatment:

Dietary Supplement: IQP-AS-105

Placebo

Placebo Comparator group

Description:

One tablet daily

Treatment:

Dietary Supplement: Placebo