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Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial

This study has been completed.
Sponsor:
Information provided by:
Kyberg Vital GmbH
ClinicalTrials.gov Identifier:
NCT01414335
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T


Condition Intervention
to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo
 Dietary Supplement: amino acid composition
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyberg Vital GmbH:

Primary Outcome Measures:
  • outcome of efficacy [ Time Frame: 3 month treatment ] [ Designated as safety issue: No ]
    For each study day,participants recorded in a diary rectal temperature, symptoms of sneezing, blocked nose or streaming eyes, whether they had problems to swollow and whether they had headache or pain in arms or legs.


Secondary Outcome Measures:
  • outcome of efficacy [ Time Frame: 3 month treatment ] [ Designated as safety issue: No ]
    Secondary outcome variables: feel the patient fit and able-bodied.


Enrollment: 145
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Other: Placebo
placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
Other Names:
  • remedy
  • placebo
Active Comparator: amino acid composition Dietary Supplement: amino acid composition
one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal.
Other Name: Brand name: aminoplus immun

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area.

Exclusion Criteria:

  • people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414335

Locations
Germany
Kyberg Vital - Doris Meister
Oberhaching, Bavaria, Germany, 82041
Sponsors and Collaborators
Kyberg Vital GmbH
  More Information

No publications provided

Responsible Party: Sponsor: Kyberg Vital GmbH
ClinicalTrials.gov Identifier: NCT01414335     History of Changes
Other Study ID Numbers: Kyb10/09
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Kyberg Vital GmbH:
amino acids
immune system
vitamins
chronic infection
 common cold
ear
nose
throat

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013