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

August 9, 2011
August 10, 2011
October 2009
February 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01414335 on ClinicalTrials.gov Archive Site
outcome of efficacy [ Time Frame: 3 month treatment ] [ Designated as safety issue: No ]
Secondary outcome variables: feel the patient fit and able-bodied.
Same as current
Not Provided
Not Provided
 
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo
  • 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
  • Other: Placebo
    placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
    Other Names:
    • remedy
    • placebo
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
  • Active Comparator: amino acid composition
    Intervention: Dietary Supplement: amino acid composition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
September 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01414335
Kyb10/09
No
Sponsor: Kyberg Vital GmbH
Kyberg Vital GmbH
Not Provided
Not Provided
Kyberg Vital GmbH
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP