Back to resultsAmino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
Primary Purpose
to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
amino acid composition
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo focused on measuring amino acids, immune system, vitamins, chronic infection, common cold, ear, nose, throat
Eligibility 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
Sites / Locations
- Kyberg Vital - Doris Meister
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
amino acid composition
Arm Description
Outcomes
Primary Outcome Measures
outcome of efficacy
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
Secondary outcome variables: feel the patient fit and able-bodied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01414335
Brief Title
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
Official Title
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyberg Vital GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo
Keywords
amino acids, immune system, vitamins, chronic infection, common cold, ear, nose, throat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
amino acid composition
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
amino acid composition
Other Intervention Name(s)
Brand name: aminoplus immun
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
remedy
Intervention Description
placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
Primary Outcome Measure Information:
Title
outcome of efficacy
Description
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.
Time Frame
3 month treatment
Secondary Outcome Measure Information:
Title
outcome of efficacy
Description
Secondary outcome variables: feel the patient fit and able-bodied.
Time Frame
3 month treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Kyberg Vital - Doris Meister
City
Oberhaching
State/Province
Bavaria
ZIP/Postal Code
82041
Country
Germany
12. IPD Sharing Statement
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Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
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