Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
1 other identifier
interventional
145
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedAugust 11, 2011
August 1, 2011
4 months
August 9, 2011
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 month treatment
Secondary Outcomes (1)
outcome of efficacy
3 month treatment
Study Arms (2)
placebo
PLACEBO COMPARATORamino acid composition
ACTIVE COMPARATORInterventions
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.
placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
Eligibility Criteria
You may qualify if:
- men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyberg Vital - Doris Meister
Oberhaching, Bavaria, 82041, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 11, 2011
Study Start
October 1, 2009
Primary Completion
February 1, 2010
Study Completion
September 1, 2010
Last Updated
August 11, 2011
Record last verified: 2011-08