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

to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414335
• Other study ID #: Kyb10/09
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: August 10, 2011
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: Kyberg Vital GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo

Intervention

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:
• Placebo
placebo contained no amino acids and vitamins and was identical in appearance and solution properties.

Locations

Country	Name	City	State
Germany	Kyberg Vital - Doris Meister	Oberhaching	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Kyberg Vital GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	outcome of efficacy	Secondary outcome variables: feel the patient fit and able-bodied.	3 month treatment	No