Evaluating the Clinical Efficacy and Safety of Colflex

NCT ID: NCT02011035

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Personal Satisfaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* availability to give written consent
* age 18-60, men and women (who are not pregnant or nursing)
* people in good health
* able to follow protocol
* must be experiencing a sore throat or cold at least once a year

Exclusion Criteria

* smokers
* liver and kidney disease
* inflammatory bowel disease
* pancreatitis
* gallbladder or biliary disease
* neurolgical/psychological disease
* bleeding disorders
* platelet abnormatilies
* gastrointestinal disorders that could interfere with fat absorption
* serum triglycerides \> 500 mg/dL and/or total cholesterol \> 300 mg/dL
* hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 Hg
* BMI \>30
* consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
* reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
* reported use of experimental medication within 1 month prior to the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Peter Jones

Director of the Richardson Centre for Functional Foods and Nutraceuticals

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RCFFN: University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2013:133

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Experimental Mouthwashes
NCT05121909 COMPLETED PHASE4
Anti-gingivitis Mouthrinse
NCT06048627 COMPLETED PHASE3