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Evaluating the Clinical Efficacy and Safety of Colflex

U

University of Manitoba

Status

Completed

Conditions

Personal Satisfaction

Study type

Observational

Funder types

Other

Identifiers

NCT02011035
B2013:133

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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