Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Male and female nurses and nursing auxiliaries working night shift

• Age range: 20 to 45 inclusive

• BMI range: 18-30

• Negative pregnancy test for females

• Subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures

• Clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator

• Negative urine drug screen for drugs at screening

• Subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules

Exclusion Criteria:

• Any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication

• Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)

• Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic Manual, Version IV (DSM-IV)

• Individuals drinking more that 6 cups of coffee or tea/day

• Individuals smoking more than 10 cigarettes/day

• Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine Device (IUD), sterilization)

• Pregnancy and/or lactation

• Relevant allergy or known hypersensitivity to the investigational product or its excipients

• Individuals taking or having taken recently other vitamins and minerals supplementation

• Individuals with a current disorder likely to modify EEG recordings and/or computerized cognitive testing

• Individuals having a history of cancer

• Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial

• Individuals without health insurance