Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and allevi ating mental and physical stress in healthy male and female subjects leading demanding lifestyles.
Drug: Pharmaton PHL 00749
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A 28 Day Randomised, Double-Blind, Placebo-Controlled, Single Centre Trial to Evaluate the Efficacy in Improving Mental Performance and Decrease Fatigue in Healthy Male and Female Subjects in Regular Employment|
- Primary Endpoint: The baseline (day 0 pre-dose) adjusted change in the CDR Factor, Power of Attention, at day 28 averaged over the 4 and 6 hour post-dosing time points.
- The baseline (day 0 pre dose) adjusted change in the CDR Factor, Power of Attention, at day 0 averaged over the 4 and 6 hour post dosing time points.
|Estimated Study Completion Date:||July 2005|
This is a double-blind, placebo-controlled, randomised, parallel group trial in healthy male and fem ale subjects in regular employment. The duration of dosing will be 28 '(+/- 1)' days and assessments w ill be made on two visits (visits 2 and 3) with a training on the CDR system at the screening visit.
The subjects will receive one bottle with 35 tablets [of either Ginseng G115 40 mg, multivitamin, mu ltimineral '+' Paullinia cupana extract PC102 75 mg (Guarana) or placebo] from the pharmacy at the in vestigational site. The subjects should take the study drug from day 0 to day 28 '(+/- 1)' Subjects will be assigned to one of the two treatment groups randomly. The allocation ratio is 2:1..
H0: No difference exists between the treatment and the placebo groups in terms o f baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour time point. H1: A difference exists between the treatment and the placebo groups in terms of baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour time point. The null and alternative hypotheses for the secondary endpoints are set up accor dingly. The statistical testing will be carried out at the 0.05 level of signifi cance. The test will be performed two-tailed.
The comparator is a matching placebo film-coated tablet without active ingredien ts.
|Boehringer Ingelheim Investigational Site|
|Aldershot, United Kingdom, GU11 3RB|
|Study Chair:||Boehringer Ingelheim Study Coordinator||Pharmaton|