Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144235
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2005-09-02
Brief Title:
Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A 28 Day Randomised Double-blind Placebo-controlled Single-centre Trial to Evaluate the Efficacy and Safety of Pharmaton PHL 00749 Film Coated Tablets G115 40 mg Multivitamin Multimineral Guarana 75 mg 1Day po in Improving Mental Performance and to Decrease Fatigue in Healthy Male and Female Subjects in Regular Employment
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 21
Study Hypothesis
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 005 level of signifi cance The test will be performed two-tailed
Comparisons
The comparator is a matching placebo film-coated tablet without active ingredien ts
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 21
Study Hypothesis
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 005 level of signifi cance The test will be performed two-tailed
Comparisons
The comparator is a matching placebo film-coated tablet without active ingredien ts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None