To assess the efficacy and safety of Pharmaton® PHL 00749 in improving cognitive function and alleviating mental and physical stress in healthy male and female subjects leading demanding lifestyles.

Condition	Intervention	Phase
Mental Competency Mental Fatigue	Drug: Pharmaton PHL 00749  Drug: Placebo	Phase III

Further Study Details: 

Primary Outcomes: 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.
Secondary Outcomes: Secondary Endpoints: 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. The baseline (day 0 pre-dose) adjusted change scores at day 28 in the CDR factors
Expected Total Enrollment:  400

This is a double-blind, placebo-controlled, randomised, parallel group trial in healthy male and female subjects in regular employment. The duration of dosing will be 28 (+/- 1) days and assessments will 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, multimineral + Paullinia cupana extract PC102 75 mg (Guarana) or placebo] from the pharmacy at the investigational 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..

Study Hypothesis:

H0: No 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.

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 accordingly. The statistical testing will be carried out at the 0.05 level of significance. The test will be performed two-tailed.

Comparison(s):

The comparator is a matching placebo film-coated tablet without active ingredients.

Ages Eligible for Study:  20 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA Healthy male and female subjects in regular employment, aged between 20 and 50 years.

Subjects who give written informed consent in accordance with GCP and local legislation.

EXCLUSION CRITERIA Subjects who present with clinical depression. Subjects showing evidence of dementia. Clinically relevant abnormalities in medical history or examination. Subjects who have participated in a clinical study within 3 months prior to the start of the study.

History of drug and/or alcohol abuse. Subjects who smoke more than 10 cigarettes per day. Subjects who in the opinion of the Investigator are heavy users of other tobacco or nicotine products (e.g. snuff, chewing tobacco, nicotine patches, nicotine gum, etc.).

Subjects who have a history of food and/or drug allergies relevant to the study compound.

Clinically relevant deviation from normal of any finding during pre-study medical screening.

Subjects who are unable to perform the cognitive tests. Subjects currently taking a cognition enhancing substance, including any Ginkgo, ginseng or guarana product.

Any subject regularly taking a medication who might stop doing so at some time during the active dosing phase.

Pregnant or lactating women or female subjects of child-bearing potential not using adequate means of birth control (condoms, contraceptive pills, IUDs, sterilisation).

Subjects already taking other multi-vitamin products during the last 2 weeks. Healthy subjects who are regularly taking drugs which act on the Central Nervous System (CNS).

United Kingdom
      Southlea Surgery, Aldershot,  GU11 3RB,  United Kingdom

Study chairs or principal investigators

Sheila Campbell,  Study Chair,  Pharmaton   

Study ID Numbers:  1232.1
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144235
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2005-09-13