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 SUMMARY
OF THE STUDY
- Objective
: evaluation of the efficacy of KAROSHIL® on mild anxiety,
benign mood disorders, quality of life and wellbeing, under double-blind,
placebo-controlled conditions.eral criteria for evaluation were
retained during the study.
- Population : 60 subjects (39 women and 21 men) aged 19
to 54 years.
- Duration : 9 weeks - including an inclusion visit, 4 evaluation
visits (week 1, week 5 and week 9), and an end-of-study visit.
- Administration : 4 tablets per day for 9 weeks.
RESULTS
:
SAFETY:
both clinical and laboratory safety were shown to be excellent RESULTS
at the END of treatment (end of week 9) with KAROSHL®
NB/CONCLUSIONS
The
majority of the evaluations showed a more significant
overall improvement with KAROSHIL® than
with placebo, although a strong placebo effect was evidenced,
as is typical in this type of study population.
Very marked results were observed as early as the end
of week 1 for subjects receiving KAROSHIL®. These
results then improved more slowly, but continuously, until
week 9. |
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DOUBLE
BLIND STUDY CONCLUSIONS
Several
criteria for evaluation were retained during the study.
CLINICAL
AND LABORATORY SAFETY :
In view of
the study population and the duration of the study, the clinical
and laboratory safety of KAROSHIL® were shown to be very
satisfactory.
 IMPROVEMENT
IN THE VARIOUS PARAMETERS :
The
majority of the evaluations showed an improvement in the parameters
retained, evidencing a "strong placebo effect", which is typically
observed in this type of study population.
It should also be stressed that, for obvious ethical reasons, the
inclusion protocol was written according to extremely strict guidelines,
providing for the exclusion of tests involving genuinely disturbed
individuals.
COMMENTS
:
Subjects
receiving treatment with KAROSHIL®
described themselves as "more energetic, more alert, more responsive,
and more capable while being more relaxed, more sociable, friendlier
and happier. "In subjects receiving treatment with KAROSHIL®,
a greater improvement in anxiety and sleep disorders was noted,
which would seem to support the terms "more relaxed" or "calmer"
observed in the Norris and Hamilton test. Similarly, mood disorders
and social dysfunction in the GHQ-28 test showed markedly
greater improvement with KAROSHIL®,
which again supports the feelings of being "more sociable", "friendlier"
or "happier" observed in the Norris test. Lastly, the third evaluation
of quality of life, carried out using Pichot's ADA questionnaire,
once again shows a better outcome with KAROSHIL®
on each visit.
To
summarise, the different multi-parametric tests used to
evaluate quality of life, wellbeing and anxiety demonstrate
a more significant overall
improvement with KAROSHIL®
than with placebo.
This improvement mainly relates to social function, anxiety,
quality of life, wellbeing, and mood in general.
Very marked results were observed as early as the end
of week 1 for subjects receiving KAROSHIL®.
These results then improved more slowly, but continuously,
until week 9. |
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