There
are several types of clinical trials with different objectives
and durations. These phases have been developed specifically for
testing pharmaceutical drugs.
Phase I Trials:
The primary objective of a Phase I trial is
to define the proper dosing of a new drug or treatment and identify
side effects and safety. A Phase I trial usually enrolls only
small groups of patients (20-80).
Phase II Trials:
A Phase II trial provides information about
the benefit, further effectiveness, and safety of a new drug
or treatment. Phase II trials may focus on particular health
aspects in certain diseases, and they are conducted with larger
groups of patients (100-300).
Phase III Trials:
Phase III trials further test effectiveness
of a new drug or procedure and compare it with the current standard
therapy. Phase III trials typically involve large groups of
patients (1,000-3,000) from clinics and centers nationwide.
Phase IV Trials:
Phase IV trials are conducted after the
drug or treatment has been already marketed and is available
for general use. These trials continue to collect information
about the drug or treatment’s effect in various populations
and any side effects associated with long-term use. This trial
is also called a post- marketing surveillance study.
Contrary to drugs, which are chemical molecules
that are toxic to the body, vitamins and nutritional supplements
are natural components of our food. They are safe and, therefore,
the FDA does not require clinical testing of them. However, Matthias
Rath Company sets high scientific standards and conducts extensive
Phase I and Phase II randomized double- blind placebo-controlled
clinical trials. These trials utilize natural compounds and document
the effectiveness and safety of nutrients with and without conventional
treatment in various aspects of health.