Note: Descriptions are shown in the official language in which they were submitted.
21 74608
DIETARY SUPPLEMENT FOR ALLEVIATING THE SYMPTOMS
ASSOCIATED WITH ENLAR(;~ OF THE PROSTATE GLAND
BACRGROUND OF THE lNvkNllON
Field of the Invention
The present invention relates to a dietary supplement,
and more particularly, to a dietary supplement for
alleviating the symptoms associated with enlargement of the
prostate gland.
Description of the Related Art
It is well known that many disorders are the result of
dietary deficiencies wherein the body is starved of certain
vitamins, minerals and other natural elements. Other
disorders are simply the result of aging. Disorders due to
aging may result if the body produces too much or too little
of certain enzymes or hormones, thereby affecting the body's
metabolism. Some disorders can be treated or corrected by
supplementing missing natural elements which are ordinarily
not found in the average diet. Through the use of a daily
supplement, supplying these missing vitamins and natural
elements, the symptoms of various disorders may improve or
disappear entirely.
In men, the prostate gland is the source of several
common disorders including prostatitis and benign prostatic
hypertrophy, wherein the prostrate gland becomes inflamed or
enlarged. Benign prostatic hypertrophy (BPH) occurs
naturally in most males over 50 years of age. At this age,
the male body begins to transform testosterone (male sex
hormone) into dihydroxytestosterone (DHT), at higher levels,
within the prostate. This is primarily due to higher levels
of the enzyme reductase which causes the conversion of
testosterone to DHT. DHT has a tendency to bind to
prostatic receptor cells which ultimately results in
prostate enlargement. It is usually a benign condition and,
21 74608
thus, in some cases there is no need for surgery. However,
enlargement of the prostate gland can cause many
uncomfortable and annoying symptoms including:
difficulty in starting to urinate;
increased urge to urinate;
a weak or interrupted stream when urinating;
a feeling that you cannot empty your bladder
completely;
a feeling of delay when you start to urinate;
a need to urinate often, especially at night; and
frequent or continuous lower back pain.
Nearly 400,000 prostate surgical procedures are
performed annually to treat enlarge prostates. Numerous
laboratories are conducting research in an attempt to find a
cure for BPH (benign prostatic hypertrophy). In 1992,
several new drugs were introduced to the market which
resulted in reductions of approximately 60%-70% of nicturia,
50% in diuria frequency, and 40% in post mictional residue.
However, some doctors have reported that as many as 15% of
patients have complained of impotency after taking these
drugs. Additionally, there are side effects which are noted
by the FDA, as reported in the January, 1995 issue of U.S.
News and World Report.
There are natural elements which have known benefits in
treating enlargement of the prostate gland and prostatitis.
Specifically, it is widely accepted in the field of medicine
that zinc has positive effects in reducing an enlarged
prostate (see "What Every Man Should Know About His
Prostate,~ Monroe E. Greenberger, M.D. and Mary Ellen Siegel
MSW, pages 96-105). However, studies have indicated that
when zinc is administered orally, it is difficult to reach
the prostatic tissue. Therefore, the prostate does not reap
the full benefits of the zinc.
Other studies have shown that pygeum africanum extract
has definite effects in reducing the size of the prostate
(Please refer to Medical Treatment of Benign Prostatic
Hypertrophy With the Pygeum Africanum Extract, n R.M. Scarpa,
21~4~Q~
R. Migliari, G. Campus, A. DeLisa, M. Sorgia, M. Usai, E.
Usai, Urology Clinic of the University of Cagliari).
Further, extensive studies carried out in Europe have
established that saw palmetto (serenoa repens) effectively
reduces the size of the enlarged prostate and restores
function. The saw palmetto berry contains an oil composed
of sterols and various saturated and unsaturated fatty
acids. In Europe, and now in the United States, the
purified fat soluble extract from the saw palmetto berry is
used medicinally.
Another natural product known to have beneficial
effects on the enlarged prostate is pumpkin seeds. While
there are no significant medical studies, pumpkin seeds have
been used as a folk remedy for centuries. In fact, it is
believed that Hungarian gypsies, Ukrainians and
Transylvanian's do not suffer from BPH because these
cultures eat pumpkin seeds from childhood as part of their
daily diet.
Presently, in the United States, most patients
suffering from benign prostatic hypertrophy and prostatitis
are treated with drugs such as Hytrin~ (Terazosin-HCI),
manufactured by Abbott Laboratories, Proscar~, manufactured
by Merck and Company, Inc., and Flutamide0. While these
drugs have beneficial effects in treating BPH, they have
known side effects, including impotency in men. More
specifically, Proscar~ is known to be transmitted to females
through semen during sexual intercourse, presenting a
significant health risk to women who are or could become
pregnant. Further, the FDA has reported that Hytrin~ may
cause Prioprism, resulting in persistent, painful erections
which can permanently damage the penis. The side effects of
Flutamide~ include painful swelling of the man's breasts as
well as nausea, vomiting and diarrhea.
Summary of the Invention
The present invention is directed to a dietary
supplement for alleviating the symptoms associated with
21 74608
enlargement of the prostate gland and inflammation of the
prostate gland and comprising pumpkin seeds, zinc glycinate,
extract of serenoa repens, pygeum africanum, magnesium and
Vitamin E acetate. While some of these elements have known
benefits to the prostate gland, as stated above, it has been
found that when combined in accordance with determined
proportionate ranges, the combined ingredients have
synergistic effects on reduction of the size of the prostate
gland, thereby providing more immediate and dramatic relief
to those suffering from the symptoms associated with BPH and
prostatitis, without the adverse side effects as experienced
with the above-mentioned drugs. The efficacy of the
composition was determined by monitoring various parameters
including serum prostate-specific antigen (PSA)
concentrations of patients over 90 day periods, nicturia,
diuria, and urine flow rate. These results were compared to
known results in past studies using only one element, or a
sub-combination of elements of the composition.
The fundamental elements of the composition of the
present invention include 400 to 800 mg of pumpkin seeds,
100 to 200 mg of zinc glycinate, 60 to 600 mg extract of
serenoa repens (saw palmetto extract), 200 to 400 mg of
pygeum africanum, 100 to 300 mg magnesium, and 300 to 600
I.U. Vitamin E acetate.
In accordance with the composition of the present
invention, it is a primary object to provide a dietary
supplement having beneficial effects in treating prostate
gland disorders.
It is a further object of the present invention to
provide a dietary supplement comprised of natural
ingredients including pumpkin seeds, zinc glycinate, extract
of serenoa repens, pygeum africanum, magnesium and Vitamin E
acetate, which, in combination, yield synergistic effects in
treating the symptoms associated with BPH and prostatitis.
It is still a further object of the present invention
to provide a dietary supplement comprised of all natural
ingredients for treating the symptoms associated with BPH
21 7460~
and prostatitis and which has no adverse side effects.
The fundamental elements of the composition include
pumpkin seeds in an amount of between 12.5% to 25% by weight
of the composition, extract of serenoa repens (saw palmetto
extract) in an amount of between 1.875% to 18.75% by weight
of the composition and pygeum africanum in an amount of
between 6.25% to 12.55% by weight of the composition. The
composition further includes zinc glycinate in an amount of
between 3.125% to 6.25% by weight, magnesium in an amount of
between 3.125% to 9.375% by weight, and Vitamin E acetate in
an amount of between 9.375% to 18.75% by weight of the
composition.
The composition preferably includes 25% to 35% by
weight Di-Tab, 0.8% to 1.2% by weight Syloid and 0.8% to
1.2% by weight magnesium stearate as excipients.
The composition is preferably provided in the form of
tablets or capsules. To do this, the ingredients are first
weighed in order to obtain the desired percentage by weight
of each of the ingredients to be mixed. Both serenoa repens
and pygeum africanum are readily available in liquid or
powder form. Liquid is preferred for use in capsules where
powder is used for tablets. The ingredients are homogenized
directly or in the presence of water by placing the
ingredients in a ribbon blender, wherein the ingredients are
mixed at medium to high speeds for 20 minutes at a
temperature of between 70 to 80 degrees Fahrenheit. The
mixture is then placed in dies in a compression machine to
mold the mixture into tablets. The compression machine
generates a compression of 7 tons, sufficiently compacting
the mixture into a uniform, integral tablet. After
compression, the tablets are coated with a fine coat of
pharmaceutical glaze in order to eliminate dust, prevent the
tablets from breaking apart and enhance their appearance.
The coated tablets are then placed in bottles (preferably 60
tablets to a bottle) and labeled for shipping and
distribution.
21 74608
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EXAMPLES OF THE COMPOSITION
Example 1 W%
Pumpkin seeds 18.75
Zinc glycinate 3.125
Magnesium 6.25
Vitamin E acetate 9.375
Extract of serenoa repens 15.625
(saw palmetto extract)
Pygeum africanum 9.375
Excipients, including:
Di-Tab
Syloid
Magnesium stearate 37.5
The recommended dosage for the average adult male is 6
tablets a day which will provide the following amounts of
each of the active ingredients of example 1:
Pumpkin seeds - 600 mg
Zinc glycinate 100 mg
Magnesium 200 mg
Vitamin E 300 IU
Saw palmetto extract 500 mg
Pygeum africanum 300 mg
Example 2 W%
Pumpkin seeds 12.5
Zinc glycinate 6.25
Magnesium 3.125
Vitamin E acetate 18.75
Saw palmetto extract 18.75
Pygeum africanum 6.25
Excipients, including:
Di-Tab
Syloid
Magnesium stearate 34.375
Example 3 W%
Pumpkin seeds 25.0
Saw palmetto extract 1.875
Pygeum africanum 12.5
Zinc glycinate 6.25
Excipients 45.625
Each of the three examples of the composition were
tested with patients suffering from BPH. The efficacy of
each of the three examples was determined by measuring
21 746(~8
various parameters includinq prostate-specific antigen
concentration (PSA), nicturia, diuria, and maximum urinary
flow rate. The results of each of these parameters were
compared with known results in the identical parameters for
patients treated with individual elements or sub-
combinations of the elements of the composition. The
overall results ranged between 5 to 8 times greater efficacy
of the above three examples compared to the known results of
studies using the individual elements of sub-combinations.
The determined efficacy of the composition of the above
examples reveals that there is a synergistic effect when
combining the elements of the composition within the
established range of proportions.
While the composition of the present invention has been
set forth in what is believed to be preferred embodiments,
it is recognized that departures may be made within the
spirit and scope of the following claims which, therefore,
should not be limited except within the doctrine of
equivalents.
Now that the invention has been described,
