All about - NANO-LEO

Transcription

All about
yyoo nn dd JJ uu ss tt EErr e c
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Contents
1.
2.
3.
4.
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6.
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13.
14.
15.
Prologue
Conventional Pharmacological Management - Limitations
Conventional Pharmacological Management - Concerns
NANO-LEO composition
Mechanism of action
Tribulus terrestris
-Pharmacology
-Hormone improvement
-Antioxidant potential
-Lipid profile
-Antihypertensive effect
-The evidence based phytoandrogen
Mucuna pruriens
-Pharmacology
-Neurotransmitter improvement
-Hormone improvement
-Antioxidant activity
-Serum cortisol improvement
-The evidence based Phytoandrogen
L-Arginine
Ginkgo biloba
Zinc & Testosterone
Yohimbe bark extract
LEON clinical study - Summary
LEON clinical study - Observations
NANO - LEO Credentials
Safety profile
3
4
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5
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12
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45
49
2
Prologue
S
ex is perceived to be an act of reproduction and recreation. Sexual function of
a man is complex and has numerous aspects to influence.
Lifestyle imbalances, stress and various other aspects affect sexual function.
Traditionally various foods and natural elements were used to address all these aspects
so as to improve sexual health and overall quality of life. The conventional
pharmacological approaches to treat sexual dysfunction exhibit limitation as they
address any single parameter and not the comprehensive coverage such as
Testosterone formulations for hormone deficiency, PDE5 inhibitors for vascular
problem, Antidepressants for psychological problems.
An unmet need existed to have an option that addresses all three parameters, thus led
®
®
to development of NANO-LEO . NANO-LEO is the synergistic nutritional
supplement that may probably be the only one to have undergone toxicity study and
clinical study.
Conventional Pharmacological Management - Limitations
PDE-5 Inhibitors
Works only in men with adequate testosterone; Drug-Drug & Drug-Food interactions
Vacuum Constriction Devices
Unnatural erections, Causes numbness, Trapped ejaculation
Alprostadil
Invasive, Priapism, Penile fibrosis
Penile prosthesis
Prone to infection
Testosterone (Orals & Injectable)
Can't be used over long period
Psychosexual therapy
Patient resistance, variable efficacy
Alternative medicine
Evidence based ???, Nephrotoxicity, Hepatotoxic, Toxicity to eye
Conventional Pharmacological management - Concerns
Sildenafil Citrate
Drug Interactions, Oedema, Photosensitivity Reactions,
Prolonged Erections, Tachycardia, Thickness in Chest,
Nausea & Vomiting, Skin Rashes, Sudden Decrease in Hearing,
Ear Pain, Nocturia, Tinnitus, Increase in Urinary Frequency
Malaise, Sweating, Fainting.
Testosterone (HRT)
Prolonged Usage Results in Serious Hepatic Adverse Effects,
Geriatric Patients at Increased Risk of Prostatitis,
Oedema without CHF, Alopecia, Gynaecomastia,
Reduction in Spermatogenesis,
Drug Interactions With Insulin, Corticosteroids,
Nausea & Vomiting, Aggression.
4
NANO-LEO has been licensed by
Food Safety and Standards Authority of India as nutritional product. Hence it
can be safely recommended by Health care professionals of any discipline.
Composition
Prosexual Nutrient
L-Arginine
500 mg
Tribulus terrestris
200 mg
Mucuna pruriens
20 mg
Ginkgo biloba
20 mg
Zinc
10 mg
Yohimbe bark
1 mg
Ingredient
Active component
Category
Tribulus terrestris
Protodioscin
Steroidal Saponin
Mucuna pruriens
L-DOPA
Precursor of
Neurotransmitter Dopamine
Ginkgo biloba
Ginkgolides
Lactone Derivatives
Yohimbe bark extract
Yohimbine
Indole Alkaloids
L-Arginine
Nitric oxide
Essential Aminoacid
Zinc
Essential Mineral
2 capsules at bed time for first 7 days and
later 1 capsule at bed time till 90th day.
The Comprehensive Support for
L ibido, E rection, O rgasm
6
Mechanism of Action
do
Libi
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Org
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Hor monal
an
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Neurot
r
No
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ine
Pr
o
tin
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Testosterone
Dopamine
ep
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Y
im
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uriens
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®
NANO-LEO is a synergistic combination of Phytoandrogens, L-Arginine and neurotransmitter boosting
nutritionals that support Libido, Erection and Orgasm.
Libido
®
Globally popular, evidence based phytoandrogens in NANO-LEO such as Tribulus terrestris and Mucuna
pruriens improve libido by improving testosterone, DHEA and neurotransmitters. Hormones like
testosterone and DHEA are deprived in diabetic men, hence support with NANO-LEO® boosts libido in
diabetics. Likewise, there is a compromise of erectile function consequent to poor libido and elevated
prolactin levels due to antidepressants (Tricyclics, MAO-I, SSRI). Mucuna pruriens being a rich source of
L-DOPA promotes dopamine, also brings down the prolactin levels naturally correcting the dysfunction.
Zinc improves bioavailability of testosterone .
Erection
Erectile dysfunction may be due to poor circulation problems, due to inappropriate hormone profile or due to
microvascular complication consequent to diabetes. Nitric oxide donors such as L-Arginine and nitric oxide
boosters such as Protodioscin rich extract of Tribulus terrestris improve Nitric oxide, thereby improving
®
erectile function. NANO-LEO is also powered with Ginkgo biloba extract, which exhibits an excellent
vasodilatory ability thereby improving the erectile function. Apart from vasodilation, it is important to have
physiological testosterone levels to achieve proper erection. Even phosphodiesterase-5 (PDE-5) inhibitors
®
fail due to inadequate testosterone levels. Phytoandrogens in NANO-LEO ensure boosting of testosterone
naturally, helping a physiological erection.
Orgasm
Yohimbe bark extract offers Yohimbine as pharmacological component that corrects orgasmic dysfunction.
8
Tribulus terrestris
T
Tribulus terrestris - Pharmacology
Protodioscin from fruit extract of Tribulus
terrestris, stimulates Testosterone conversion to
DHT which improves Erythropoiesis and overall
health. Apart from testosterone stimulation,
Protodioscin is responsible to improve DHEA
which facilitates physiological early morning
erection.
Additional Uses
Tribulus by virtue of its NO relaxing effect is useful in
angina pectoris. It was demonstrated in 406 cases of
angina that Protodioscin mediated Nitric Oxide is useful
to dilate arteries and increase blood flow through
coronary blood vessels of heart.
Safety
At recommended doses, Tribulus is safe herb. No
adverse events noted in any of clinical trials or human
research studies. LD50 in rats is greater than 10g per kg of
body weight. Based on animal data ( as per acute and long
term studies ) it is estimated that a human would have to
consume 100 times the average recommended dose of
750 mg. A daily dose of upto 1500 mg has been used
safely.
PROTODIOSCIN
Testosterone
Dihydrotestosterone
Erythropoiesis + Muscle
Development
OH
OH
HO
HO
O
O
O
HO
O
H
O
O
HO
O
O
H
H
OH
O
HO
HO
Increase in
Hemoglobin Level
OH
OH
HO
OH
Protodioscin
Structural component
Homologous to testosterone nucleus
Traditional Use
Traditionally used by ancient greeks as general tonic and
across the world to promote sexual health.
Increase in
Oxygen Transport
Increase in Sexual Functions
10
Tribulus terrestris - Hormone Improvement
86%
Increase in
DHEA-S in
Non-Diabetic
ED patients
with Tribulus
DHEA-S in Non-Diabetics
55%
Increase
in DHEA-S
in Diabetic
ED Patients
59%
Decrease
In ED patients
Compared to
Non-ED
patients
DHEA-S in Diabetics
58%
Decrease
In ED patients
Compared to
Non-ED
Diabetics
Int. J. Impotence Res.Vol. 9, supp 1 (1997)
Tribulus terrestris - Antioxidant Potential
Tribulus - Antioxidant Potential
Parameters
Pre-Treatment
Post-Treatment
Leukocytes (106/mL)
9.06 + 5.27
6.67 + 2.40
-amylase (mg/mL)
25.69 + 7.62
58.04 + 8.99
Increase by
126%
Leukocyte Count
Decrease by
26%
Improvement in
 -amylase enhances
acrosome reaction
-amylase
By decreasing Leukocytes,
it decreases oxidative stress generated
Nikolova, V. & Stanislavov, R.;Comptes Rendus de l'Academie Bulgare des Sciencesi, vol. 53,; 2000: p.12:113
12
Tribulus terrestris - Lipid Profile
Tribulus - Lipid Profile
Pre-Treatment
Pre-Treatment
Cholesterol (mmol/L)
5.99 + 1.05
4.97 + 0.87
HDL (mmol/L)
0.96 + 0.22
1.18 + 0.22
LDL (mmol/L)
3.41 + 0.60
2.29 + 0.45
VLDL (mmol/L)
0.58 + 0.15
0.28 + 0.14
Triglyceride (mmol/L)
1.62 + 0.50
0.99 + 0.38
Parameters
23%
Increase
TOTAL
CHOLESTEROL
LDL
VLDL
TRIGLYCERIDE
17%
52%
33%
39%
Decrease
Decrease
Decrease
Decrease
HDL
Tribulus terrestris has a favorable effect on lipid profile, by a 23% improvement
of HDL levels. Also an improvement of total cholesterol (17%), LDL (52%),
VLDL (33%), Triglyceride profile (39%)
Nikolova, V. & Stanislavov, R.;Comptes Rendus de l'Academie Bulgare des Sciencesi, vol. 53,; 2000: p.12:113
Tribulus terrestris - Antihypertensive Effect
%
4
7.
8 9%
%
%
6
9.
~91
1%%
%
5
8.
9
%
Group A
Group B
Mean B.P.
Systolic B.P.
Diastolic B.P.
Usage of Tribulus terrestris over a period results in improvement of Mean Blood
pressure, Systolic Blood pressure and Diastolic blood pressure. Rendering Tribulus
terrestris Safe in mild to moderate hypertensives.
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Tribulus terrestris - The Evidence Based Phytoandrogen
Level of
Evidence
A
B
Effect
Testosterone
Erections
Scientific
Consensus
66 %
Comments
In otherwise healthy males, testosterone is not influenced with
supplementation of Tribulus terrestris. There may be an increase in
infertile men but this is weak.
100 %
In infertile men, supplementation of 6g Tribulus root appears to
increase rigidity of erections and improve performance (reduce
anxiety while delaying ejaculation and improving... show orgasm).
B
Libido
100 %
There appears to be an increase in frequency of coitus and
improvement in sexual well being associated with supplementation of
6g of the basic root extract of Tribulus.
B
Sperm Quality
100 %
The increase in sperm count seen with Tribulus failed to outperform
placebo
B
Sperm Count
100 %
The increase in sperm quality seen with 6g Tribulus root has failed to
outperform placebo in infertile men.
B
Lean Mass
100 %
Insufficient evidence to support an increase of lean mass associated
with tribulus relative to placebo during a training program.
B
Fat Mass
100 %
No significant influences on fat mass are noted with Tribulus terrestris
B
Power Output
100 %
No significant alterations in power output associated with Tribulus
supplementation.
B
Luteinizing
Hormone
100 %
No influence on luteinizing hormone has been detected with
supplemental Tribulus.
Level of
Evidence
A
Effect
Scientific
Consensus
Comments
B
Fatigue
50 %
Exercise related fatigue and vigor is unaffected by tribulus
supplementation in trained men.
B
Blood Pressure
100 %
A decrease in blood pressure has been noted in hypertensive subjects;
insufficient evidence to address efficacy in normotensive persons
B
Heart Rate
100 %
A decrease in heart rate has been observed in hypertensive persons
given Tribulus supplement
B
Total Cholesterol
100 %
A decrease in cholesterol levels has been noted with tribulus
supplementation
B
Diuresis
100 %
3g of the fruits or a water extract thereof appears to increase overall
urine volume after a month of supplementation by around 200 ml
daily.
Multiple studies where at least two are
double-blind and placebo controlled.
B
Single double blind study or multiple
cohort studies.
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Mucuna pruriens
M
Mucuna pruriens - Pharmacology
NH 2
CH 2 C COOH
HO
OH
Mucuna pruriens
The Phytoandrogen
H
Chemical structure of
L-3,4-dihydroxyphenylalanine (L-DOPA)
Part used & Active component
L-Dopa from Mucuna pruriens is a precursor of
neurotransmitter dopamine, that facilitates to
improve libido and arousal in a man.
Safety
Apart from mild gastro intestinal complaints no major
adverse events were reported on usage.
L-DOPA
Stimulates
Hypothalamus
GnRH
Gonadotrophins
Anterior pituitary
Sexual
Performance
Testosterone
Lipid
peroxidation
LH FSH
Testis
Traditional Use
Traditionally been used as Dopamine booster especially in
treating Parkinson disease.
Additional Uses
Mucuna pruriens has ability to decrease prolactin
secretion
Seminiferous tubule
Sertoli cells
Leydig cells
-Fertil Steril 2008.
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Mucuna pruriens - Neurotransmitter Improvement
Group B
Group A
Group C
Dopamine
%
44
%
44
%
47
%
58
%
64
%
75
%
73
%
71
65
%
Adrenaline
Noradrenaline
Treatment with Mucuna pruriens recovered the seminal plasma and blood plasma levels of
Dopamine, Adrenaline and Noradrenaline
IMPROVEMENT
Group A
Group B
Group C
DOPAMINE
65%
71%
73%
ADRENALINE
75%
64%
58%
NORADRENALINE
47%
44%
44%
Neurotransmitter
Mucuna pruriens - Hormone Improvement
Group B
%
%
40
38
%
%
11
LH(mIU/mL)
T(ng/mL)
PRL(ng/mL)
%
Fertil Steril. 2009 Dec;92(6):1934-40
32
41
%
19
Group C
39
%
%
27
23
%
Group A
Sperm concentration and motility in infertile men were statistically significantly less as compared with controls. The sperm concentration in oligozoospermic and sperm
motility in asthenozoospermic group were significantly less as compared with controls. Treatment with Mucuna pruriens for three months showed significant reversal
of above parameters with an improvement in sperm concentration by 57.6% and improvement in motility by 41%.
Hormonal parameters of patients before and after treatment with M.pruriens.
Hormonal
parameters
Group A
Group B
Posttreatment
Control
Pretreatment
Posttreatment
LH (mIU/mL)
7.35 + 0.52
6.08 + 0.93a (-17)
7.50 + 0.96 b (+23)
5.15 + 0.97c (- 30)
FSH (mIU/mL)
6.22 + 1.71
7.11 + 1.30a (+14)
6.28 + 1.94b (-11)
T (ng/mL)
5.63 + 0.81
4.49 + 0.53a (-20)
PRL (ng/mL)
6.68 + 2.03
6.75 + 1.13a (+1)
Group C
Pretreatment
Posttreatment
7.28 + 0.92b (+41)
4.14 + 1.35c (- 43)
5.79 + 0.97b (+40)
8.30 +1.06c (+33%)
6.32 + 1.46b (-24)
7.28 + 2.05c (+17)
6.67 + 1.29b (-8)
5.72 + 0.36b (+27)
3.89 + 0.95c (-30)
5.40 + 0.48b (+39) )
2.65 + 0.73c (-52)
3.66 + 0.39b (+17)
5.45 + 0.66b (-19)
10.76 + 2.94c (+61)
7.28 + 1.66b (-32)
6.92 + 1.53c (+4)
6.16 + 1.74b (-11)
Pretreatment
Note: Results are expressed as mean SD values in parentheses indicate percentage change (pretreatment groups vs. control and posttreatment groups vs. respective pretreatment groups).
a P<.05 vs. control group.
b P<.01 vs. pretreatment group.
c P<.01 vs. control group.<.05 vs. control group.
LH = Luteinizing hormone
FSH = Follicle Stimulating Hormone
T = Testosterone
PRL = Prolactin
Group A=Normozoospermic men
Group B=Asthenozoospermic men
Group C=Oligozoospermic men
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Mucuna pruriens - Antioxidant Activity
Group B
18
20
11
%
50
%
26
%
7
Ascorbic acid
Glutathione
-2
%
7
Super oxide Dismutase
Catalase
Lipid peroxide
-2
-3
2
%
4.
5
%
%
19
%
%
%
33
%
18
%
15
%
8
%
3
%
Group C
Group A
Treatment with Mucuna pruriens has significant reversal of the levels of lipid peroxides in infertile men.
Treatment with Mucuna has enhanced the activity of all three innate antioxidants - Superoxide Dismutase,
Catalase and Ascorbic acid which were otherwise found to be significantly suppressed in infertile men.
Glutathione Stimulating hormone levels have also been restored after treatment.
Biochemical parameter
Group A
Group B
Group C
-32.4%
-27.3%
-27.3%
Super oxide dismutase
3.1%
33.3%
19.3%
Catalase
8.1%
4.5%
10.8%
Ascorbic Acid
15.0%
26.1%
20.0%
Glutathione
18.0%
50.0 %
18.0%
Lipid peroxide
Mucuna pruriens - Serum Cortisol Improvement
60 %
55%
49.4%
Serum cortisol
IMPROVEMENT
51.6%
45.1%
40 %
40.6%
Group A
20 %
Group B
17.7%
@ 0800 HRS
Group C
@ 1600 HRS
Stress scores, elaborated on the basis of the questionnaire, were found significantly high in infertile, marked
by the elevation of the morning serum cortisol levels. The cortisol levels and the stress scores are
improved after treatment with Mucuna pruriens.
IMPROVEMENT @ 0800 HRS
IMPROVEMENT @ 1600 HRS
Group A
17.7%
40.6%
Group B
51.6%
45.1%
Group C
55.0%
49.4%
Serum Cortisol
22
Mucuna pruriens - The Evidence Based Phytoandrogen
Level of
Evidence
Effect
Change
Scientific
Consensus
Comments
There appears to be an increase in seminal quality and oxidative parameters
following three month of ingestion of M.pruriens, which is thought to be secondary
to correcting HPA
A
Sperm
Quality
100 %
I. Shukla KK et al.; M. pruriens improves male fertility by its action on
Hypothalamus - pituitary - gonadal axis: Fertil steril 2009 dec(6)1934-40
2. Shukla KK et al.; M.pruriens reduces and improves the quality of semen in fertile men: Evid Based
Complement Alternat Med 2010 mar;7(1):137-44
3.Gupta A et al. A proton NMR study of the effect of Mucuna pruriens on seminal plasma
metabolites of infertile males : J Pharm Biomed Anal. 2011 Jul 15; 55(5):1060-6.
An increase in testosterone is seen in infertile men. It is unsure if this increase in
Testosterone occurs in fertile and other healthy men .
B
Testosterone 100 %
1.Shukla KK et al.; Mucuna pruriens improves male fertility by its action on the hypothalamuspituitary-gonadal axis: Fertil steril 2009 dec(6) 1934-40
2.Shukla KK et al.; M.pruriens reduces and improves the quality of semen in fertile men: Evid Based
100 %
1.Shukla KK et al.; Mucuna pruriens improves male fertility by its action on the hypothalamuspituitary-gonadal axis: Fertil steril 2009 dec(6) 1934-40
A decrease in Prolactin appears to occur following Mucuna or L-DOPA ingestion.
B
B
Prolactin
Nor
100 %
Adrenaline
The reduction in noradrenaline levels seen in infertility is normalized following
mucuna ingestion.
1 . S h u k l a K K e t a l . ; M u c u n a p r u r i e n s i m p r ove s m a l e f e r t i l i t y by i t s a c t i o n o n
the hypothalamus-pituitary-gonadal axis: Fertil steril 2009 dec (6) 1934-40 2.
Level of
Evidence
B
Effect
Change
Dopamine 100 %
Scientific
Consensus
Comments
The reduction in dopamine seen in infertility is reversed with L-DOPA
ingestion theoretically
1.Shukla KK et al .; Mucuna pruriens improves male fertility by its action on the hypothalamus-pituitary gonadal axis: Fertil steril 2009 dec (6) 1934-40 2.
The decrease in adrenaline seen in infertility is normalized with Mucuna
B
Adrenaline 100 %
1. shukla KK et al .; Mucuna pruriens improves male fertility by its action on the hypothalamuspituitary-gonadal axis: Fertil steril 2009 dec (6) 1934-40 2.
An increase in seminal motility is observed following Mucuna ingestion
B
Seminal
Motility
100 %
Complement Alternat Med 2010 mar ;7(1):137-44
In chronically stressed men, prolonged ingestion of Mucuna pruriens appears to be
able to reduce cortisol concentrations
B
Cortisol
100 %
Complement Alternat Med 2010 mar ;7(1) : 137-44
24
L-Arginine
L
L-Arginine
H
N
NH
NH2
H
OH
H 2N
O
L-Arginine is a conditionally essential amino acid.
L-Arginine plays a role in the formation of important
physiologic factors including nitric oxide (NO, a
vasodilator).
Safety
L-arginine is safe for most people when taken
appropriately by mouth. Unless in very high doses,
where it can cause some side effects such as abdominal
pain, bloating, diarrhea, sudden decrease in blood
pressure and it is considered safe.
Clinical trials showed that L-Arginine
supplementation enhances endotheliumdependant vasodilation by increasing nitric oxide
(NO) production in these patients, who have lower
levels of NO.
Additional Uses
Increasing NO production through L-Arginine
supplementation might therefore be beneficial by
restoring vasodilation and improving muscular
metabolism in patients with cardiovascular disorders,
Angina pectoris and Intermittent claudication.
Main use
26
Ginkgo biloba
G
Ginkgo biloba
O
O
O
H
H
H
H
O
H 3C
OH
O
H
O
O
OH
O
O
O
H
O
H
H
O
O
H
t-Bu
OH
O
Geographical presence
China, Japan, Vietnam
The dried green leaves from the Ginkgo tree. Ginkgo
biloba leaf extract contains Terpenoids ( Ginkgolides
and Bilobalides ) and Flavonoids.
Safety
Ginkgo Biloba is relatively safe. There has been
very few reported cases of adverse effects, which
included stomach complaints, dyspepsia, and nausea
Traditional Use
Improves memory, erectile function.
Useful in treating Impaired mental performance,
Raynaud's syndrome, Erectile Dysfunction, Tinnitus &
Vertigo.
Ginkgo biloba
Nitric Oxide
Penile Microcirculation
Erectile function
Additional Uses
28
Zinc & Testosterone
Z
Zinc & Testosterone
O
Androstenedione
17--hydroxylase
Zn
O
O
Cyclic Aromatase
NADPH
A
Estrone
HO
Zn
OH
Zn
OH
Zn
A
O
Testosterone
Researchers showed that with increased zinc intake,
testosterone levels in the elderly population almost
doubled. This is a powerful evidence that zinc has
an impact on testosterone production.
Sense of smell may actually be important to libido,
especially in younger men. Zinc deficiency, reduce sense
of smell, and also reduce libido. Zinc deficiency not
only impacts the level of testosterone, but may
cause a loss of the ability to detect subtle
chemicals that induce arousal.
17-Estradlol
HO
The effect on onset of sexual function was strikingly
enhanced in those receiving zinc capsules as a
supplement.
(The American Journal of Medicine Volume 53, Issue 3, September 1972, Pages 277-284).
Improves testosterone concentration
Zinc
Accelerates onset of sexual function
Improves sexual potency
Human Reproduction Update, Vol.13, No.2 pp. 163-174, 2007
30
Yohimbe Bark Extract
Y
N
N
H H
O
O
H
OH
Bark extract and the active component is Yohimbine.
About Yohimbine
Yohimbine is effective for impotence, especially of
vascular, diabetic, or psychogenic origins. It can
improve the quality and duration of erections, usually
without increasing sexual excitement. A systematic
review and meta-analysis of seven randomized clinical
trials ( that fit the predefined inclusion criteria ) was
conducted to evaluate therapeutic efficacy and safety of
yohimbine in treating erectile dysfunction.
The meta-analysis demonstrated that yohimbine is
effective in treating erectile dysfunction. Lower doses
of yohimbine, given to patients who are fasting or eating
a low-fat diet, may be more effective
(Grasing et al., 1996; J Clin Pharmacol 36(9):814822)
Traditional Use
In Central Africa & the United States, yohimbe bark
is widely used in numerous dietary supplements
that claim to be aphrodisiac, athletic performance
improvers (as an alternative to anabolic steroids)
and male sexual performance enhancers. The most
commonly prescribed drug for functional impotence is
yohimbine hydrochloride.
Additional Uses
The Merck Index reports its therapeutic category as an adrenergic blocker and mydriatic (causing pupillary
dilatation). Its use is reported as a pharmacological
probe for the study of 2-adrenoceptor.
(Ernst and Pittler, 1998; J Urol 159(2):433436).
32
LEON Study
An exclusive clinical study with
NANO-LEO®
L
LEON Clinical Study - Summary
Clinical efficacy and safety study for the evaluation of libido, erection &
orgasm with a pro-sexual nutrient : A 12 -week, single centric. Single-blind study.
Dr.S.N.Shankhwar1, Dr.A.A.Mahdi1, Dr.A.V.Sharma2, Dr.D.M.Ravichand3
1
Professor & Head, Department of Urology, 1Professor & Head -Department of Biochemistry,
Chhatrapati Shauji Maharaj Medical University, Uttar Pradesh ,Lucknow- 2260003,
2
Head- Regulatory Affairs and R & D, Sanzyme Ltd, Plot No 13, Sagar Society,
Road No 2, Banjara Hills, Hyderabad 500034, [email protected] ,
3
Associate Professor, Department of Pharmacology, Karpagam Faculty of medical sciences & Research,
Othakkalmandapam, Coimbatore.
Abstract:
Objective
To evaluate the efficacy of pro-sexual nutrient consisting of phyto pharmaceutical ingredients along with an amino
acid & trace element in improving libido, erection, orgasm. The primary objective of the study is to assess the safety and
®
efficacy of the pro-sexual nutrient NANO-LEO .
Introduction
The therapeutic efficacy measure available for erectile dysfunction includes sex therapy and psychological therapy.
Pharmacological drug induced erections have found to have limitations, side effects and complications. There is a need
for an effective and non invasive method for treatment of sexual dysfunction. The present investigation is a singleblind, safety and efficacy study with pro-sexual nutrient NANO-LEO® for the evaluation of libido, erection & orgasm.
The study is aimed at to evaluate the efficacy of pro-sexual nutrient consisting of phytopharmaceutical agents along
with an amino acid & trace element as treatment in improving libido, erection, orgasm and the QOL (Quality Of Life).
Material &Methods
Patients either diagnosed with temporary problem in libido, erection & orgasm, eligibility criteria disorders, or
performance anxieties were chosen for the study with a sample size of 100. One soft gelatin capsule with a loading dose
- Data on file
34
of 2 capsules for 7 days initially and thereafter one soft gelatin capsule was given at bed time for a period for the
remaining period of the study of the 90 days. The overall improvements of sexual parameters were assessed along with
the biochemical parameters as per the study protocol.
Results and discussion
The total number of patients enrolled in the study was 99 with mean (SD) age of 32.2 years(4.71). According to
Friedman test the results showed that overall there was significant improvement sexual parameters such as erectile
function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction (p<0.0001). The results were
compared with paired T test and found that there were no significant changes in the laboratory parameters. Overall the
results were promising that and there was no significant difference between the visits in the vital sign measurements
when compared with that of the controls. The product NANO-LEO® aids in the improvement of sexual dysfunction
with no side effects.
Conclusion
Based on the study we conclude that there was significant improvement in libido, erection and orgasm as evaluated by
gathering personal information and also by questionnaires (international index of erectile function (IIEF), sexual health
®
inventory for men (SHIM) and quality of life (QOL)). Hence it can be concluded that the product NANO-LEO is a
breakthrough in the treatment of sexual dysfuntion, even in individuals with mild to moderate hypertension,
and diabetes mellitus. Adverse effects, especially changes in renal and hepatic function, are a major concern to
andrologists and urologists, however the safety demonstrated by NANO-LEO® makes it a viable option for treating
disorders of libido, erection and orgasm.
KEY WORDS
Erectile Dysfunction, Impotence, pro-sexual nutrient, Phyto pharmaceutical agent, Orgasm, Sexual disorders.
LEON Clinical Study - Observations
SD = Severe Dysfunction
MoD = Moderate Dysfunction
M-MoD = Mild to Moderate Dysfunction
MD = Mild Dysfunction
ND = NO Dysfunction
70
VISIT 1
VISIT 2
VISIT 3
VISIT 4
IIEF Scores in percenage
60
50
40
30
20
10
0
SD
MoD
M-MoD
MD
ND
Erectile Dysfunction
Observations-Baseline
Around ~5% of enrolled subjects suffer around severe dysfunction, ~10% suffering with Moderate dysfunction
~27% with mild to moderate dysfunction, ~42% with mild dysfunction and 16% of subjects have no problem with
erectile function.
Observations-after 90 days treatment
An improvement of severity of erectile dysfunction is observed in all the groups, with no patients in severe
dysfunction group ( 5% improvement ), 7% improvement in Moderate dysfunction group, 20% improvement
in Mild to moderate dysfunction group, 6% improvement in mild dysfunction group. Amongst the enrolled
subjects, those who have NO dysfunction have gone up from 16% to 54%.
- Data on file
36
ND = NO Dysfunction
70
VISIT 1
VISIT 2
VISIT 3
VISIT 4
60
50
40
30
20
10
0
SD
MoD
M-MoD
MD
ND
Sexual Desire
Around ~2% of enrolled subjects suffer around severe dysfunction, ~21% suffering with Moderate dysfunction,
sexual desire
An improvement of severity of sexual desire is observed in all the groups, with no patients in severe dysfunction
group ( 2% improvement ), 17% improvement in Moderate dysfunction group, 29% improvement in Mild to
moderate dysfunction group, 42% improvement in mild dysfunction group. There is an increase of 6% of
patients enrolled suffering from NO dysfunction.
- Data on file
ND = NO Dysfunction
70
VISIT 1
VISIT 2
VISIT 3
VISIT 4
60
50
40
30
20
10
0
SD
MoD
M-MoD
MD
ND
Orgasmic Function
Orgasmic function
An improvement of severity of orgasmic dysfunction is observed in all the groups, with no patients in severe
dysfunction group ( 4% improvement ), 7% improvement in Moderate dysfunction group, 23% improvement
in Mild to moderate dysfunction group. The increase in number of subjects in mild dysfunction group, can be
attributed to the shift of some of the patients in the other severity categories to mild dysfunction group. On the whole,
36% of patients enrolled had NO dysfunction at the end of study.
- Data on file
38
ND = NO Dysfunction
55
IIEF Scores in Percentage
50
45
40
VISIT 1
VISIT 2
VISIT 3
VISIT 4
35
30
25
20
15
10
5
SD
MoD
M-MoD
MD
ND
Intercourse Satisfaction
Intercourse satisfaction.
moderate dysfunction group. At the end of study, ~43% of patients experienced NO dysfunction with
respect to Intercourse satisfaction.
- Data on file
ND = NO Dysfunction
55
IIEF Scores in Percentage
50
45
40
VISIT 1
VISIT 2
VISIT 3
VISIT 4
35
30
25
20
15
10
5
SD
MoD
M-MoD
MD
ND
Overall Satisfaction
Approximately around 8% of enrolled subjects suffer around severe dysfunction, approx 21% suffering with Moderate
dysfunction, approx 16% with mild to moderate dysfunction, approx 26% with mild dysfunction and 28% of subjects
have no problem with Overall satisfaction.
moderate dysfunction group. At the end of study, approx 26% of patients experienced NO dysfunction with
respect to Overall satisfaction.
- Data on file
40
300
250
Values
200
VISIT-1
VISIT-4
T = Testosterone
FSH = Follicle Stimulating hormone
LH = Luteinizing hormone
PRL = Prolactin
150
100
50
0
T
FSH
LH
PRL
Laboratory Parameters
Hormone profile
10 ng/ml improvement in mean testosterone
Approximately no unfavorable change in LH and FSH levels
There is a slight decrease in Prolactin as well.
®
Overall, after 90 days of treatment with NANO-LEO ensures
favorable hormone profile ( which is critical to ensure male sexual function )
300
250
Values
200
VISIT-1
VISIT-4
LFT = Liver Function test
RFT = Renal Function test
SGOT = Serum Glutamic Oxaloacetic Transaminase
SGPT = Serum Glutamic Pyruvic Transaminase
Cr = Creatinine
BU = Blood Urea
150
100
50
0
SGOT
SGPT
LFT
BU
Cr
RFT
Laboratory Parameters
Safe on Liver
Approximately 10% improvement in mean LFT-SGOT levels and approximately 8% improvement in mean
LFT-SGPT levels after 90 days of NANO-LEO® treatment indicates that NANO-LEO® is Safe on liver.
Safe on Kidney
®
Approximately 52% improvement in mean creatinine levels indicates that NANO-LEO is Safe on kidney.
- Data on file
42
140
Measurement values
120
Visit-1
Visit-2
Visit-3
Visit-4
100
80
60
40
20
0
BMI
Heart Rate
WM
Temperature
Vital Signs
Vital Signs
No unfavorable changes seen in Body Mass Index (BMI), Waist Measurement (WM),
®
temperature and Heart rate after 90 days of treatment with NANO-LEO , proving it to be Safe
on Cardio-metabolic Vital signs
- Data on file
140
Measurement values
120
100
80
60
40
20
0
SBP
(Supine)
DBP
(Supine)
SBP
(Sitting)
DBP
(Sitting)
Vital Signs
Blood Pressure
After 90 days of treatment, no significant change is recorded in Systolic blood pressure (SBP) or
Diastolic blood pressure (DBP) -Supine or Sitting, implying that NANO-LEO® was Safe on all
those 99 patients not affecting Blood pressure adversely.
Disclaimer : No part of this (Data on file) can be published without prior permission of the author and sponsors of the study
- Data on file-
44
NANO-LEO Credentials
®
Tribulus terrestris
AMERICAN BOTANICAL COUNCIL
406 cases of angina pectoris in coronary heart disease treated with saponin of Tribulus
terrestris, which dilates the coronary artery.
HOMOEOPATHIC MATERIA MEDICA
An East Indian drug useful in urinary infections, especially dysuria, and in debilitated
states of the sexual organs, as expressed in seminal weakness, ready emissions and
impoverished semen, prostatitis, calculous infections and sexual neurasthenia. It meets
the auto-traumatism of masturbation correcting the emissions and spermatorrhoea.
WHO MONOGRAPHS ON SELECTED MEDICINAL PLANTS
In 80% of the patients, oral treatment for 60 days restored libido, erection, ejaculation
and orgasm of sexual intercourse. A significant increase in frequency of sexual
intercourse of 60% in subjects with or without diabetes and with or without ED.
NATURAL MEDICINES
COMPREHENSIVE DATABASE
Orally, Tribulus is used for enhancing athletic performance, male impotence, spermatorrhea, gonorrhea,
kidney stones, and painful urination. It is also used for angina pectoris, hypertension, hypercholesterolemia,
treating anemia, atopic dermatitis (eczema), psoriasis, rheumatism, leprosy, and scabies. It is used as
aphrodisiac, astringent, diuretic, tonic, mood enhancer and vermifuge.
46
Mucuna pruriens
Its use can be traced back to 4500 years. Interest in Mucuna pruriens has grown especially
amongst individuals searching for a natural treatment. Mucuna pruriens seeds, unlike other
natural substances are made up of more than just levodopa
Seeds are rich source of L-Dopa
NATURAL MEDICINES
Offically listed in
Ginkgo biloba
WHO monographs on
selected
medicinal
plants
Volume I
Globally used herb in Australia, south-east Asia, Europe, Japan, and the
United States of America.
World Health Organization
Geneva
AMERICAN BOTANICAL COUNCIL
THE COMPLETE GERMAN
COMMISSION E MONOGRAPHS
Over four hundred scientific studies conducted on proprietary standardized extracts of the
leaf of Ginkgo in the past 30 years. Ginkgo biloba extract (GBE) has been popular in
Europe, in the United States and in other parts of the world for its neuroprotective properties
and ability to aid circulatory problems in the elderly.
THERAPEUTIC GUIDE TO
HERBAL MEDICINES
of Herbal Exellence
INTEGRATIVMEDICINE
EUROPEAN MEDICINES AGENCY
S C I E N C E M E D I C I N E S H E A LT H
NATURAL MEDICINES
Reported to have well established use in
management of Nervous system disorders and
Immune system disorders
Ginkgo biloba is sometimes used to reverse the sexual
performance problems that can accompany taking certain
antidepressants called SSRIs.
Preparations obtained from the bark of Yohimbe have been traditionally used in West Africa as
general tonic, as a performance enhancer for athletes and as an aphrodisiac. Yohimbine, the main
alkaloid of Yohimbe bark, in its hydrochloride form, is the active ingredient of a number of
medicinal products authorised in several EU countries. It is given orally in the treatment of erectile
dysfunction in doses of 5-10 mg b.i.d to t.i.d and the typical treatment period being 8 weeks.
In the United States, Yohimbe bark is widely used in numerous aphrodisiac supplements, athletic
performance enhancing supplements and male sexual performance enhancing dietary
supplements. Yohimbe bark has been used in western Africa as aphrodisiac, especially in male
erectile disorders, reportedly stimulating both erection and salivation.
Medicinal use of Yohimbe bark has been in practice in Europe since 1890s.
The drug Yohimbine, derived from Yohimbe bark has been approved by the United States Food
and Drug Administration for prescription use only.
NATURAL MEDICINES
Orally, Yohimbe is used as an aphrodisiac for impotence, erectile dysfunction, athletic
performance, weight loss, exhaustion, angina, hypertension, diabetic neuropathy and
postural hypotension. Yohimbe is also used for general sexual dysfunction in men
and women caused by Selective Serotonin Re uptake Inhibitors (SSRI).
48
®
NANO-LEO Safety
Acute Oral Toxicity Study of NANO-LEO® in
The maximum dose volume administered was 10
Wistar Rats ( Rattus norvegicus)
mL/kg body weight. Both the sets of rats were
The design of this study was based on the
dosed with the starting dose of 2000 mg/kg body
requirements of OECD Guideline
for Testing of Chemicals - Acute
weight. All animals are of age 8-10
weeks at the time of dosing. All
Oral Toxicity Study (Acute
animals were observed for
Toxic Class Method) No. 423,
clinical signs during first 30
adopted 17th December,
minutes and at approximately
2001.
This study was
1, 2, 3 and 4 hours, after
performed at Bioanalytical lab
treatment on day 0 and once
of Sanzyme ltd., India; a
daily for 14 days after dosing.
CPCSEA approved animal facility,
following all ethical practices as laid
down in the guidelines for animal care. This
No adverse signs were observed
throughout the experimental period.
study has been approved by the Institutional
Animals Ethics Committee (IAEC) of the
test facility .
Dosing procedure
Conclusion : LD50 (Cut off value) : 5000 mg/kg body weight and is classified as Category 5
or Unclassified. LD50 is greater than 2000 mg/kg body weight.
NANO-LEO® is hence proved to be SAFE
- Data on file
Prosexual Nutrient
Improves Hormones
( Testosterone, DHEA )
Improves Circulation
( NO mediated )
Improves Neurotransmitters
( Dopamine, Norepinephrine )
The Comprehensive
support for
Libido
Erection
Orgasm
Sanzyme Ltd.
Healthcare Business
Plot No.13. Sagar Society, Road No.2, Banjara Hills, Hyderabad-500 034
www.nanoleo.com
Prosexual Nutrient
Tribulus terrestris, Mucuna pruriens, Ginkgo biloba,
Yohimbe bark, Zinc, L-Arginine
ve
i
t
c
e
EfFf E
&
SAFSE A
Sanzyme Ltd.
Healthcare Business
For further Information Please contact
[email protected]
www.sanzyme.com
Disclaimer : No part of this (Data on file), can be published without prior permission of the author and sponsors of the study.
This book is intended completely to share knowledge

All about - NANO-LEO

Transcription

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