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Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers

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Purified Shilajit, an Ayurvedic rasayana, was evaluated in healthy volunteers of age between 45 and 55 years for its effect on male androgenic hormone viz. testosterone in a randomised, double-blind, placebo-controlled clinical study at a dose of 250 mg twice a day. Treatment with Shilajit for consecutive 90 days revealed that it has significantly (P < 0.05) increased total testosterone, free testosterone and dehydroepiandrosterone (DHEAS) compared with placebo. Gonadotropic hormones (LH and FSH) levels were well maintained.
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Clinical evaluation of purified Shilajit on testosterone
levels in healthy volunteers
S. Pandit, S. Biswas, U. Jana, R. K. De, S. C. Mukhopadhyay & T. K. Biswas
Research Unit, Department of Health and Family Welfare, J. B. Roy State Ayurvedic Medical College and Hospital, Government of West Bengal,
The West Bengal University of Health Sciences, Kolkata, India
Tuhin Kanti Biswas, Research Unit, J. B. Roy
State Ayurvedic Medical College and Hospi-
tal, 170-172, Raja Dinendra Street, Kolkata
700004, India
Tel.: +91-9433173272;
Accepted: July 27, 2015
doi: 10.1111/and.12482
Purified Shilajit, an Ayurvedic rasayana, was evaluated in healthy volunteers of
age between 45 and 55 years for its effect on male androgenic hormone viz.
testosterone in a randomised, double-blind, placebo-controlled clinical study at
a dose of 250 mg twice a day. Treatment with Shilajit for consecutive 90 days
revealed that it has significantly (P<0.05) increased total testosterone, free
testosterone and dehydroepiandrosterone (DHEAS) compared with placebo.
Gonadotropic hormones (LH and FSH) levels were well maintained.
Purified Shilajit (PS) is used in Ayurveda, indigenous sys-
tem of Indian medicine, as a remedy for several diseases,
particularly chronic diseases. Shilajit is a pale-brown to
blackish-brown exudate that oozes from sedimentary
rocks worldwide, largely in the Himalayas. Common peo-
ple describe it from their knowledge as pahar-ki-pasina
(sweat of mountains), paharki-khoon (mountain blood),
shilaras (rock juice), asphalt, bitumen, etc. Shilajit is said
to carry the healing power of these great mountains
(David & Vasant, 2001). It is an important drug of the
ancient Ayurvedic materia medica and it is to this day
used extensively by Ayurvedic physicians for a variety of
diseases. Early Ayurvedic writings from the Charaka Sam-
hita (Sharma, 1998) describe Shilajit as a cure for all dis-
eases as well as a Rasayana (rejuvenator) that promises to
increase longevity. It is composed of rock humus, rock
minerals and organic substances that have been com-
pressed by layers of rock mixed with marine organisms
and microbial metabolites (Ghosal, 1994).
Traditional uses of Shilajit primarily focus not only on
diabetes and diseases of the urinary tract, but also on
oedema, tumours, muscle wasting, epilepsy and even
insanity. Modern indications extend to all systems of the
human body with a significant number of additions in the
reproductive and nervous system. Clinical research confirms
many of the properties for which Shilajit has been used
(Talbert, 2004). In Ayurveda, Shilajit is employed for the
management of male reproductive disorders, and in par-
ticular, under the parlance of Vrisya (an aphrodisiac with
special reference to spermatogenesis) (Sharma, 1998).
Several toxicological studies, both acute and sub-
chronic, have already been performed by many scientists
with Shilajit throughout the world. Oral LD50 was found
to be >2000 mg kg
(Acharya et al., 1988; Ghosal et al.,
1989), and Shilajit was proved to be safe at doses of 0.2
1.0 g per kg body weight when used chronically (Kelgin-
baev et al., 1973; Anisimov & Shakirzyanova, 1982; For-
tan & Acharya, 1984; Al-Hamaidi & Umar, 2003).
Clinical evaluation of spermatogenic activity of processed
shilajit in oligospermia (Biswas et al., 2009) revealed that
there was no alteration on objective features related to
any systemic toxicities such as serum urea, uric acid,
serum bilirubin, total protein, serum globulin, SGPT,
SGOT and alkaline phosphatase (Biswas et al., 2009).
Besides, it was also observed that there was a significant
(P<0.001) improvement in spermia (+37.6%), total
sperm count (+61.4%), motility (12.417.4% after differ-
ent time intervals), normal sperm count (+18.9%) and
total testosterone (+23.5%) with concomitant decrease in
pus and epithelial cell count compared with baseline
value in 28 patients of oligospermia after 90 days of treat-
ment with PS at a dose of 100 mg twice daily. An
unpublished human safety study of purified Shilajit from
Natreon, Inc., New Brunswick, NJ, USA by the present
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Andrologia 2016, 48, 570–575
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and
distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
authors has demonstrated the safety of this product at
250 mg twice a day dosing (Jana, Utpalendu, Biswas,
Tuhin; J.B.Roy Ayurvedic Medical College and Hospital,
Kolkata, India, Project No.: JBR/Res/01/2007), and an
unpublished animal study in rats with 100 mg/kg b.w.
(equivalent to human dose of 850 mg) by Natreon
showed a significant increase in testosterone levels. Thus,
a dose of 250 mg twice daily was selected for this study.
Materials and methods
Preparation and analysis of the drug
Purified Shilajit (PrimaVie
, Kolkata, West Bengal,
India), a patented (US 6,440,436, 6,969,612, 6,558,712, EP
1 387 614) standardised extract of native Shilajit from
Natreon, Inc., was used for the study. Shilajit was stan-
dardised to contain not less than 60% w/w of total bioac-
tives, which include not less than 50% w/w of fulvic acids
(FAs), not less than 0.3% w/w of dibenzo a-pyrones
(DBPs) and not less than 10% w/w of dibenzo-a-pyrone
chromoproteins (DCPs), as quantified by HPLC using
external standards (isolated from Shilajit extract by low
pressure (Lobar) chromatography). An HPLC chro-
matogram of this product is shown in Fig. 1.
Selection of healthy volunteers
The clinical trial was conducted between December 2012
and March 2014 at J. B. Roy State Ayurvedic Medical
College and Hospital, Kolkata, India, after obtaining
necessary permission from Institutional Ethics Commit-
tee (IEC) of J. B. Roy State Ayurvedic Medical College
and Hospital, Kolkata, India. A schematic of the study
design is shown in Fig. 2. Healthy volunteers aged
between 45 and 55 years, irrelevant of religion, income
status and occupation, were selected for the present pur-
pose, and the distribution of patients was done by the
method of double-blind randomised techniques. Initially,
145 volunteers were selected on the basis of primary
assessment eligibility and 49 among them were excluded
for various reasons (Fig. 2). A total of 96 volunteers
were enrolled in the present trial and randomly divided
into two equal groups as PS treated and placebo treated,
each with 48 subjects. In the course of the study, 21
subjects discontinued for various reasons and 38 subjects
in PS-treated group and 37 subjects in the placebo
group completed the study (Fig. 2). Mean age of the
volunteers was 49.44 years in the test drug group and
48.89 years in the placebo group, and thus, there is no
bias due to the difference in mean ages. Volunteers were
included in the study after taking their consent in trilin-
gual (English, Bengali and Hindi) using prescribed for-
mat of WHO-Helsinki rules. History of volunteers was
taken according to the standard protocol mentioning
name, age, sex, religion, address, occupation, income
status, history of past illness, family history, personal
history, marital history, general examination, systemic
examination, laboratory investigation, etc.
Dosage regimen
Both the groups received respective drugs in the dose of
250 mg/capsule orally, twice daily after major meals, for a
2.00 4.00 6.00 8.00 10.00 12.00 14.00 16.00 18.00
20.00 22.00 24.00 26.00 28.00 30.00
Fig. 1 HPLC chromatogram of Shilajit (PrimaVie
) by RP-C 18 column. Fulvic acids (FAs) t
: 2.03.0 min; Dibenzochromo proteins (DCPs) t
3.05.8 min; 3,8 -(OH)
Dibenzo-a-pyrone t
: 9.07 min; 3-OH- Dibenzo-a-pyrone t
: 26.02 min. HPLC analysis was performed under ambient
conditions, with Waters HPLC equipment comprising Waters 515 pumps, Waters photodiode array detector (PDA) model 2996, Waters pump
controller module and EMPOWER software (version 1) Natreon Inc., New Brunswick, New Jersey, USA. Samples (20 ll) were injected by means of a
Rheodyne injector fitted with a 20-ll loop. Compounds were separated on a C18 reverse-phase (Lichrocart
column (250 mm 94 mm, i.d., 5-
lm particle; column no 331303, Darmstadt, Germany) using the mobile phase Water : Acetonitrile : o-phosphoric Acid [67 : 32 : 01 v/v/v] with a
flow rate of 0.8 ml/min. The UV absorbance of eluent was monitored at a wavelength of 240 nm.
©2015 The Authors. Andrologia Published by Blackwell Verlag GmbH 571
Andrologia 2016, 48, 570–575
S. Pandit et al. Clinical evaluation of Shilajit on testosterone
total duration of 90 days. Distribution of treatment is as
Group I: PS 250 mg BID (38 subjects)
Group II: Placebo 250 mg (microcrystalline cellulose
124 mg + lactose 124 mg + magnesium
stearate 2 mg) BID (37 subjects)
Both the PS and placebo capsules were white opaque,
Size 1, and looked identical.
Inclusion/exclusion criteria
Eligibility was based on the following inclusion criteria:
Clinically examined normal healthy volunteers, devoid of
any chronic, organic or dreadful diseases, irrespective of
religion and income status with age between 45 and
55 years, not taking any supplements or vitamins and
male subjects. The exclusion criteria were volunteers of
age below 45 years and above 55 years, any chronic,
organic or dreadful diseases, concomitant serous disor-
ders, other drug treatment being received simultaneously
on long basis which may affect the study results, any
immunosuppressive drugs being received, poor nutri-
tional status, subjects likely to fail compliance with the
trial protocol, alcoholism, smoking, using antipsychotic
drugs and steroids/male contraceptives.
Observation criteria
Screening and diagnosis
Ageing men often present with a variety of vague nonspeci-
fic symptoms that may be associated with testosterone defi-
ciency (Nandy et al., 2008). Subjects were, therefore,
screened on the basis of the St Louis University ADAM
Selection assessment for eligibilty
Excluded (n= 49)
Not meeting inclusion criteria (n = 28)
Refuse to sign consent form (n = 09)
Other reason (n =12)
Enrolment for treatment allocation (n = 96)
0 day : Testosterone,
Free testosterone, FSH,
PS 250 mg kg–1 BD (n = 48) Comparator (n = 48)
30 day : Testosterone,
Free testosterone, FSH,
60 day : Testosterone,
Free testosterone, FSH,
90 day : Testosterone,
Free testosterone, FSH,
Protocol completed
PS (n = 38)
Comparator (n = 37)
Discontinued (n = 21)
Protocol violation (n = 03)
Follow up (n =14)
Physician’s decision (n = 04)
Fig. 2 Schematics of study design.
572 ©2015 The Authors. Andrologia Published by Blackwell Verlag GmbH
Andrologia 2016, 48, 570–575
Clinical evaluation of Shilajit on testosterone S. Pandit et al.
questionnaire (Table 1) (Morales et al., 2000). Besides the
ADAM questionnaire, normalcy of the subjects was estab-
lished after receiving acceptable ranges of different haema-
tological and biochemical parameters such as fasting
glucose, serum urea, creatinine, ALT, AST, Hb%, total
RBC, total and differential counts of WBC, RBC/WBC
morphology, ESR and routine stool examination including
occult blood test. Biochemical investigations were per-
formed by means of auto-analyser (Beckman Coulter, CA,
USA), and haematological investigations were done by
means of automated cell counter (Medonic CA 530 16;
Oden (Merck, Germany). Routine stool examination was
carried out by means of conventional methods.
Estimation of testosterone, free testosterone, LH, FSH and
Both total and free testosterones, LH, FSH and DHEAs
were estimated from fasting blood of each volunteer on
days 0 (baseline), 30, 60 and 90. LH and FSH were esti-
mated by means of ADVIA Centaur XP Immunoassay
Systems (SIEMENS, Berlin, USA) with ADVIA Centaur
LH ready pack primary reagent; testosterone and DHEAs
were estimated by means of Access Immunoassay System
(Beckman Coulter) with Access Testosterone Reagent
Pack and Access DHEAs Reagent Pack respectively. Free
testosterone was estimated by means of AccuBind ELISA
Microwells Test system (Monobind Inc., Lake Forest, CA,
USA) with AccuBind free testosterone reagent pack.
Statistical analyses
Statistical analysis of data of the two treatment groups
collected at different intervals of study was performed by
paired Student’s ‘t-’test using SPSS11.5 version software
(Chicago, USA).
Subject screening
All subjects responded ‘yes’ to questions 1 and 7 or
any three other questions according to the ADAM
questionnaire were primarily selected. Besides, they also
fulfil all inclusion criteria. Fasting glucose, renal investi-
gations like serum urea and creatinine, hepatic investi-
gations like ALT and AST, haematological parameters
and stool investigations were found within normal
range during primary screening for the inclusion of the
Treatment efficacy
A total of 21 subjects discontinued the study, and any
data from these subjects were not included in the calcula-
tions as these subjects discontinued at different time
points of the study and for various reasons.
Testosterone and free testosterone estimation
It was observed that in PS-treated group, there was an
increase in testosterone levels (ng ml
) on days 30
(6.82%), 60 (3.09%) and 90 (20.45%) with respect to day
‘0’. The increment of testosterone levels on day ‘90’ was
significant (P<0.05) with respect to the values of day
‘0’. In placebo-treated group, there was a significant
(P<0.05) decreasing trend of testosterone level. The level
of testosterone in PS-treated group on day 90 was found
to be significantly (P<0.05) better than the values of
placebo-treated group in same day (Table 2). The level of
free testosterone (pg ml
) in PS-treated group on day
90 (19.14%) was significantly better (P<0.05) than
0 day value and maintain parity with the testosterone
level. Free testosterone level of PS-treated group on day
90 was also found to be significantly higher (P<0.05)
with the values of placebo-treated group on same day
(Table 2).
LH and FSH estimation
LH (mIU ml
) and FSH (mIU ml
) are inter-related
hormones, which have role in synthesis and release of
testosterone. In the present research work, it was observed
that there was maintenance of LH level in PS-treated
group, while FSH level significantly increased (P<0.004)
in PS-treated group on days 30, 60 and 90 with respect
to baseline. The result of FSH was significantly better in
PS-treated group than placebo group on day 90
(Table 2).
Table 1 The St Louis University ADAM questionnaire for screening of
testosterone deficiency
Sl Questionnaires Comments
1 Do you have a decrease in libido (sex drive)? Yes / No
2 Do you have a lack of energy? Yes / No
3 Do you have a decrease in strength
and/or and endurance?
Yes / No
4 Have you lost height? Yes / No
5 Have you noticed a decreased ‘enjoyment of life’? Yes / No
6 Are you sad and/or grumpy? Yes / No
7 Are your erections less strong? Yes / No
8 Have you noticed a recent deterioration
in your ability to play sports?
Yes / No
9 Are you falling asleep after dinner? Yes / No
10 Has there been a recent deterioration in
your work performance?
Yes / No
Test is considered positive if answers are ‘Yes’ to question 1, question
7, or any 3 other questions.
©2015 The Authors. Andrologia Published by Blackwell Verlag GmbH 573
Andrologia 2016, 48, 570–575
S. Pandit et al. Clinical evaluation of Shilajit on testosterone
DHEAs estimation
DHEAs, the precursor of testosterone, showed interesting
results with PS, where the level of DHEAs (lgdl
) grad-
ually increased on day 30 (9.14%), 60 (9.59%) and 90
(31.35%) with respect to values on day ‘0’. Change of
DHEAs in placebo group was irregular. However, the
level of increase in DHEA in PS-treated group on day 90
was found to be significantly higher (P<0.05) than base-
line value of PS-treated group and 90-day value of pla-
cebo (Table 2).
Testosterone is an anabolic steroid synthesised primarily
by the Leydig cells in the testes in males, the ovaries in
females and adrenal glands in both sexes. It is synthesised
from cholesterol, with androstenedione, androstenediol,
dehydroepiandrosterone sulphate (DHEAs), progesterone
and pregnenolone acting as some of the intermediate sub-
strates. Testosterone production is regulated by hormonal
secretions from the hypothalamus and the pituitary gland
in the brain via hypothalamuspituitarytesticular axis.
The process begins as the hypothalamus secretes gonado-
tropin-releasing hormone (GnRH) in generative pulses.
In response to these steady intermittent bursts of GnRH,
the pituitary gland releases luteinising hormone (LH) and
follicle-stimulating hormone (FSH), which act directly on
the testes. FSH activates the Sertoli cells that produce
sperm (spermatogenesis). LH stimulates the Leydig cells
to secrete testosterone in a daily rhythm characterised by
peak levels in the morning and low levels in the evening.
Once it reaches high levels, testosterone production gen-
erates negative loop feedback to the hypothalamus to
downregulate LH release and diminish further testos-
terone production. In this way, testosterone inhibits its
own secretion (Gingrich, 2010). In addition to hypothala-
mic influence, it has been found that testosterone has
direct negative feedback effects on the anterior pituitary
gland. Like most hormones, testosterone is supplied to
target tissues in the blood where much of it is trans-
ported bound to a specific plasma protein, sex hormone-
binding globulin (SHBG) (Brooks, 1975). Most circulat-
ing testosterone is bound by SHBG and albumin; approx-
imately 2% of total testosterone is free (not bound to
protein). SHBG-bound testosterone is so tightly bound
that it is not biologically active. Both free and albumin-
bound testosterones are biologically active and together
are referred to as the bioavailable fraction (Bhasin et al.,
2010). It is reported that the total, free and bio-available
testosterone varies widely in the age group between 1869
and 7089 (Rosner et al., 2007). In the current study,
total and free testosterones were estimated to establish
the efficacy of PS for its role on testosterone stimulation
and secretion property considering the reference range 4
30 pg ml
for free testosterone and 1.757.81 ng ml
for testosterone (total testosterone). DHEAs, the main
precursor of testosterone, was also estimated to rationalise
the role of PS on testosterone synthesis considering refer-
ence range 70495 lgdl
between the age group of 41
50 years and 38313 lgdl
between the age group of
5160 years. The present research work reveals that PS
may be able to increase both total testosterone and free
testosterone with respect to baseline value indicating its
potentiality on testosterone secretion level. The significant
betterment of DHEAs with the treatment of PS signifies
its role on testosterone synthesis. Other two gonadotropic
hormones, viz. LH and FSH, were studied in this present
work, to rationalise the hypothalamo-pituitarytesticular
axis, where both of these hormones were in maintained
levels indicating their initial role of triggering of testos-
terone production. This was followed by downregulation
of LH and FSH on one hand and maintenance of the
hypothalamo-pituitarytesticular axis by means of ele-
vated level of testosterone on 30, 60 and 90 days on the
Table 2 Effect of PS on testosterone and its mediators with respect to placebo control
PS (250 mg BID) (n=38) Placebo (250 mg BID) (n=37)
Baseline 30 days 60 days 90 days Baseline 30 days 60 days 90 days
(ng ml
(1.54) 5.17 (1.33) 4.99 (1.41) 5.83
(1.67) 5.82
(1.58) 4.88
(1.74) 4.58
(1.44) 4.45
Free Testosterone
(pg ml
(7.17) 14.20 (3.97) 14.14 (3.59) 18.30
(7.72) 19.30
(5.75) 15.03
(4.22) 14.52
(6.19) 12.21
LH (mIU ml
) 6.33 (3.88) 6.65 (3.95) 6.64 (3.81) 6.79 (3.67) 6.49 (3.32) 7.82 (5.71) 5.86 (2.66) 7.45 (5.90)
FSH (mIU ml
) 6.94 (3.52) 8.17
(4.15) 8.52
(4.41) 8.41
(4.61) 6.91 (6.35) 8.11 (6.06) 7.46 (5.53) 10.23 (11.77)
DHEA-S (lgdl
) 145.09
P<0.05 considered as significant level in paired and unpaired Student’s t-test.
Compare to 0 day value of same group.
Compare to placebo group.
574 ©2015 The Authors. Andrologia Published by Blackwell Verlag GmbH
Andrologia 2016, 48, 570–575
Clinical evaluation of Shilajit on testosterone S. Pandit et al.
other hand. All these modus operandi of PS on synthesis
and stimulation of testosterone are found to be better
than placebo-treated group in healthy male volunteers in
age group of 4555 years, who may undergo andropause
in normal course. Placebo, composed with microcrys-
talline cellulose, lactose and magnesium stearate, has nei-
ther stimulation nor inhibiting role on testosterone
secretion or synthesis.
Processed Shilajit (PS) containing biologically active
component di-benzo-alpha-pyrone (DBP) is earlier
reported to increase the spermatogenic activity in selected
patients of oligospermia (Biswas et al., 2009), and the
current study demonstrates that purified Shilajit increases
the total and free testosterone levels in healthy volunteers.
The present study was conducted to evaluate the efficacy
of PS for testosterone secretion and stimulation effects on
normal healthy volunteers in the age group of 45
55 years. This effect was clarified by estimation of free
and total testosterone on 0, 30, 60 and 90 days where the
rise of these two androgenic markers was significant.
Testosterone synthesis and secretion was supported by the
maintenance levels of two gonadotropic hormones LH
and FSH as well as elevation of testosterone precursor
We acknowledge Natreon Inc, Premise No: 02-360, Rishi
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Kolkata 700 156, for financial support to carry out the
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S. Pandit et al. Clinical evaluation of Shilajit on testosterone
... Analysis of LN18178 was carried out using an HPLC system equipped with a thermostat-controlled column oven compartment, autosampler, photodiode array detector, and Empower 3 software (Waters Corporation, Milford, MA). The sample preparation involves the extraction of the sample using watermethanol (80: 20), followed by filtration through a 0.22 µm PVDF filter. The sample solution was analyzed using Phenomenex, Gemini NX C18 column (3.0 µm; 150 × 4.6 mm). ...
... In calculating sample size, a mean difference of 22 pmol/L and a common standard deviation of 28.2 for free testosterone; and a mean difference of 4.9 nmol/L and a common standard deviation of 5.9 for total testosterone was considered. These estimates were based on a clinical study that evaluated the effect of an Ayurvedic ingredient (Shilajit) on testosterone levels in healthy males (20). Based on the power calculation, a minimum of twenty-seven subjects per group was estimated to have 80% power to detect the significant effect of LN18178 supplementation in testosterone level (free and total). ...
... The objective of the current study was to assess whether the herbal blend increased serum testosterone level and, notably, its tolerability in the young male participants. The number of volunteers in each group of the present study was estimated based on the outcome from a published clinical study of a popular dietary supplement (Shilajit) on testosterone levels in healthy males (20). Although plants are natural resources rich in various medicinal properties, concerns on the side effects of long-term use of many plant-based products are growing (21,22). ...
LN18178 is a proprietary herbal blend containing extracts of Punica granatum fruit rind and Theobroma cocoa seeds. The objective of the present study was to evaluate the effect of LN18178 on serum testosterone levels in healthy young adults in a randomized, double-blind, placebo-controlled study. One hundred and twenty male volunteers (age 21-35 years) were randomized into three groups. Each group (n = 40) received a daily dose of either placebo or 200 or 400 mg LN18178 for fifty-six days. An increase in serum testosterone (free and total) was the primary efficacy measure of the study. The secondary measures included dihydrotestosterone (DHT), cortisol, Luteinizing hormone (LH), 17β-Estradiol (E2), hand grip strength, and the mid-upper arm circumferences (MUAC). The vital signs and clinical chemistry parameters in blood and urine were performed to determine product safety. Post-intervention, both doses of LN18178 significantly increased free testosterone (p < 0.0001 vs. baseline; p = 0.0268 and p < 0.0001, respectively vs. placebo). The high dose group showed significant increases in total testosterone (p < 0.0001 vs. baseline; p = 0.0184 vs. placebo) and luteinizing hormone (p < 0.0007 vs. baseline; p = 0.0470 vs. placebo). The changes in other hormones were not significant. At post-trial, the LN18178-400 group showed significant improvements in the hand grip strength and mid-upper arm circumference. The hemato-biochemical parameters, urinalysis, and vital signs of the participants were within the normal range. Together, these observations suggest that LN18178 is a safe and tolerable herbal blend; it increases testosterone level and increases muscle strength and MUAC in young, healthy males. Supplemental data for this article is available online at .
... Shilajit is traditionally used to treat various diseases such as gastric ulcers, diabetes mellitus, osteoporosis with fractures, erectile dysfunction (impotence), nephrolithiasis, neuropsychological stress, and cardiovascular diseases [2,3]. Many scientific investigations conducted on the biological influences of Shilajit revealed that it endowed with antioxidant [4], antihyperglycemic [5], antiinflammatory [6], adaptogenic ‫7[‬ ], gastroprotective [7], spermatogenic [8,9], and cardioprotective [10] effects. These biological effects relied on specific bioactive agents like fulvic acids (FAs) and the dibenzo-alpha-pyrones (DBPs) and its chromoproteins (DCPs) [3]. ...
... Shilajit was used as an aphrodisiac substance and studied for male infertility treatment. The stimulant effects of the spermatogenic activity in infertile men [8] and healthy men [9] were demonstrated via recovering spermatogenesis Content courtesy of Springer Nature, terms of use apply. Rights reserved. ...
... abnormalities, the degraded spermatozoa qualities (count and motility), and the lower serum levels of follicle-stimulating hormone (FSH) [8] and testosterone [8,9]. On the other hand, Pb and Hg in Shilajit could accumulate and induce impairments to the male reproductive systems. ...
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Shilajit is used commonly as Ayurvedic medicine worldwide which is Rasayana herbo-mineral substance and consumed to restore the energetic balance and to prevent diseases like cognitive disorders and Alzheimer. Locally, Shilajit is applied for patients diagnosed with bone fractures. For safety of the patients, the elemental analysis of Shilajit is imperative to evaluate its nutritional quality as well as contamination from heavy metals. The elemental composition of Shilajit was conducted using three advanced analytical techniques (LIBS, ICP, and EDX). For the comparative studies, the two Shilajit kinds mostly sold globally produced in India and Pakistan were collected. Our main focus is to highlight nutritional eminence and contamination of heavy metals to hinge on Shilajit therapeutic potential. In this work, laser-induced breakdown spectroscopy (LIBS) was applied for qualitative and quantitative analysis of the Shilajit. Our LIBS analysis revealed that Shilajit samples composed of several elements like Ca, S, K, Mg, Al, Na, Sr, Fe, P, Si, Mn, Ba, Zn, Ni, B, Cr, Co, Pb, Cu, As, Hg, Se, and Ti. Indian and Pakistani Shilajits were highly enriched with Ca, S, and K nutrients and contained Al, Sr, Mn, Ba, Zn, Ni, B, Cr, Pb, As, and Hg toxins in amounts that exceeded the standard permissible limit. Even though the content of most elements was comparable among both Shilajits, nutrients, and toxins, in general, were accentuated more in Indian Shilajit with the sole detection of Hg and Ti. The elemental quantification was done using self-developed calibration-free laser-induced breakdown spectroscopy (CF-LIBS) method, and LIBS results are in well agreement with the concentrations determined by standard ICP-OES/MS method. To verify our results by LIBS and ICP-OES/MS techniques, EDX spectroscopy was also conducted which confirmed the presence above mentioned elements. This work is highly significant for creating awareness among people suffering due to overdose of this product and save many human lives.
... We were able to find only one RCT regarding shilajit that met the inclusion criteria. In a study by Pandit et al., healthy adults in the treatment group (n = 38, age 49.4 years) received purified shilajit (250 mg twice a day for 90 days) and 37 healthy adults in the control group (age 48.9 years) received a placebo [29]. As a result, the authors concluded, that the treatment with shilajit for a consecutive 90 days significantly increased total testosterone, free testosterone, and dehydroepiandrosterone (DHEAS) compared with a placebo [29]. ...
... In a study by Pandit et al., healthy adults in the treatment group (n = 38, age 49.4 years) received purified shilajit (250 mg twice a day for 90 days) and 37 healthy adults in the control group (age 48.9 years) received a placebo [29]. As a result, the authors concluded, that the treatment with shilajit for a consecutive 90 days significantly increased total testosterone, free testosterone, and dehydroepiandrosterone (DHEAS) compared with a placebo [29]. ...
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“Testosterone boosters” (TB)—are supplements that are claimed to increase testosterone levels in the human body. While the consumption of TB may be popular among athletes, there is insufficient evidence both about the safety and the real efficacy of TB. In our review, we searched MEDLINE/PubMed and Cochrane Library for studies on the effects of 15 substances that are claimed to increase testosterone levels Anacyclus pyrethrum; Bulbine natalensis; Epimedium (horny goat weed); L-arginine; L-carnitine; magnesium; Mucuna pruriens; pantothenic acid; selenium; shilajit Eurycoma longifolia (Tongkat Ali); Serenoa repens (saw palmetto); boron; Withania somnifera (ashwagandha); and Trigonella foenum-graecum (fenugreek) in athletes and healthy adults under 55 years of age. We found such studies regarding 10 out of 15 substances: L-arginine (3 studies); L-carnitine (2); magnesium (1); selenium (2); shilajit (1); Tongkat Ali (2); Serenoa repens (1); boron (3); ashwagandha root (2); and fenugreek (7). Many of them fail to prove the efficacy of these substances to increase testosterone levels. Tongkat Ali, ashwagandha, and fenugreek were the substances with the strongest evidence. The positive effect of magnesium and shilajit on testosterone concentration was shown in single studies. Conflicting data found that L-arginine, L-carnitine, Serenoa repens, selenium and boron do not appear to increase testosterone levels. There are almost no data on the safety profile of various TB components; however, certain TB components may be linked to coagulation, and pancreatic and hepatic disorders. Based on the review, the authors conclude that at present TB cannot be recommended for use by athletes due to insufficient data on their efficacy and safety. Lazarev A, Bezuglov E. Testosterone Boosters Intake in Athletes: Current Evidence and Further Directions. Endocrines. 2021; 2(2):109-120.
... [20], [21] Chandraprabha Vati has been classically used in the disorders of urinary and reproductive system. In a study, it has shown promising result in the management of necrozoospermia. ...
... Gonadotropic hormones levels are well maintained 46 . In an animal study on adults Lohi rams, administration of Shilajit may lead to increase significantly (P<0.05) in volume, numbers of sperms, motility percentage, mass activity and scrotal circumference of the testes and decrease in pH and dead percentage of sperms [47] . In a clinical evaluation, significant improvement in spermia (+37.6%), ...
... Firstly, as shown by Gupta (1966), Shilajit increases glomerular filtration due to its diuretic effect, leading to a decrease in urea level. Secondly, as some studies have reported, Shilajit has similar properties to anabolic steroids and thus its extract can reduce urea levels (Pandit et al., 2016). Another finding of this study was that the blood glucose level decreased in the Shilajit control group compared to other groups, indicating the hypoglycemic and anti-diabetic properties of the Shilajit extract (Gupta, 1966;Talbert, 2004). ...
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The present study investigated the effects of Shilajit extract on aspirin‐induced gastric lesions in rats. We evaluated macroscopic and histopathological lesions in the stomach, measured the activity of oxidative stress enzymes in gastric tissue homogenates, and assessed serum electrolytes and parameters of kidney and liver function. Forty‐five male rats were allocated to five groups: Normal control, positive control, omeprazole treatment, Shilajit treatment, and Shilajit control. The treatment period lasted for four consecutive days. The size and number of gastric lesions were significantly reduced in the Shilajit and omeprazole groups compared to the positive control group, indicating a reduction in mucosal damage and the severity of edema and leukocyte infiltration in tissue sections. A significant increase was observed in the levels of all oxidative stress parameters, except malondialdehyde, in rats treated with Shilajit and omeprazole compared to those in the positive control group. The effect of the aqueous extract of Shilajit was comparable to that of omeprazole. These results indicated the protective effects of Shilajit against aspirin‐induced gastric lesions. This study demonstrated that Shilajit extract can alleviate aspirin‐induced gastric mucosal damage by increasing the activities of antioxidant enzymes. Therefore, it can be used as a gastric mucosal protective agent.
... Clinical studies in humans have proven the hypolipidemic, antioxidant and cardioprotective activities of P. emblica. [27][28][29][30][31][32][33] Shilajit, a rock exudate containing free and chromoprotein-conjugated dibenzo-α-pyrones (urolithins) and fulvic acids as bioactives, finds broad use in Ayurveda for different clinical applications, such as improving cardiovascular health, upregulating collagen and related extracellular matrix protein genes [34][35][36][37][38] Shilajit seems to induce the growth of blood vessels 39 and has a prominent cardioprotective effect. 40 A clinical study with ω-3FA, in combination with another product, to broaden the spectrum of cardiovascular benefits of ω-3FA in T2DM, without increasing the size or cost of the dosage form significantly, is warranted. ...
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Purpose: This study was conducted to evaluate the effectiveness of fish oil alone and with an adjunct, a proprietary chromium complex (PCC), on cardiovascular parameters - endothelial dysfunction, lipid profile, systemic inflammation and glycosylated hemoglobin - in a 12-week randomized, double-blind, placebo-controlled clinical study in type 2 diabetes mellitus subjects. Patients and methods: In this randomized, double-blind, parallel group study, 59 subjects in three groups completed the study: Group A, fish oil 2000 mg; Group B, fish oil 2000 mg + PCC 10 mg (200 µg of Cr3+); and Group C, fish oil 2000 mg + PCC 20 mg (400 µg of Cr3+) daily for 12 weeks (2000 mg of fish oil contained 600 mg of eicosapentaenoic acid [EPA] and 400 mg of docosahexaenoic acid [DHA], the omega-3 fatty acids). Endothelial function, by estimating reflection index (RI), biomarkers of oxidative stress (nitric oxide [NO], malondialdehyde [MDA], glutathione [GSH]) and inflammatory biomarkers (high-sensitivity C-reactive protein [hsCRP], intercellular adhesion molecule-1 [ICAM-1], vascular cell adhesion molecule-1 [VCAM-1], endothelin-1) were evaluated at baseline, and 4 and 12 weeks. Lipid profile, platelet aggregation and glycosylated hemoglobin [HbA1c) were tested at baseline and 12 weeks. Any reported adverse drug reactions were recorded. Statistical analysis was performed using GraphPad Prism 8. Results: The present study shows that fish oil by itself, at a dose of 2000 mg (600 mg of EPA + 400 mg of DHA) per day, led to significant, but only modest, improvement in cardiovascular parameters (RI from -2.38±0.75 to -3.92±0.60, MDA from 3.77±0.16 to 3.74±0.16 nM/mL, NO from 30.60±3.18 to 32.12±3.40 µM/L, GSH from 568.93±5.91 to 583.95±6.53 µM/L; p≤0.0001), including triglyceride levels. However, when PCC was added to fish oil, especially at the 20 mg dose, there were highly significant improvements in all the parameters tested (RI from -2.04±0.79 to -8.73±1.36, MDA from 3.67±0.39 to 2.89±0.34 nM/mL, NO from 28.98±2.93 to 40.01±2.53 µM/L, GSH from 553.82±8.18 to 677.99±10.19 µM/L; p≤0.0001), including the lipid profile. It is noteworthy that the triglycerides were decreased significantly by addition of 20 mg of PCC although the dose of fish oil was only 2 g/day and the baseline triglyceride levels were only about 200 mg/dL. Fish oil alone did not significantly decrease the HbA1c, whereas the addition of 20 mg of PCC did. Conclusion: Addition of PCC, especially at 20 mg dose, significantly improves the efficacy of fish oil in addressing cardiovascular risk factors compared to fish oil given alone.
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Background : Male factor infertility often results from testicular disorders leading to inadequate sperm quantity and quality. Both beneficial and detrimental effects of botanical products, especially herbal medicines, on testicular functions and male fertility have been reported in the literature. Purpose : This scoping review aims to map the main clinical evidence on the different impacts of botanical entities on the testis and to critically appraise relevant randomized controlled trials (RCTs) published in the recent 5 years, so as to inform the future. Methods : Systematic reviews, meta-analyses and RCT reports on botanical impacts on testicular functions and male fertility were retrieved and synthesized from Pubmed, Web of Science, Scopus, Embase, ProQuest, Cochrane Library and Google Scholar up to 10th May 2022. RCTs published since 2018 were critically appraised against good practice guidelines for RCT and for reporting herbal studies. Results : We identified 24 systematic reviews and meta-analyses published since 2005, by authors from Iran (25%), China (21%), USA (12.5%) and 9 other countries. All but two were published in English. Only 3 systematic review protocols were identified, all published in English from China in the recent 3 years. We identified 125 RCTs published in six languages, mainly English (55%) and Chinese (42%). They were published since 1994 from 23 countries on all the six inhabitable continents, with China (46%), Australia (8%), USA (8%), India (7%) and Iran (5%) being the leading contributors. 72% and 28% RCTs published in English were on efficacy (botanicals vs placebo) and comparative effectiveness (one botanical vs other treatments), respectively. In contrast, 98% RCT reports in Chinese were on comparative effectiveness, with merely 2% on efficacy. Among all the 125 RCTs, 57% were studies in men with semen abnormality and/or male infertility, 22% investigated herbal effects in healthy men, 14% were in men with male sexual dysfunction and hypogonadism, and 7% were conducted in men with non-sexual disorders. Since 2018, 32 RCTs have been published, in English (69%) or Chinese (31%). Nineteen RCT reports from China, India, Japan and Korea all studied herbal formulae while the 13 RCT reports from Australia, Brazil, Czech and Italy, Iran, Malaysia, Spain, the UK and the USA all exclusively studied extracts of a single species. Putting geo-cultural differences aside, gossypol and extracts of Tripterygium wilfordii Hook. f. were found to be detrimental to the testis and male fertility, while the extracts of Withania somnifera (L.) Dunal and traditional Chinese medicine Qilin Pill, etc., might improve testosterone levels and semen parameters, thus could be therapeutic for male sexual dysfunction and infertility. However, all still require further evaluation in view of recurring weaknesses in quality control of herbal materials, RCT design and reporting. For example, only 9%-23% of the RCTs published since 2018 provided information on voucher samples, chemical profiling, herbal authentication and herbal extraction. Conclusion : Research on botanicals and the testis has been reported worldwide, demonstrating clear geo-cultural differences in studied plant species, botanical types, study objectives and quality of research design, implementation and reporting. Due to a few recurring weaknesses in the literature, this study is unable to recommend the use of any specific botanicals, however, current evidence does indicate that botanicals can be double-edged swords to the testis and male fertility. To secure better clinical evidence, future studies must faithfully implement existing and emerging good practice guidelines.
Testosterone deficiency, defined as low total testosterone combined with physical, cognitive, and sexual signs and/or symptoms, is a common finding in adult men. Functional hypogonadism (FH) is defined as borderline low testosterone (T) secondary to aging and/or comorbid conditions such as diabetes, obesity, and/or metabolic syndrome. The relationship between FH and metabolic disorders is multifactorial and bidirectional, and associated with a disruption of the hypothalamic–pituitary–gonadal axis. Resolution of FH requires the correct diagnosis and treatment of the underlying condition(s) with lifestyle modifications considered first-line therapy. Normalization of T levels through dietary modifications such as caloric restriction and restructuring of macronutrients have recently been explored. Exercise and sleep quality have been associated with T levels, and patients should be encouraged to practice resistance training and sleep seven to nine hours per night. Supplementation with vitamin D and Trigonella foenum-graecum may also be considered when optimizing T levels. Ultimately, treatment of FH requires a multidisciplinary approach and personalized patient care.
Conference Paper
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The high PUFA content in cock semen is essential for normal semen function as it forms semen's fluidity. Therefore, rooster semen is more susceptible to lipid peroxidation (LPO) by reactive oxygen species (ROS) during in vitro use and storage. Antioxidants are the primary defense mechanisms against oxidative stress. Shilajit has an antioxidant effect by protecting it from the damage of free radicals. This study aims to determine the effects of shilajit-containing extender on the freezing of rooster semen. 20 adult Barred Plymouth Rock roosters kept in individual cages at the age of 49 weeks were used in the study. The semen taken from 20 roosters with the abdominal massage technique was pooled at 37 o C. After the preliminary examination, the semen was divided into 6 equal parts. 3% glycerol (v/v) was added as a cryoprotectant to the Beltsville Poultry Semen Extender (BPSE) diluent. The prepared BPSE diluent was divided into 6 equal parts, including 1 control and 5 experimental groups (S5, S10, S15, S20,S25), and shilajit was added to the experimental groups at different rates (5, 10, 15, 20, 25 g/ml) as an antioxidant. Reconstituted semen were allowed to equilibrate for 2 hours at 4 °C. The prepared straws were placed on an aluminum rack and frozen in liquid nitrogen vapor for 7 minutes at the height of 4 cm on the liquid nitrogen surface. Frozen semen straws were thawed at 37 o C in 30 seconds. Motility examination was performed with the CASA system (Microptic Sperm Class Analyzer, SCA). At the end of the solution, Progressive motility values were 7.30% in the control group, 14.36% in the S5 group, 14.15% in the S10 group, 18.83% in the S15 group, 14.36% in the S20 group, and 17.00% in the S25 group.
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Our objective was to update the guidelines for the evaluation and treatment of androgen deficiency syndromes in adult men published previously in 2006. The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, five additional experts, a methodologist, and a medical writer. The Task Force received no corporate funding or remuneration. We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. We suggest the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test. We recommend confirmation of the diagnosis by repeating the measurement of morning total testosterone and, in some men in whom total testosterone is near the lower limit of normal or in whom SHBG abnormality is suspected by measurement of free or bioavailable testosterone level, using validated assays. We recommend testosterone therapy for men with symptomatic androgen deficiency to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density. We recommend against starting testosterone therapy in patients with breast or prostate cancer, a palpable prostate nodule or induration or prostate-specific antigen greater than 4 ng/ml or greater than 3 ng/ml in men at high risk for prostate cancer such as African-Americans or men with first-degree relatives with prostate cancer without further urological evaluation, hematocrit greater than 50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms with International Prostate Symptom Score above 19, or uncontrolled or poorly controlled heart failure. When testosterone therapy is instituted, we suggest aiming at achieving testosterone levels during treatment in the mid-normal range with any of the approved formulations, chosen on the basis of the patient's preference, consideration of pharmacokinetics, treatment burden, and cost. Men receiving testosterone therapy should be monitored using a standardized plan.
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The safety and spermatogenic activity of processed Shilajit (PS) were evaluated in oligospermic patients. Initially, 60 infertile male patients were assessed and those having total sperm counts below 20 million ml(-1) semen were considered oligospermic and enrolled in the study (n = 35). PS capsule (100 mg) was administered twice daily after major meals for 90 days. Total semenogram and serum testosterone, luteinising hormone and follicle-stimulating hormone were estimated before and at the end of the treatment. Malondialdehyde (MDA), a marker for oxidative stress, content of semen and biochemical parameters for safety were also evaluated. Twenty-eight patients who completed the treatment showed significant (P < 0.001) improvement in spermia (+37.6%), total sperm count (+61.4%), motility (12.4-17.4% after different time intervals), normal sperm count (+18.9%) with concomitant decrease in pus and epithelial cell count compared with baseline value. Significant decrease of semen MDA content (-18.7%) was observed. Moreover, serum testosterone (+23.5%; P < 0.001) and FSH (+9.4%; P < 0.05) levels significantly increased. HPLC chromatogram revealed inclusion of PS constituents in semen. Unaltered hepatic and renal profiles of patients indicated that PS was safe at the given dose. The present findings provide further evidence of the spermatogenic nature of Shilajit, as attributed in Ayurvedic medicine, particularly when administered as PS.
The effects of shilajit and the combined effects of its main constituents, fulvic acids (FAs), 4'-methoxy-6-carbomethoxybiphenyl (MCB) and 3,8-dihydroxy-dibenzo-α-pyrone (DDP), were studied in relation to the degranulation and disruption of mast cells against noxious stumuli. Shilajit and different combinations of FAs. MCB and DDP provided statistically significant protection to antigen-induced degranulation of sensitized mast cells, markedly inhibited the antigen-induced spasm of sensitized guinea-pig ileum, and prevented mast cell disruption induced by compound 48/80. The findings are appraised in view of the clinical use of shilajit in the treatment of allergic disorders in Ayurvedic medicine.
Male andropause, male climacteric or viropause is a condition in which men suffer from complex symptomatology due to low androgen level with aging. After the age of 40 years testosterone level starts declining and andropause corresponds to the age at which a pathogenic threshold is reached. This review summarizes the etiology, consequences, screening, diagnosis, monitoring of androgen deficiency in aging male (ADAM). The pros and cons of testosterone replacement therapy (TRT) in elderly male have been discussed. Currently oral, transdermal, transbuccal, intramuscular, and subcutaneous implants are available for clinical use. The choice is made by physicians based on therapeutic indication and patient preferences.
The effects of shilajit and the combined effects of its main constituents, fulvic acids (FAs), 4′-methoxy-6-carbomethoxybiphenyl (MCB) and 3,8-dihydroxy-dibenzo-α-pyrone (DDP), were studied in relation to the degranulation and disruption of mast cells against noxious stimuli. Shilajit and different combinations of FAs, MCB and DDP provided statistically significant protection to antigen-induced degranulation of sensitized mast cells, markedly inhibited the antigen-induced spasm of sensitized guinea-pig ileum, and prevented mast cell disruption induced by compound 48/80. The findings are appraised in view of the clinical use of shilajit in the treatment of allergic disorders in Ayurvedic medicine.
The effect of Salajeet on development of mice embryo was studied. A total of 71 pregnant female mice were given Salajeet (250 and 500 mg kg<sup>-1</sup>) orally via needle tube, daily from day 8-12 of pregnancy. All the treated and control animals showed no differences in the number of the litter size, the placenta and the body weight of the embryos and the number of resorped embryos at day 17 of gestation. However few abnormalities were observed in both treated and control groups.
Testosterone is synthesised mainly if not entirely by the leydig cells and secreted episodically with a slight circadian variation. Only the free, nonprotein-bound fraction of the testosterone in the circulation is biologically active. This free testosterone passes into the target cells and is taken up by specific receptors in the muscle. In some other target tissues, testosterone is first reduced to 5alpha-dihydrotestosterone which is then taken up by specific receptors in the cytoplasm and transferred to the nucleus. Anti-androgens appear to act principally by inhibiting this uptake.
A progressive decrease in androgen production is common in males after middle age. The resulting clinical picture has been erroneously named male menopause or andropause. A more appropriate designation is androgen decline in the aging male (ADAM). The syndrome is characterized by alterations in the physical and intellectual domains that correlate with and can be corrected by manipulation of the androgen milieu. We review the epidemiological aspects of aging and endocrinological manifestations of ADAM, and provide recommendations for treatment and monitoring of these patients. We performed MEDLINE, Pubmed, Current Contents and Pharmaceutical Abstracts searches of relevant peer reviewed publications on andropause, male climacteric, adult hypogonadism and aging. In addition, conference proceedings were researched to provide a more complete review of the literature. Information was scrutinized and collated, and contributory data were reviewed and summarized. ADAM is a clinical entity characterized biochemically by a decrease not only in serum androgen, but also in other hormones, such as growth hormone, melatonin and dehydroepiandrosterone. Clinical manifestations include fatigue, depression, decreased libido, erectile dysfunction, and alterations in mood and cognition. The onset of ADAM is unpredictable and its manifestations are subtle and variable, which has led to a paucity of interest in its diagnosis and treatment. Urological practice commonly includes a large proportion of men older than 50 years. Therefore, it is important for urologists to recognize the manifestations of and be familiar with evaluations necessary to document ADAM as well as its treatment and monitoring.