Open Journal of Urology, 2012, 2, 157-163
http://dx.doi.org/10.4236/oju.2012.223030 Published Online October 2012 (http://www.SciRP.org/journal/oju)
Clinical Evaluation of Efficacy and Safety of a Herbal
Formulation in Benign Prostatic Hyperplasia: A Single
Blind, Randomized, Placebo-Controlled Study*
Ramanathan Jeyaraman1, Pralhad S. Patki2#
1Department of Urology, Madras Medical College, Chennai, India
2The Himalaya Drug Company, Bangalore, India
Received July 4, 2012; revised August 6, 2012; accepted August 26, 2012
Benign prostatic hyperplasia (BPH) is a condition intimately related to ageing. Currently available treatment options for
the management of BPH have various limitations and associated adverse effects. A polyherbal formulation is claimed to
be beneficial in patients with benign prostatic hyperplasia. This single blind, placebo-controlled study evaluated the
clinical efficacy and safety of polyherbal formulation in BPH. Material and Methods: A total of 60 patients who were
diagnosed as BPH and who were willing to give informed consent were included in the study. At the randomization
visit, a detailed medical history was obtained and the patients underwent a thorough systemic examination and digital
rectal examination. Routine blood analysis, urinalysis and serum levels of prostate specific antigen were carried out.
Abdominal pelvic ultrasonography was done at entry and after completing the study. The severity of the urinary pa-
rameters was evaluated using American Urological Association symptom score. All the patients were randomized using
random table into either polyherbal group (n = 30) or placebo (n = 30). Each patient received either polyherbal formula-
tion or placebo in a dose of 2 capsules twice a day with meals for two months. All adverse events reported by the pa-
tients or observed by investigators were recorded. Statistical analysis was done according to the intention-to-treat prin-
ciples. Analysis was performed between the groups using Fisher’s exact test or unpaired “t” test (Independent t-test).
Results: Fifty-six patients completed the study. There was a significant improvement in the mean AUA symptom score,
PVR urine volume urinary hesitancy, intermittent flow, straining during urination, sense of incomplete micturition and
frequency of night-time urination, in the polyherbal formulation group. Four patients from the placebo group withdrew
from the study due to lack of benefit to the treatment. Conclusion: The beneficial clinical efficacy of polyherbal for-
mulation observed in this study in the management of BPH could be due to the synergistic actions of its potent herbs.
This polyherbal formulation was well tolerated and safe.
Keywords: Phytotherapy; Ayurveda; Clinical Evaluation
The prostate is about the size of a walnut in men younger
than 30 years , situated at the base of the bladder, deep
in the male pelvis, and surrounds the proximal portion of
the urethra. Prostate size increases gradually leading to
benign prostatic hyperplasia (BPH) in most men older
than 60 years . Benign prostatic hyperplasia is a non-
malignant enlargement of the prostate that is due to ex-
cessive cellular growth of both the glandular and the
stromal elements of the gland in the periurethral zone of
the prostate . BPH is nearly universal result of the
aging process in men.
The principal hypothesis for the hypertrophic reaction
of prostate tissue is steroid mediated cellular proliferation
and inflammatory response to local infection. Also inef-
ficiency of apoptotic machinery and aberrant stromal-
epithelial interactions are also suggested to probably
contribute to the abnormal growth of prostate .
As men age, the level of circulating testosterone de-
creases, while the number of androgen receptors in-
creases, causing the overgrowth of the prostate . The
result is an enlarged prostate gland that causes bladder
outflow obstruction. Because the enlarged gland ob-
structs the prostatic urethra, the patient strains during
urination to overcome the obstruction. Over time, strain-
ing to urinate causes the detrusor muscle of the bladder
to thicken and diverticula to form in the bladder. When
the detrusor muscle can no longer generate sufficient
*Financial support: The Himalaya Drug Company, Makali, Bangalore-
562 123 (India).
opyright © 2012 SciRes. OJU
R. JEYARAMAN, P. S. PATKI
pressure to overcome the urethral obstruction, the blad-
der fails and retains urine. Destruction of striated and
smooth muscles results in urinary incontinence .
Symptoms of BPH can be either irritative or obstruc-
tive. Obstructive symptoms include straining, hesitancy,
weak stream, intermittency, and sense of incomplete
bladder emptying and irritative symptoms include ur-
gency, frequency, and nocturia .
Based on the American Urological Association (AUA)
symptom score prostate can be classified as mild, moder-
ate and severe. Symptoms are measured on a scale of 1 to
35. A score of 1 to 7 is classified as mild symptoms, 8 to
19 signify moderate symptoms, and a score from 20 to 35
signifies severe symptoms .
The AUA recommends routine urinalysis for the di-
agnosis of BPH. Urinalysis can reveal pyuria and bacte-
riuria suggesting infection, hematuria suggesting inflam-
mation or urothelial malignancy, or active urinary sedi-
ment suggesting postobstructive nephropathy. Optional
studies include serum creatinine and prostate specific
antigen (PSA) . The PSA is a strong predictor of
prostate volume in BPH  and level increases at ad-
vanced stage of the disease and helpful in monitoring at
later stage for clinical management .
Although most of the patients seek medical care for
the symptoms of BPH, urinary tract obstruction due to
longstanding BPH can cause some major health problems
such as bleeding from the prostate, recurrent infections,
bladder stones, inability to urinate, and renal insuffi-
The goal of therapy is to reduce or alleviate lower uri-
nary tract symptoms, to prevent complications, and to
minimize the adverse effects of treatment . Watchful
waiting is the preferred management strategy for patients
with mild symptoms and also an appropriate option for
men with moderate to severe symptoms who have not yet
developed complications of BPH.
Currently available drugs for treatment of BPH are
α1-adrenergic antagonists (tamsulosin, alfuzosin, doxa-
zosin and terazosin) and 5α-reductase inhibitors (finas-
teride and dutasteride). These medications act on dy-
namic and static components of bladder outlet obstruc-
tion [13,14]. α1-Adrenergic antagonists act on the dy-
namic component of bladder outlet obstruction are the
initial choice of medical treatment in most men with
BPH. In men with large prostate glands (>40 mL), higher
PSA levels, and moderate to severe symptoms, treatment
with 5α-reductase inhibitors or combination therapy is
Open surgical removal of prostatic adenoma remained
the gold standard treatment of BPH for many decades.
The conversion from open to transurethral surgery oc-
curred gradually . Minimally invasive procedures are
performed in more advanced degrees of outlet obstruc-
tion. In patients in whom medical and minimally invasive
options for BPH have been unsuccessful, more invasive
treatment are considered like transurethral resection of
the prostate (TURP).
Both selective and less-selective α-blockers may be
associated with dizziness, asthenia, and postural hypoten-
sion, limiting therapy. Decreased libido and impotence
are more common in men taking finasteride . Al-
though, transurethral resection is an effective treatment
for symptomatic BPH, approximately 15% to 25% of pa-
tients who undergo surgery do not have satisfactory long-
term outcomes . Because of these problems and the
desire of patients to avoid surgery whenever possible,
there has been much interest in alternative treatments. In
the present study, a polyherbal formulation is evaluated
for its efficacy and safety. Good agricultural and collec-
tion practice (GACP) was followed during the collection
and manufacture of this Ayurvedic formulation. Botani-
cal identification and desired quality were in accordance
with the guidelines of Pharmacopoeial Standards of an
Ayurvedic formulations and were carried out by a quail-
fied chemist approved by the Food and Drug Administra-
tion. The formulation was finalised by a team of Ay-
urvedic Scientists after scanning Ayurvedic and contem-
porary scientific literatures. This formulation has been
approved by regulatory authorities in India as an Ay-
urvedic formulation and is available for clinical practice.
The principal herbs of this polyherbal formulation in-
clude extracts of Curculigo orchioides, Lactuca scariola,
Asteracantha longifolia, Mucuna pruriens, Parmelia per-
lata, Argyreia speciosa, Tribulus terrestris and Leptade-
nia reticulat (Table 1). The stability of this formulation
was tested by accelerated study (upto 6 months) and real
time study (upto 3 years).
Table 1. Composition of polyherbal formulation: each
Plant Name Quantity
) 32 mg
Vanya kahu (
) 8 mg
) 16 mg
) 20 mg
) 32 mg
) 64 mg
) 64 mg
) 64 mg
Herbs in the above formula are cleaned and reduced to a coarse powder in a
pulverizer individually and blended in the ratio mentioned above. This herbal
blend is extracted with demineralized water, filtered and concentrated. The
extract is then granulated and reduced to required mesh size, blended and filled
Copyright © 2012 SciRes. OJU
R. JEYARAMAN, P. S. PATKI 159
2. Aim of the Study
This study was planned to evaluate the clinical efficacy
and safety of a polyherbal formulation in the manage-
ment of benign prostatic hyperplasia.
3. Materials and Methods
3.1. Study Design
This was a single blind, randomized and placebo-con-
trolled clinical study conducted at Bharathi Raja Multis-
peciality Hospital, Chennai, India, as per WHO opera-
tional guidance to support clinical trials of herbal product
. Patients were unaware of the treatment assigned to
them. The study protocol, case report forms, regulatory
clearance documents, product related information and
informed consent form were submitted to the “Institut-
ional Ethics Committee” and were approved by the same.
3.2. Sample Size Calculation
Sample size was calculated based on the Nomogram for
standardized difference of 0.83 with 90% power to detect
the difference with a two-tailed p value of 0.05 . Bas-
ed on this calculation, the sample size is approximately
58: i.e., 29 participants required for each arm of the study.
The total sample size for this study was rounded off to 60
Sixty patients were randomized into two groups of 30 in
each of placebo and drug group. Randomization was car-
ried out by sequential opening of sealed opaque enve-
lopes (prepared by Dr. PS Patki) containing the random
group allocation previously generated using random table
and opened in numerical order as the subject entered the
study by the chief investigator (Dr. R. Jeyaraman). Pa-
tients were free to withdraw from the study, if they so de-
sired, without assigning any reason. Effectiveness of sin-
gle blinding was checked by the chief investigator by
questioning the patients during the course of the clinical
3.4. Inclusion Criteria
A total of 60 patients, aged between 30 and 65 years,
who were diagnosed as suffering from BPH and who were
willing to give informed consent were included in the
study. The patients were categorized by the “AUA sym-
ptom score index” as either mild (0 - 7 points), moderate
(8 - 19 points) or severe (20 - 35 points) cases of BPH.
3.5. Exclusion Criteria
Patients with diabetes mellitus, prostatic carcinoma, pro-
statitis, carcinoma bladder, neurogenic bladder, stricture
urethra, vesical calculus and those patients who were not
willing to give informed consent were excluded from the
study. Similarly patients with raised prostate surface an-
tigen (≥3.9 ng/ml) were excluded from the study.
3.6. Study Procedure
At the initial randomization visit, a detailed medical his-
tory, with special emphasis on history of urinary symp-
toms (hesitancy, straining, intermittency, frequency, noc-
turia, poor flow and sensation of incomplete voiding)
was obtained from all the patients. All the patients un-
derwent a thorough systemic examination and digital
rectal examination (DRE). Routine blood analysis, uri-
nalysis and serum levels of PSA were done for all the
patients. In addition, abdominal pelvic ultrasonography
was done at entry and after completing the study to esti-
mate the approximate prostate weight and size and to
measure the post-void residual (PVR) volume. The se-
verity of the urinary parameters was evaluated using
AUA symptom score. All the patients were randomized
arbitrarily using random table into either polyherbal
group (n = 30) or placebo (n = 30). Each patient received
either a polyherbal formulation or placebo in a dose of 2
capsules, twice a day with meals for two months. The
outcome of each group was assessed by comparing uri-
nary hesitancy, intermittency, straining during micturi-
tion, urine flow, sense of incomplete micturition, fre-
quency of nocturnal micturition, AUA symptom scores
and PVR volume.
3.7. Primary and Secondary Endpoints
The predefined primary efficacy endpoints were, evalua-
tion of AUA score, PVR urine, urinary flow rate and qua-
lity of life. The predefined secondary safety endpoints
were evaluation of clinical and biochemical safety pro-
Patients underwent the same evaluations after treatment
as were performed at baseline, regardless of their treat-
ment received and outcome. Compliance to drug therapy
was evaluated by asking the patients to return back the
investigational product container and counting the num-
ber of the remaining capsules.
3.9. Adverse Events
All adverse events, either reported or observed by pa-
tients, were recorded with information about severity,
date of onset, duration, and action taken regarding the
study drug. Relation of adverse events to the study medi-
cation was predefined as “Unrelated” (follows a reason-
able temporal sequence from the administration of the
Copyright © 2012 SciRes. OJU
R. JEYARAMAN, P. S. PATKI
Copyright © 2012 SciRes. OJU
drug), “Possible” (follows a known response pattern to
the suspected drug, but could have been produced by the
patient’s clinical state or other modes of therapy admin-
istered to the patient), and “Probable” (follows a known
response pattern to the suspected drug that could not be
reasonably explained by the known characteristics of the
patient’s clinical state).
Patients were allowed to voluntarily withdraw from
the study, if they so desired without assigning reasons.
For patients withdrawing from the study, efforts were
made to ascertain the reason for dropout. Non compli-
ance (defined as failure to take less than 80% of the
medication) was not regarded as treatment failure, and
reasons for non compliance were noted.
3.10. Statistical Analysis
Statistical analysis was done according to the intention-
to-treat principles using GraphPad Prism version 4.03,
for windows (GraphPad software, San Diego, California
USA). The analysis included all randomized subjects in
the groups to which they were allocated and the missing
responses was evaluated using the last observation carry
forward method (LOCF). Changes in various parameters
were assessed for statistical evaluation using between the
group analysis at entry and at the end of the study.
Fisher’s exact test was used for urinary symptoms and
unpaired “t” test (Independent t-test) for AUA symptom
score, prostate weight and postvoid residual volume.
Minimum level of significance was fixed at 95% confi-
dence limit and two-sided p < 0.05 was considered sig-
Sixty consecutive patients were enrolled into the trial
between December 2007 and March 2009 were randomly
divided into two groups of 30 each. Mean age was 47.00
± 10.80 years in polyherbal group and 50.30 ± 6.50 years
in placebo group. In polyherbal formulation group, 12
patients were smokers, 6 were alcoholics and 17 patients
were vegetarians. In placebo group, 11 patients were
smokers, 8 were alcoholics and 22 patients were vege-
tarians. There was no statistical difference between the
polyherbal formulation and placebo groups (Table 2).
Data of the 56 patients was available for analysis as
four patients from the placebo group withdrew from the
study due to lack of benefit to the treatment (the missing
responses were evaluated using the LOCF method). The
baseline values (on entry) for various parameters in the
placebo and polyherbal treatment groups were not sig-
nificant. There was significant reduction in the presence
of urinary hesitancy in the polyherbal treatment group
(8/19 patients) as compared to placebo (14/17 patients)
(p < 0.01) at the end of treatment and reduction in inter-
mittent urinary flow in the polyherbal treatment group
(7/16 patients) as compared to placebo (19/21 patients)
(p < 0.003). Polyherbal treatment group showed signifi-
cant improvement in parameters such as straining during
urination (p < 0.001), poor flow (p < 0.005) and sense of
incomplete micturition (p < 0.02) as compared to the
placebo group (Table 3).
Table 2. Demographic data of patients on entry (n = 60).
No. of patients on entry 30 30
No. of patients withdrawn 0 4
Mean age (years) (Mean ± SD)47.00 ± 10.80 50.30 ± 6.50
Smokers (No. of patients) 12
Alcohol (No. of patients) 6
Diet (veg.) 17
Table 3. Effect of polyherbal formulation and placebo on urinary symptoms in patients with BPH.
No. of patients showing symptoms
No. of patients showing symptoms at the
end of treatment
Polyherbal formulation Placebo
Hesitancy of urination 19 17 NS 08 14 0.01
Intermittent flow 16 21 NS 07 19 0.003
Straining during urination 26 22 NS 19 22 0.0001
Poor flow 17 15 NS 06 13 0.005
Sense of incomplete micturition 24 20 NS 13 18 0.02
Nocturia 23 25 NS 14 22 0.013
NS: Not significant; Statistical analysis: Fisher’s exact test.
R. JEYARAMAN, P. S. PATKI 161
In polyherbal formulation group, nocturia (frequency
of night-time urination) was significantly reduced in com-
parison to placebo group (Table 3, p < 0.013).
AUA symptom score and PVR volume showed sig-
nificant reductions in the polyherbal treatment group as
compared to placebo at the end of treatment (p < 0.0001).
Also prostate weight was reduced after treatment with
polyherbal formulation as compared to placebo, though it
was not statistically significant (Table 4).
Assessment of questionnaires revealed an improve-
ment in the QOL observed in Prostacare group as com-
pared to placebo group. This was further supported by
the findings which included AUA score, frequency of
urination and nocturia (Tables 3 and 4).
No adverse effects were reported with polyherbal for-
mulation during the entire study period except slight to
notable hot flushes reported by 2 patients during poly-
herbal formulation therapy, which subsided at the end of
the study period and did not necessitate the withdrawal of
the polyherbal formulation.
Benign prostatic hyperplasia refers to an anatomic diag-
nosis, in practice it is typically diagnosed clinically on
the basis of lower urinary tract symptoms and prostatic
enlargement detected on manual rectal examination or
transrectal ultrasonograph . Blocking androgen re-
ceptor activity is a common therapeutic course for BPH
. This approach however, results in several side ef-
fects, and most notably erectile dysfunction [23,24]. The
risks and complications associated with TURP include
post-operative hemorrhage, TUR-syndrome, urinary tract
infection, retrograde ejaculation, bladder neck contrac-
tures and urethral strictures.
In the present study, polyherbal formulation was
evaluated for the beneficial actions on the prostate. Cur-
culigo orchioides is effective mainly on the urinary sys-
tem and it is given in dysuria, and in poluria. It has
5α-reductase inhibitor activity that helps to manage
prostatic enlargement . Lactuca scariola exhibits
antibacterial activity that may be helpful in preventing
the chronic urinary infection as seen in BPH . As-
teracantha longifolia has antimicrobial activity that may
be helpful in infections caused due to stasis of urination
along with infection in the hyperplasic prostatic mass in
Mucuna pruriens roots are used for diseases of renal
and prostatic affections . It also possesses anti-in-
flammatory activity that may be helpful in providing
symptomatic relief in BPH . On administration of
Mucuna pruriens extract improvement in serum creatin-
ine and urea, showing potent nephroprotective activity
have been observed . Parmellia perlata is active
against common pathogens . It contain acidic sub-
stance that has been used as an antimicrobial agent espe-
cially against Salmonella aureus that is implicated in
mixed infections and has shown high level of resistance
to the commonly marketed antibiotics. This activity
stands may be helpful in providing symptomatic relief
from symptoms of infections in prostatic mass, urinary
bladder, and kidney due to susceptible organism .
Argyreia speciosa root has diuretic and aphrodisiac
activities. Also it is effective in infection caused by
common pathogens due to its antimicrobial activity and
may be beneficial in management of BPH . A. spe-
ciosa possesses anti-inflammatory activity and support
the rationale behind the traditional use of these plants in
inflammatory conditions and may be useful in BPH .
Tribulus terrestris exerts strong anti-inflammatory ac-
tivity, and provide beneficial effect in BPH . The
fruits are regarded as diuretic, tonic, and are used in
painful micturition, calculus affections, and urinary dis-
orders . Serum luteinizing hormone may play a role
in control of luteinizing hormone (LH) as in some inves-
tigation, it is found with low LH in cases of BPH .
Tribulus terrestris shows potential increase in LH and
may play role in controlling prostatic hyperplasia in BPH
. Leptadenia reticulata herb is used as stimulant and
restorative. It is also used in dysuria, which may be
helpful in BPH [39,40]. This herb has bacteriocidal acti-
vity and used in inflammatory conditions of prostate
Herbal formulations like Saw Palmetto blend have
been used to evaluate their safety and efficacy . An
Table 4. Effect of polyherbal formulation and placebo on AUA symptom score, ultrasonography and uroflowmetry
On entry At the end of treatment
Polyherbal formulation Placebo
AUA symptom score 14.60 ± 3.20 13.80 ± 4.60NS 9.2 ± 2.60 12.90 ± 3.800.0001
Prostate weight (gms) 34.60 ± 8.70 32.60 ± 8.30NS 32.60 ± 9.40 34.50 ± 6.60NS
Post-void residual (PVR) volume (ml)85.30 ± 20.20 86.20 ± 18.20NS 52.10 ± 23.10 89.70 ± 28.300.0001
NS: Not significant; Values are indicated in Mean ± SD; Statistical analysis: unpaired “t” test (independent t-test).
Copyright © 2012 SciRes. OJU
R. JEYARAMAN, P. S. PATKI
analysis has also been carried out to evaluate costs of
alternate treatments for benign prostate hypertrophy .
Herbal therapy has been a favored therapy for their
The beneficial actions observed in this study in the
management of BPH could be due to the synergistic ac-
tions of the potent herbs of polyherbal formulation which
include 5α-reductase inhibitor activity of Curculigo or-
chioides, bacteriocidal and antimicrobial activity of Lac-
tuca scariola, Asteracantha longifolia, Argyreia speciosa
and Parmellia perlata, anti-inflammatory activity of
Mucuna prurien, Argyreia speciosa, Tribulus terrestris
and Leptadenia reticulata, LH enhancing activity of
Tribulus terrestris and nephroprotective activity of Mu-
The study outcome was found to be beneficial in the
management of moderate BPH, however, it has some
limitations, like a need for larger multicentric trials to
further confirm these findings.
This study was planned to evaluate the clinical efficacy
and safety of polyherbal formulation in BPH. Present
study observed a significant reduction in the mean AUA
symptom score, PVR volume and significant reduction in
urinary hesitancy, intermittent flow, straining during uri-
nation, poor flow, sense of incomplete micturition and
frequency of night-time urination, in the polyherbal for-
mulation group, which indicate clinically beneficial ef-
fects of polyherbal formulation in BPH. Polyherbal for-
mulation was well tolerated and safe. The beneficial
clinical efficacy of polyherbal formulation in the man-
agement of BPH could be due to the synergistic actions
of its potent herbs. Therefore, it may be concluded that
use of polyherbal formulation is clinically effective and
safe in the management of BPH. However, a larger study
is needed to confirm these findings. We also warn that
raised PSA levels need to be ruled out before starting this
Authors thank Dr. Rangesh Paramesh. MD (Ayur) for his
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