A Clinical Review on a Polyherbal Formulation, Renalka revIew artICle

review article
A Clinical Review on a Polyherbal Formulation, Renalka
Syrup in Urinary Tract Infection
MG Desai*, D Palaniyamma**
Abstract
Urinary tract infections (UTIs) are common bacterial infections in general practice and are responsible for considerable morbidity
in certain groups. UTI can be defined as a condition wherein bacteria multiply within the urinary tract. Numerous antimicrobial
agents are used to treat UTIs with mixed clinical response. Recurrent UTI, despite antimicrobial treatment is a cause of clinical
concern due to their adverse effects on long-term and also because of rising incidence of drug resistance. Hence alternative
agents, other than antimicrobial drugs, that are beneficial in treating UTI are required. Recently, there has been emphasis on the
search for herbal preparations that can be helpful in the management of urinary disorders. In the Indian medical literature, many
drugs have been advocated for this indication. Renalka syrup is a well-balanced, multi-ingredient formula with proven value
in a variety of urinary disorders. It is a natural and effective alkalizer. The potent herbs possess analgesic, anti-inflammatory
and diuretic activity without increasing excretion of electrolytes such as sodium, chloride and bicarbonate. Renalka syrup not
only relieves burning micturition, but also soothes inflamed urinary mucosa. It restores normal urinary pH and normalizes
the frequency of micturition. It is effective for long-term prophylaxis of UTI. Several clinical trials were conducted to evaluate the
efficacy of this herbal urinary alkalizer in bacteriologically-proven UTIs. It was found to be safe and effective in relieving
the symptoms of UTI. Five clinical studies conducted with Renalka syrup on substantial sample size are discussed in the review.
Keywords: Renalka, urinary tract infection, alkalizer
U
rinary tract infections (UTIs) are among the
most prevalent microbial diseases and their
financial burden on society is substantial.
These accounted for nearly seven million office visits
and one million emergency department visits, resulting
in 1,00,000 hospitalizations in the US.1
UTI refers to the presence of microbial pathogens
within the urinary tract. Usually classified by the site of
infection (bladder [cystitis], kidney [pyelonephritis] or
urine [bacteriuria]), these can also be asymptomatic
or symptomatic, characterized by a wide-spectrum of
symptoms ranging from mild irritative voiding to
bacteremia, sepsis or even death. UTIs that occur
in a normal genitourinary tract with no prior
instrumentation are termed ‘uncomplicated’ (uUTI),
whereas infections that are associated with structural
or functional abnormalities, including instrumentation
*Associate Professor, Dept. of Urology
Dr BR Ambedkar Medical College and Hospital, Bangalore
**Medical Advisor
R&D Center, The Himalaya Drug Company, Makali, Bangalore
Address for correspondence
Dr D Palaniyamma
Medical Advisor
R&D Center, The Himalaya Drug Company
Makali, Bangalore - 562 123
E-mail: [email protected]
such as indwelling urethral catheters, and are frequently
asymptomatic are termed ‘complicated’ (cUTI).2,3
The main causative pathogen involved in recurrent
UTI in women is Escherichia coli, which accounts for
about 80% of all episodes. Other significant pathogens
include Staphylococcus saprophyticus, Klebsiella pneumoniae
and Proteus mirabilis; each causes about 4% of all
episodes of acute cystitis. Citrobacter and Enterococci
are less likely causes of UTI in women.4
In the classic theory for UTI development, the
uropathogen is a part of the fecal flora. It colonizes
the vagina and distal urethra. It then ascends into the
bladder and causes infection. This model is the same
for sporadic and for recurrent UTI in women.5,6
Reservoirs of uropathogenic bacteria can remain in
the gastrointestinal tract and vagina of the susceptible
individual.
Diagnosis and management can be done based
on symptoms alone without further laboratory
confirmation. In complicated or questionable cases,
urinalysis is done to confirm the diagnosis and to detect
presence of urinary nitrites, red blood cells (RBCs), white
blood cells (leukocytes), leukocyte esterase or bacteria.
Urine culture is deemed positive, if it shows a bacterial
colony count of ≥103 colony-forming units (CFU)/ml.
Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
11
review article
Antibiotic sensitivity can also be tested, by carrying
out urine culture and sensitivity test which will be
useful in the selection of antibiotic treatment.7
UTI is the second most common clinical indication
for empirical antimicrobial treatment in primary and
secondary care, and urine samples constitute the largest
single category of specimens examined in most medical
microbiology laboratories.8
Antibiotics such as fluoroquinolones (norfloxacin,
ciprofloxacin, pefloxacin), cephalosporins (cephalexin,
cefaclor), trimethoprim-sulfamethoxazole and nitrofurantoin are commonly used. Choice of antibiotic
should rely on community patterns of resistance,
adverse events and local costs. Antibiotics are usually
effective in treating acute infections and are the primary
means of prophylaxis for recurrent UTI patients; but,
their utility is declining by the emergence of increasing
numbers of drug-resistant bacteria.9 At least 50% of
men with recurrent UTI10 and over 90% of men with
febrile UTI11 have prostate involvement, which may
lead to complications such as prostatic abscess or
chronic bacterial prostatitis.
Each system of the body has its own physiological
pH value and variation too far from that pH range,
increases susceptibility to disease. Humans live in
an acidic environment with poor quality and highly
processed foods, polluted water and air, environmental
toxins, poor breathing techniques and acidifying
prescription medications consistently adding to the
acidic burden of the body. Most diseases arise from
an acidic milieu. An acidic body is a reactive body,
thus by reducing acidity, one can also reduce allergic
symptoms, tendency towards inflammation and
reverse the trend towards chronic conditions. An
alkalizer helps to reduce tissue acidosis and shift
the acid-base balance to a normal range, promoting
good health and well-being. Dysuria is attributed to
the acidic urine, due to bacterial infection. Therefore,
alkalinization of the urine may provide symptomatic
relief.12
Recently, there has been greater emphasis on the
search for herbal preparations that can be help in
the management of urinary disorders. In the Indian
medical literature, many drugs have been advocated
for this indication. Renalka syrup is a well-balanced,
multi-ingredient formula with proven value in a
variety of urinary disorders. It is a natural and effective
alkalizer, not only relieves burning micturition, but also
soothes inflamed urinary mucosa. It restores normal
urinary pH and normalizes the frequency of
micturition. It is effective for long-term prophylaxis
12
Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
of UTI. In this review, we discuss five clinical studies
conducted with Renalka syrup.
Pharmacological actions of individual
herbs in Renalka Syrup
Renalka syrup contains principal ingredients like
Gokshura (Tribulus terrestris), Varuna (Crataeva magna),
Sariva (Hemidesmus indicus), Musta (Cyperus rotundus),
Ushira (Vetiveria zizanioides), Shatavari (Asparagus
racemosus), Trikatu, Ela (Elettaria cardamomum) and
Kshara parpati.
Gokshura or (T. terrestris): It has remarkable antiinflammatory and analgesic actions to reduce pain, as
noticed during dysuria. The anti-inflammatory action
normalizes the mucosa.13 It also has antimicrobial
actions against common etiopathogens.14 T. terrestris
has potent diuretic action that increases blood flow
in the kidneys.15 This, in turn, increases glomerular
filtration rate (GFR), and hence urinary output. Though
it increases the excretion of water, it does not increase
elimination of electrolytes such as sodium, chloride
and bicarbonate as occurs with other diuretics. This
action is useful in conditions such as pyelonephritis,
urethritis and cystitis and also prevents urolithiasis
that result from stasis of the urine in kidneys. It is
renoprotective by increasing chloride and creatinine
clearance from the body.15
Varuna (C. magna): It has remarkable anti-inflammatory
and analgesic actions to reduce pain on urination
(dysuria). The anti-inflammatory action normalizes
the mucosa.16 It is useful in urolithiasis and other
disorders of the urinary tract.17
Sariva (H. indicus): It is renoprotective against
chemically-induced nephrotoxicity.18 The potent
antioxidants in the herb protect the genitourinary
system from oxidative tissue damage.19,20 Due to its
probably alterative and urinary supportive actions, it
normalize urinary pH.21
Musta (C. rotundus): The anti-inflammatory and
analgesic actions reduce pain of dysuria.22 C. rotundus
has potent diuretic action that increases blood flow in
the kidneys. This, in turn, increases GFR and hence
the urine output.23
Ushira (V. zizanioides): The potent diuretic action of
this herb increases GFR and the urine output.
This process increases the amount of water excreted,
but does not increase elimination of electrolytes such as
sodium, chloride and bicarbonate as occurs with other
diuretics.24
review article
Shatavari (A. racemosus): It has antimicrobial
against common etiopathogens involved in
It also has inhibits lithiasis and reduces the
of stones.26 The antioxidants in the herb
the genitourinary system from oxidative
damage.27,28
actions
UTIs.25
weight
protect
tissue
Trikatu: An Ayurvedic formulation comprises a 1:1:1
ratio of dried fruits of Piper nigrum, P. longum and
dried rhizomes of Zingiber officinale. Piperine from
P. nigrum is rapidly absorbed across the intestinal
barrier, and acts as an apolar molecule forming apolar
complex with drugs and solutes. This modulates
membrane dynamics, due to its easy partitioning thus
increasing permeability across the barriers. These
membrane modulations enhance bioavailability of
nutrients and medications.29
Ela (E. cardamomum): It has remarkable antiinflammatory and analgesic actions to reduce pain, as
noticed during dysuria. The anti-inflammatory action
normalizes the mucosa.30
Kshara parpati: Its potent diuretic action increases
blood flow in the kidneys, which increases GFR and
hence the output of urine. Though water excretion
is increased, but excretion of electrolytes (sodium,
chloride and bicarbonate) is not increased. The
urinary pH is normalized possibly due to alterative
and urinary supportive actions.31
Clinical studies
Study 1: Clinical Trial on Renalka Syrup in UTI32
Material and methods: Fifty patients (23 males and
27 females) aged 17-65 years with a history of burning
micturition, increased frequency of urination, fever,
hematuria and pyuria were enrolled in the study
(Table 1). UTI was diagnosed on the basis of clinical
features and examination. Written informed consent
was obtained from each patient. The study subjects
were administered Renalka syrup at a dose of two
teaspoonfuls twice-daily for 2-4 weeks. They were
followed-up at regular intervals to evaluate its effect
and also to rule out any side effects. The response
to the drug (Renalka syrup) was observed by urine
examination and culture, total leukocyte count (TLC)
and differential leukocyte count (DLC). The results
were assessed based on patients’ response as very good,
good and poor. Results: Of the 36 patients diagnosed
with cystitis, 18 patients (50%) improved within a week,
10 (28%) responded well after two weeks of treatment
and two patients (5%) showed response after 3 weeks
of treatment. But, only six patients (17%) required
adjuvant oral antibiotics before they responded
(Table 2). No patient developed any side effects that
would have required either reduction in the dose or
omission of the drug. No patients withdrew from the
trial. Conclusion: Renalka syrup is effective in the
treatment of cystitis and chronic prostatitis, without
producing any undesirable side effects. In chronic UTIs,
it may be useful for long-term prophylaxis. However, a
larger clinical trial is proposed to evaluate its efficacy in
a wider perspective.
Study 2: UTI and Its Management by Renalka33
Material and methods: The present clinical trial was
carried out in 30 female patients in the age group of
22-46 years, attending Prasuti Tantra OPD of SS
Hospital, Institute of Medical Sciences, Banaras
Hindu University, Varanasi. A complete history of the
patients was recorded in a specially prepared research
proforma and patients were registered in the trial
with an informed consent for the given treatment.
Urine analysis and culture was done in all the cases
before starting the clinical trial. Renalka syrup was
Table 1. Symptom-wise Grouping of Patients32
Symptom
No. of patients
Cystitis
36
Prostatitis
10
Prostatic abscess
1
Pyelonephritis
3
Table 2. Response to Treatment with Renalka Syrup32
Indication
1 week
Response to treatment with Renalka syrup
2 weeks
3 weeks
Adjuvant therapy
(oral antibiotics)
Cystitis (36)
18
10
2
6
Chronic prostatitis (10)
–
2
6
2
Prostatic abscess (1)
–
–
–
1
Pyelonephritis (3)
–
1
–
2
Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
13
review article
given twice-daily as 2 teaspoonfuls for four weeks.
Weekly urine analysis was done and clinical findings
were recorded. Urine culture was treated at the end of
four weeks treatment. The final assessment of results
was done at the end of four weeks. Twenty-six patients
complained of burning micturition, 21 had frequency
of urination, 12 patients had severe dysuria with
mild-to-moderate fever and 12 only had dysuria as a
presenting symptom. Renalka syrup was given twicedaily as 2 teaspoonfuls for four weeks.Urine culture was
done in all 30 patients prior to treatment. The culture
was positive in 90%. Results were assessed based on
patients’ response as very good, good and poor. Urine
analysis revealed the presence of albumin in 20 patients,
pus cells in 23 patients, epithelial cells in 19 patients
and RBCs in five patients. Results: There was marked
relief in burning micturition (96.15%) and frequency
of micturition (95.23%). Eleven out of 12 patients
showed relief in dysuria with mild fever (91.66%),
whereas all the patients had complete relief of dysuria
(Table 3). Renalka syrup was also found to be effective
against pathogens like E. coli, B. proteus, Klebsiella and
Pseudomonas (Table 4). No side effects, which would
have required a dose reduction or omission of the drug,
were reported. No patients withdrew from the trial.
Conclusion: Renalka, an Ayurvedic preparation has
proved its efficacy and safety in chronic UTI. The trial
drug was quite effective in controlling and relieving
clinical symptoms significantly.
Study 3: Renalka Syrup in the Treatment of
UTI34
Material and methods: All patients included in the
study were subjected to a detailed clinical examination,
urinalysis, urine culture, hemoglobin (Hb), TLC, DLC,
urea, creatinine and blood glucose estimation, including
ultrasonography/X-ray KUB. Prostate was examined
in patients aged 60 or above. Paracetamol was used
if fever was >101°F. Antibiotics were withdrawn in all
patients included in this study. Renalka syrup was given
orally at a dose of two teaspoonfuls, twice-daily before
breakfast and after dinner for 2-4 weeks depending
upon clinical response. Treatment efficacy was assessed
weekly using clinical/or bacteriological criteria. Patients
with cUTI not responding to Renalka syrup in a week’s
time were given suitable antibiotics depending upon
urinary pathogens and their sensitivity pattern. The
factors responsible for cUTI were noted in each patient.
Results: Twenty-eight (70%) patients showed good
clinical response to Renalka; three patients were lost for
follow-up (Table 4). Most patients were given the drug
for two weeks and three cases continued treatment
for 4 weeks. None of the patients developed any side
effects, which would have required a reduction of the
dose or omission of the drug. Three patients withdrew
from the trial. Conclusion: Renalka syrup is an effective
herbal formulation in treatment of uUTI. Patients with
cUTI who do not respond well with Renalka alone
need antimicrobial agents. Thus, Renalka syrup is an
economical, safe and effective herbal preparation in the
management of uUTI in adults.
Study 4: Effect of Renalka Syrup in UTI35
Material and methods: Forty patients of either
sex, of different age groups with complaints like
difficulty in micturition, burning micturition, etc.,
Table 3. Clinical Response after 4 Weeks33
Symptoms
No. of patients
Relief
No.
%
Burning micturition
26
25
96.15
Frequency of micturition
21
20
95.23
Dysuria with mild fever
12
11
91.66
Dysuria alone
12
12
100
Table 4. Effect of Renalka on the Pathogens33
Organism
Culture positive before treatment
Culture negative after treatment
No.
%
E. coli
21
19
90.47
B. proteus
3
3
100
Klebsiella
2
2
100
Pseudomonas
1
1
100
14
Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
review article
from the OPD of the Dept. of Shalya Shalakya, SS
Hospital, Institute of Medical Sciences, Banaras
Hindu University, Varanasi, were enrolled in the
study. Complete clinical examinations, hematological
investigations like TLC, DLC, Hb, blood urea, serum
creatinine, urine examination (routine and microscopic
and culture and sensitivity) and ultrasonography
for urine bladder, kidney and prostate were done on
each patient. Subjects with malignancy, pregnancy,
renal failure, cerebrovascular episodes, nonconcomitant
severe illness necessitating other treatment modes,
AIDS, congenital deformity and tuberculosis, were
excluded. Antibiotic and alkalizing drugs, which are
commonly used in UTI, were withdrawn. Renalka
syrup was given at a dose of 2 teaspoonfuls, thricedaily before meals for four weeks. Patients were
assessed weekly on the basis of their symptoms and
clinical findings. All laboratory investigations were also
repeated every week. Results: Patients, who presented
with various symptoms of UTIs, were categorized
into two major groups, having indwelling catheters
21 cases (52.5%), or without indwelling catheters,
19 (47%). TLC, DLC, Hb, blood urea and serum
creatinine were routinely done before, during and
at end of therapy and no significant changes were
observed after treatment with Renalka syrup. None
of the patients developed any side effects, which
would have required a reduction of the dose or
omission of the drug. No patients withdrew from the
trial. Conclusion: Renalka syrup can be safely used
effective control of symptoms like burning micturition
and frequency of micturition in UTI. It is also
effective in eradicating common urinary etiopathogens
like E. coli.
Study 5: Renalka in UTI in Traumatic Paraplegia
Patients36
Material and methods: One hundred patients of
either sex aged between 20-60 years were included in
the trial. They were divided into two groups: Group I
included 62 patients with significant bacteriuria with
symptoms of increased frequency, dysuria, fever or
fever with chills and rigor; Group II, which included
38 patients who were asymptomatic but had significant
bacteriuria. Patients with history of malignancy, renal
failure and a nonconcomitant severe illness necessitating
other treatment modes were excluded from the study.
Baseline complete urine examination with culture and
sensitivity was done. In Group I, 32 patients (51.61%)
were on Renalka syrup and 30 (48.38%) were on
placebo. In Group II, 21 (55%) were on Renalka syrup
and 17 (45%) were on placebo. Renalka syrup was
administered at a dose of two teaspoonfuls twice-daily
before breakfast and dinner. Specific antibiotics as per
culture sensitivity report were added to the Renalka
syrup group and to the placebo group besides the drug
and placebo. Follow-up was done every 2 weeks for
six weeks. Urine routine and culture was also done at
these visits. Results: Out of 32 patients in the Renalka
group, eight patients had acidic urine at admission.
At the end of treatment, only one showed acidic urine.
In the placebo group, 21 patients had acidic urine and
at the end of six weeks, 22 cases persisted to show
acidic urine. None of these patients showed alkaline
urine pH after six weeks in placebo group. Out of
19% (4 cases) passing acidic urine at admission, only
4.76% (one) was acidic at six weeks in the Renalka and
in almost all the cases (95.24%), urine was alkaline at
six weeks. In the patients in Renalka group, urine
culture showed E. coli as the commonest pathogen (16)
followed by Klebsiella (9), Proteus (2) and five patients
culture did not reveal any organism on admission to
the study. Patients on the placebo showed the following
pathogens E. coli (15), Klebsiella (8), Proteus (2) and
urine of five patients was sterile at the beginning of
the study. At the end of six weeks 22 patients (68.75%)
the urine became sterile in the Renalka group, whereas
only nine patients (30%) were sterile in placebo group.
None of the patients developed any side effects,
which would have required a reduction of the dose or
omission of the drug. No patients withdrew from the
trial. Conclusion: Renalka syrup was found to be very
effective in symptomatic improvement of UTI within
two weeks in terms of dysuria, frequency, fever and
fever with chills and rigor as well as changing urinary
pH to alkaline medium. It was effective in preventing
UTI recurrence. It also has antibacterial activity as
evident by the decrease in bacterial colony count and
absence of pus cells in the urine. No side effects were seen
with drug or placebo. There was good response in terms
of compliance.
CONCLUSION
UTI is a common disorder in all age groups and in
both sexes worldwide. Though several antibiotics
are available for treatment, the problem of drug
resistance and adverse effects of long-term use of
drugs are quite common. In view of this and given
the fact that Ayurveda has guidelines to preserve
positive health and to provide relief from disease,
Renalka syrup was evaluated as treatment for UTI.
The polyherbal formulation has been significantly
effective in controlling and relieving clinical symptoms;
Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
15
review article
besides, it also has demonstrated antimicrobial efficacy
against the common urinary pathogens such as
E. coli, Klebsiella and B. proteus. The efficacy of Renalka
syrup can be attributed to the synergistic actions of
its constituent herbs. The potent herbs T. terrestris,
C. rotundus, V. zizanioides, Kshara parpati increase GFR,
and hence the urine output. But, they do not increase
excretion of electrolytes such as sodium, chloride and
bicarbonate as occurs with other diuretics. Herbs like
T. terrestris, C. magna, H. indicus, C. rotundus,
V. zizanioides, A. racemosus, Trikatu, E. cardamomum and
Kshara parpati possess analgesic and anti-inflammatory
properties and help to ameliorate symptoms of UTI
like dysuria and increased frequency. The beneficial
response of drug was observed within one week of
treatment and no untoward effects were observed
during the course of treatment.
Renalka syrup is an effective herbal formulation to
treat uUTI, which is safe and free from side effects.
Patients with cUTI, who do not respond well with
Renalka alone, need antimicrobial agents. Thus, it can
be concluded that Renalka syrup is an economical, safe
and effective herbal preparation in the management of
uUTI in adults.
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