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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 such as indwelling urethral catheters, and are frequently
most prevalent microbial diseases and their asymptomatic are termed ‘complicated’ (cUTI).2,3
financial burden on society is substantial. The main causative pathogen involved in recurrent
These accounted for nearly seven million office visits UTI in women is Escherichia coli, which accounts for
and one million emergency department visits, resulting about 80% of all episodes. Other significant pathogens
in 1,00,000 hospitalizations in the US.1 include Staphylococcus saprophyticus, Klebsiella pneumoniae
UTI refers to the presence of microbial pathogens and Proteus mirabilis; each causes about 4% of all
within the urinary tract. Usually classified by the site of episodes of acute cystitis. Citrobacter and Enterococci
infection (bladder [cystitis], kidney [pyelonephritis] or are less likely causes of UTI in women.4
urine [bacteriuria]), these can also be asymptomatic In the classic theory for UTI development, the
or symptomatic, characterized by a wide-spectrum of uropathogen is a part of the fecal flora. It colonizes
symptoms ranging from mild irritative voiding to the vagina and distal urethra. It then ascends into the
bacteremia, sepsis or even death. UTIs that occur bladder and causes infection. This model is the same
in a normal genitourinary tract with no prior for sporadic and for recurrent UTI in women.5,6
instrumentation are termed ‘uncomplicated’ (uUTI), Reservoirs of uropathogenic bacteria can remain in
whereas infections that are associated with structural the gastrointestinal tract and vagina of the susceptible
or functional abnormalities, including instrumentation individual.
Diagnosis and management can be done based
*Associate Professor, Dept. of Urology
Dr BR Ambedkar Medical College and Hospital, Bangalore
on symptoms alone without further laboratory
**Medical Advisor confirmation. In complicated or questionable cases,
R&D Center, The Himalaya Drug Company, Makali, Bangalore urinalysis is done to confirm the diagnosis and to detect
Address for correspondence
Dr D Palaniyamma presence of urinary nitrites, red blood cells (RBCs), white
Medical Advisor blood cells (leukocytes), leukocyte esterase or bacteria.
R&D Center, The Himalaya Drug Company Urine culture is deemed positive, if it shows a bacterial
Makali, Bangalore - 562 123
E-mail: dr.palani@himalayahealthcare.com 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 of UTI. In this review, we discuss five clinical studies
out urine culture and sensitivity test which will be conducted with Renalka syrup.
useful in the selection of antibiotic treatment.7
Pharmacological actions of individual
UTI is the second most common clinical indication
herbs in Renalka Syrup
for empirical antimicrobial treatment in primary and
secondary care, and urine samples constitute the largest Renalka syrup contains principal ingredients like
single category of specimens examined in most medical Gokshura (Tribulus terrestris), Varuna (Crataeva magna),
microbiology laboratories.8 Sariva (Hemidesmus indicus), Musta (Cyperus rotundus),
Antibiotics such as fluoroquinolones (norfloxacin, Ushira (Vetiveria zizanioides), Shatavari (Asparagus
ciprofloxacin, pefloxacin), cephalosporins (cephalexin, racemosus), Trikatu, Ela (Elettaria cardamomum) and
cefaclor), trimethoprim-sulfamethoxazole and nitro- Kshara parpati.
furantoin are commonly used. Choice of antibiotic Gokshura or (T. terrestris): It has remarkable anti-
should rely on community patterns of resistance, inflammatory and analgesic actions to reduce pain, as
adverse events and local costs. Antibiotics are usually noticed during dysuria. The anti-inflammatory action
effective in treating acute infections and are the primary normalizes the mucosa.13 It also has antimicrobial
means of prophylaxis for recurrent UTI patients; but, actions against common etiopathogens.14 T. terrestris
their utility is declining by the emergence of increasing has potent diuretic action that increases blood flow
numbers of drug-resistant bacteria.9 At least 50% of in the kidneys.15 This, in turn, increases glomerular
men with recurrent UTI10 and over 90% of men with filtration rate (GFR), and hence urinary output. Though
febrile UTI11 have prostate involvement, which may it increases the excretion of water, it does not increase
lead to complications such as prostatic abscess or elimination of electrolytes such as sodium, chloride
chronic bacterial prostatitis.
and bicarbonate as occurs with other diuretics. This
Each system of the body has its own physiological action is useful in conditions such as pyelonephritis,
pH value and variation too far from that pH range, urethritis and cystitis and also prevents urolithiasis
increases susceptibility to disease. Humans live in that result from stasis of the urine in kidneys. It is
an acidic environment with poor quality and highly renoprotective by increasing chloride and creatinine
processed foods, polluted water and air, environmental clearance from the body.15
toxins, poor breathing techniques and acidifying
Varuna (C. magna): It has remarkable anti-inflammatory
prescription medications consistently adding to the
and analgesic actions to reduce pain on urination
acidic burden of the body. Most diseases arise from
(dysuria). The anti-inflammatory action normalizes
an acidic milieu. An acidic body is a reactive body,
the mucosa.16 It is useful in urolithiasis and other
thus by reducing acidity, one can also reduce allergic
disorders of the urinary tract.17
symptoms, tendency towards inflammation and
reverse the trend towards chronic conditions. An Sariva (H. indicus): It is renoprotective against
alkalizer helps to reduce tissue acidosis and shift chemically-induced nephrotoxicity.18 The potent
the acid-base balance to a normal range, promoting antioxidants in the herb protect the genitourinary
good health and well-being. Dysuria is attributed to system from oxidative tissue damage.19,20 Due to its
the acidic urine, due to bacterial infection. Therefore, probably alterative and urinary supportive actions, it
alkalinization of the urine may provide symptomatic normalize urinary pH.21
relief.12
Musta (C. rotundus): The anti-inflammatory and
Recently, there has been greater emphasis on the analgesic actions reduce pain of dysuria.22 C. rotundus
search for herbal preparations that can be help in has potent diuretic action that increases blood flow in
the management of urinary disorders. In the Indian the kidneys. This, in turn, increases GFR and hence
medical literature, many drugs have been advocated the urine output.23
for this indication. Renalka syrup is a well-balanced,
Ushira (V. zizanioides): The potent diuretic action of
multi-ingredient formula with proven value in a
this herb increases GFR and the urine output.
variety of urinary disorders. It is a natural and effective
alkalizer, not only relieves burning micturition, but also This process increases the amount of water excreted,
soothes inflamed urinary mucosa. It restores normal but does not increase elimination of electrolytes such as
urinary pH and normalizes the frequency of sodium, chloride and bicarbonate as occurs with other
micturition. It is effective for long-term prophylaxis diuretics.24

12 Indian Journal of Clinical Practice, Vol. 22, No. 12, May 2012
review article

Shatavari (A. racemosus): It has antimicrobial actions followed-up at regular intervals to evaluate its effect
against common etiopathogens involved in UTIs.25 and also to rule out any side effects. The response
It also has inhibits lithiasis and reduces the weight to the drug (Renalka syrup) was observed by urine
of stones.26 The antioxidants in the herb protect examination and culture, total leukocyte count (TLC)
the genitourinary system from oxidative tissue and differential leukocyte count (DLC). The results
damage.27,28 were assessed based on patients’ response as very good,
Trikatu: An Ayurvedic formulation comprises a 1:1:1 good and poor. Results: Of the 36 patients diagnosed
with cystitis, 18 patients (50%) improved within a week,
ratio of dried fruits of Piper nigrum, P. longum and
10 (28%) responded well after two weeks of treatment
dried rhizomes of Zingiber officinale. Piperine from
and two patients (5%) showed response after 3 weeks
P. nigrum is rapidly absorbed across the intestinal
of treatment. But, only six patients (17%) required
barrier, and acts as an apolar molecule forming apolar
adjuvant oral antibiotics before they responded
complex with drugs and solutes. This modulates
(Table 2). No patient developed any side effects that
membrane dynamics, due to its easy partitioning thus
would have required either reduction in the dose or
increasing permeability across the barriers. These
omission of the drug. No patients withdrew from the
membrane modulations enhance bioavailability of
trial. Conclusion: Renalka syrup is effective in the
nutrients and medications.29
treatment of cystitis and chronic prostatitis, without
Ela (E. cardamomum): It has remarkable anti- producing any undesirable side effects. In chronic UTIs,
inflammatory and analgesic actions to reduce pain, as it may be useful for long-term prophylaxis. However, a
noticed during dysuria. The anti-inflammatory action larger clinical trial is proposed to evaluate its efficacy in
normalizes the mucosa.30 a wider perspective.
Kshara parpati: Its potent diuretic action increases
blood flow in the kidneys, which increases GFR and Study 2: UTI and Its Management by Renalka33
hence the output of urine. Though water excretion Material and methods: The present clinical trial was
is increased, but excretion of electrolytes (sodium, carried out in 30 female patients in the age group of
chloride and bicarbonate) is not increased. The 22-46 years, attending Prasuti Tantra OPD of SS
urinary pH is normalized possibly due to alterative Hospital, Institute of Medical Sciences, Banaras
and urinary supportive actions.31 Hindu University, Varanasi. A complete history of the
patients was recorded in a specially prepared research
Clinical studies proforma and patients were registered in the trial
with an informed consent for the given treatment.
Study 1: Clinical Trial on Renalka Syrup in UTI32 Urine analysis and culture was done in all the cases
before starting the clinical trial. Renalka syrup was
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, Table 1. Symptom-wise Grouping of Patients32
hematuria and pyuria were enrolled in the study Symptom No. of patients
(Table 1). UTI was diagnosed on the basis of clinical Cystitis 36
features and examination. Written informed consent Prostatitis 10
was obtained from each patient. The study subjects Prostatic abscess 1
were administered Renalka syrup at a dose of two
Pyelonephritis 3
teaspoonfuls twice-daily for 2-4 weeks. They were

Table 2. Response to Treatment with Renalka Syrup32


Indication Response to treatment with Renalka syrup Adjuvant therapy
1 week 2 weeks 3 weeks (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. urinalysis, urine culture, hemoglobin (Hb), TLC, DLC,
Weekly urine analysis was done and clinical findings urea, creatinine and blood glucose estimation, including
were recorded. Urine culture was treated at the end of ultrasonography/X-ray KUB. Prostate was examined
four weeks treatment. The final assessment of results in patients aged 60 or above. Paracetamol was used
was done at the end of four weeks. Twenty-six patients if fever was >101°F. Antibiotics were withdrawn in all
complained of burning micturition, 21 had frequency patients included in this study. Renalka syrup was given
of urination, 12 patients had severe dysuria with orally at a dose of two teaspoonfuls, twice-daily before
mild-to-moderate fever and 12 only had dysuria as a breakfast and after dinner for 2-4 weeks depending
presenting symptom. Renalka syrup was given twice- upon clinical response. Treatment efficacy was assessed
daily as 2 teaspoonfuls for four weeks.Urine culture was weekly using clinical/or bacteriological criteria. Patients
done in all 30 patients prior to treatment. The culture with cUTI not responding to Renalka syrup in a week’s
was positive in 90%. Results were assessed based on
time were given suitable antibiotics depending upon
patients’ response as very good, good and poor. Urine
urinary pathogens and their sensitivity pattern. The
analysis revealed the presence of albumin in 20 patients,
factors responsible for cUTI were noted in each patient.
pus cells in 23 patients, epithelial cells in 19 patients
Results: Twenty-eight (70%) patients showed good
and RBCs in five patients. Results: There was marked
clinical response to Renalka; three patients were lost for
relief in burning micturition (96.15%) and frequency
follow-up (Table 4). Most patients were given the drug
of micturition (95.23%). Eleven out of 12 patients
showed relief in dysuria with mild fever (91.66%), for two weeks and three cases continued treatment
whereas all the patients had complete relief of dysuria for 4 weeks. None of the patients developed any side
(Table 3). Renalka syrup was also found to be effective effects, which would have required a reduction of the
against pathogens like E. coli, B. proteus, Klebsiella and dose or omission of the drug. Three patients withdrew
Pseudomonas (Table 4). No side effects, which would from the trial. Conclusion: Renalka syrup is an effective
have required a dose reduction or omission of the drug, herbal formulation in treatment of uUTI. Patients with
were reported. No patients withdrew from the trial. cUTI who do not respond well with Renalka alone
Conclusion: Renalka, an Ayurvedic preparation has need antimicrobial agents. Thus, Renalka syrup is an
proved its efficacy and safety in chronic UTI. The trial economical, safe and effective herbal preparation in the
drug was quite effective in controlling and relieving management of uUTI in adults.
clinical symptoms significantly.
Study 4: Effect of Renalka Syrup in UTI35
Study 3: Renalka Syrup in the Treatment of UTI34 Material and methods: Forty patients of either
Material and methods: All patients included in the sex, of different age groups with complaints like
study were subjected to a detailed clinical examination, 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 administered at a dose of two teaspoonfuls twice-daily
Hospital, Institute of Medical Sciences, Banaras before breakfast and dinner. Specific antibiotics as per
Hindu University, Varanasi, were enrolled in the culture sensitivity report were added to the Renalka
study. Complete clinical examinations, hematological syrup group and to the placebo group besides the drug
investigations like TLC, DLC, Hb, blood urea, serum and placebo. Follow-up was done every 2 weeks for
creatinine, urine examination (routine and microscopic six weeks. Urine routine and culture was also done at
and culture and sensitivity) and ultrasonography these visits. Results: Out of 32 patients in the Renalka
for urine bladder, kidney and prostate were done on group, eight patients had acidic urine at admission.
each patient. Subjects with malignancy, pregnancy, At the end of treatment, only one showed acidic urine.
renal failure, cerebrovascular episodes, nonconcomitant In the placebo group, 21 patients had acidic urine and
severe illness necessitating other treatment modes, at the end of six weeks, 22 cases persisted to show
AIDS, congenital deformity and tuberculosis, were acidic urine. None of these patients showed alkaline
excluded. Antibiotic and alkalizing drugs, which are urine pH after six weeks in placebo group. Out of
commonly used in UTI, were withdrawn. Renalka 19% (4 cases) passing acidic urine at admission, only
syrup was given at a dose of 2 teaspoonfuls, thrice- 4.76% (one) was acidic at six weeks in the Renalka and
daily before meals for four weeks. Patients were in almost all the cases (95.24%), urine was alkaline at
assessed weekly on the basis of their symptoms and six weeks. In the patients in Renalka group, urine
clinical findings. All laboratory investigations were also culture showed E. coli as the commonest pathogen (16)
repeated every week. Results: Patients, who presented followed by Klebsiella (9), Proteus (2) and five patients
with various symptoms of UTIs, were categorized culture did not reveal any organism on admission to
into two major groups, having indwelling catheters the study. Patients on the placebo showed the following
21 cases (52.5%), or without indwelling catheters, pathogens E. coli (15), Klebsiella (8), Proteus (2) and
19 (47%). TLC, DLC, Hb, blood urea and serum urine of five patients was sterile at the beginning of
creatinine were routinely done before, during and the study. At the end of six weeks 22 patients (68.75%)
at end of therapy and no significant changes were the urine became sterile in the Renalka group, whereas
observed after treatment with Renalka syrup. None only nine patients (30%) were sterile in placebo group.
of the patients developed any side effects, which None of the patients developed any side effects,
would have required a reduction of the dose or which would have required a reduction of the dose or
omission of the drug. No patients withdrew from the omission of the drug. No patients withdrew from the
trial. Conclusion: Renalka syrup can be safely used trial. Conclusion: Renalka syrup was found to be very
effective control of symptoms like burning micturition
effective in symptomatic improvement of UTI within
and frequency of micturition in UTI. It is also
two weeks in terms of dysuria, frequency, fever and
effective in eradicating common urinary etiopathogens
fever with chills and rigor as well as changing urinary
like E. coli.
pH to alkaline medium. It was effective in preventing
Study 5: Renalka in UTI in Traumatic Paraplegia UTI recurrence. It also has antibacterial activity as
Patients36 evident by the decrease in bacterial colony count and
absence of pus cells in the urine. No side effects were seen
Material and methods: One hundred patients of with drug or placebo. There was good response in terms
either sex aged between 20-60 years were included in of compliance.
the trial. They were divided into two groups: Group I
included 62 patients with significant bacteriuria with CONCLUSION
symptoms of increased frequency, dysuria, fever or
fever with chills and rigor; Group II, which included UTI is a common disorder in all age groups and in
38 patients who were asymptomatic but had significant both sexes worldwide. Though several antibiotics
bacteriuria. Patients with history of malignancy, renal are available for treatment, the problem of drug
failure and a nonconcomitant severe illness necessitating resistance and adverse effects of long-term use of
other treatment modes were excluded from the study. drugs are quite common. In view of this and given
Baseline complete urine examination with culture and the fact that Ayurveda has guidelines to preserve
sensitivity was done. In Group I, 32 patients (51.61%) positive health and to provide relief from disease,
were on Renalka syrup and 30 (48.38%) were on Renalka syrup was evaluated as treatment for UTI.
placebo. In Group II, 21 (55%) were on Renalka syrup The polyherbal formulation has been significantly
and 17 (45%) were on placebo. Renalka syrup was 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 14. Ali NA, Julich WD, Kusnick C, Lindequist U.
against the common urinary pathogens such as J Ethnopharmacol 2001;74(2):173-9.
E. coli, Klebsiella and B. proteus. The efficacy of Renalka 15. Al-Ali M, Wahbi S, Twaij H, Al-Badr A. J Ethnopharmacol
syrup can be attributed to the synergistic actions of 2003;85(2-3):257-60.
its constituent herbs. The potent herbs T. terrestris, 16. Asolkar LV, Kakkar KK, Chakre OJ. Crataeva magna.
C. rotundus, V. zizanioides, Kshara parpati increase GFR, Glossary of Medicinal Plants with Active Principles.
and hence the urine output. But, they do not increase Publications & Information Directorate (CSIR), New
excretion of electrolytes such as sodium, chloride and Delhi. Second Supplement 1992:p.236.
bicarbonate as occurs with other diuretics. Herbs like 17. Yoganarasimhan SN. Crataeva magna. Medicinal Plants of
T. terrestris, C. magna, H. indicus, C. rotundus, India-Tamil Nadu, Bangalore 2000;2:p.159.
V. zizanioides, A. racemosus, Trikatu, E. cardamomum and 18. Kotnis MS, Patel P, Menon SN, Sane RT. Nephrology
Kshara parpati possess analgesic and anti-inflammatory (Carlton) 2004;9(3):142-52.
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response of drug was observed within one week of 20. Ravishankara MN, Shrivastava N, Padh H, Rajani M.
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Renalka syrup is an effective herbal formulation to
treat uUTI, which is safe and free from side effects. 22. Seo WG, Pae HO, Oh GS, Chai KY, Kwon TO, Yun YG,
et al. J Ethnopharmacol 2001;76(1):59-64.
Patients with cUTI, who do not respond well with
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be concluded that Renalka syrup is an economical, safe Glossary of Medicinal Plants with Active Principles.
Publications & Information Directorate (CSIR), New Delhi
and effective herbal preparation in the management of
1992;Suppl 2:p.254.
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24. Yoganarasimhan SN. Vetiveria zizanioides. Medicinal
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