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Wudpecker Journal of Pharmacy and Pharmocology Vol. 1(1), pp.

005 - 009, November 2012


Available online at http://www.wudpeckerresearchjournals.org
2012 Wudpecker Research Journals

Full Length Research Paper

Clinical evaluation of herbal coded formulation urolith


for treatment of urolithisis
Qalb E Saleem, Abdul Hannan, Khan Usmanghani, Halima Nazar, E. Mohiuddin, M. Akram
Faculty of Eastern Medicine, Hamdard University Karachi, Pakistan.

Accepted 15 October 2012

A study was conducted to investigate the efficacy of herbal coded formulation Urolith in comparison to
another herbal medicine Dawa e Pathri for treatment of urolithliasis. One hundred patients with
urolithiasis were randomly assigned into test and control with 50 in each group. The test group was
treated with Urolith and control group was treated with Dawa e Pathri. Comparison of data recorded by
physician relating to variables showed significant difference between test and control drug (p<0.05).
The efficacy of Urolith was superior as p=0.03. Urolith is more effective than Dawa e Pthri in the
treatment of Urolithiasis.

Key words: Urolith, Dawa e Pathri, urolithiasis, efficacy.

INTRODUCTION

Urolithiasis is a major public health problem with serious knowledge and art of healing that have been religiously
complications. Urolithiasis has become a global problem preserved for generations are not being passed on to the
in spite of advances in modern science. Patients with younger generation of today. Much of this traditional
urolithiasis constitute an important part of everyday knowledge on medicinal plants will likely be lost with the
urological practice. The optical management of this current elderly generation of healers.
disease requires knowledge of diagnostic procedures and Documentation and clinical trial study of this indigenous
treatment (Tiselius, 2001; Smith and Rosenfield, 1995; knowledge must therefore be accorded high priority if the
Kobayashi, 2003; Sudah, 2002). It leads to various future generation intends to benefit from it in overcoming
complications like kidney failure etc. Owing to these some of the new emerging problems in health, agriculture
complications, the researchers of different system of and pharmaceutical industry. It is the aim of present
medicine are concentrating themselves for the investigation that herbal medicine be evaluated in
development of the new urolithotriptic drugs. Different randomized clinical trials for its efficacy for the treatment
anti-urolithiasis drugs of main stream medicine have of urolithiasis.
potent and effective action, but the long term use of these
drugs results in development of various side effects.
Therefore, there is a need to develop safe and effective Study design
drug for the management of urolithiasis.
Thus, this study was planned to evaluate the efficacy of The study was carried out from June 2007 to June 2009.
herbal coded formulation in the management of The patients included in the trial were those reporting to
urolithiasis on scientific parameters. Herbal treatment the Outpatient Department. They were thoroughly
could be an alternate and complimentary therapy that examined for clinical signs and symptoms. Their lab
requires evidence based approach to eliminate urinary reports were recorded. Patients with all types of
stones. Unani medicines are in common use by the most urolithiasis, that was either newly detected or having
of the population of Pakistan and India. Accurate previous history was informed about the trial and were
knowledge of the plants and their medicinal activities are enrolled after signing consent form. Urine analysis, x-ray
held by only a few people. Unfortunately these invaluable and ultrasonography were performed. Patients with
satisfactory results for these studies were considered for
drug therapy. Patients with recent history of urinary tract
infection, diabetes mellitus, kidney failure, renal failure or
*Corresponding author E-mail: makram_0451@hotmail.com. cerebrovascular accidents were excluded from the study.
Saleem et al. 006

50 patients (aged 20 TO 60 years) were randomized to curve (AUC) using the trapezoidal rule. Statistical
receive Urolith (Dorema ammoniacum = 3gm, Nepeta analysis were performed using SPSS in cooperation with
Hindostana=3gm, Rauwolfia serpentine=2gm, Valeriana Mr. Syed Tashfeen Akhter, Assistant Manager, Takaful
officinalis=3gm and Bombax mori=5gm) in the double- Pakistan Limited, using excel and access database
blind, parallel group trial. software, the Chi Square are used for paired data. All
Then the patients received either 500mg tablet, two differences were considered statistically significant by
tablets thrice a day TID equally divided doses for three to generating a ‘p-value’ from Chi square test statistics.
four weeks. Selection of doses was on the basis of our
clinical practice and doses were adjusted whenever
necessary. At the end of 4 weeks of drug therapy Urine Study limitations
D/R, KUB X-ray or ultra-sound were repeated, drug
therapy was tapered off and patients’ numbers were The data was adjusted based on the number of cases in
decoded. Results are expressed as mean ± SEM. the light of demographic factor using statistical methods
A patient was categorized as a ‘responder’ if his or her like multinomial logistic regression. The data were
stone size at the end of the study period has become less composed in separate group. The groups were compared
or removed as compared to the initial stage. after random selection of subject in equal proportion
using SPSS software. The subject were divided into two
groups the case and the control groups. Finally, the case
SETTING and control groups were compared separately.

This case controlled examination based study was


conducted at Naveed-e-Sehat Dawakhana, Near Jubli Ethical issues
Cinema, Karachi and Shifa ul Mulk Memorial Hospital for
Eastern Medicine Hamdard University on the patient Ethical committee clearance and permission was
living in the rural areas of 27 to 70 villages surrounding obtained whenever necessary considering:
Madinat-ul-Hikamah Hamdard University, Karachi.
Hamdard, Karachi. a) Informing each participant of the study and
interviewing and examining the patient who consented to
participate in the study.
Sample selection b) Identity will not be revealed and the data would
be kept strictly confidential.
The sample was selected from the outpatients enrolled in c) Copy of the entire data will be made available to
Shifa-ul-Mulk Memorial Hospital for Eastern Medicine and the Shifa ul Mulk Memorial Hospital.
on the basis of preliminary clinical examination of the
patients who were suffering from urolithiasis, were
referred to the project officer and upon the basis of Inclusion criteria
inclusion and exclusion criteria the patient mashed as
candidate were selected. The study period include 2 The criteria for inclusion are:
years time from 2007 to 2009. Among this population all
the patient suffering from were interviewed immediately  Patients between age group of 20 to 60 years.
and upon their consent to participate they were grouped  Both genders are eligible for study.
as case and control group.  Evidence of urolithiasis
 Patients living in Karachi, Pakistan.
 All socio-economical classes including lower,
Data collection middle and upper.
 Acceptable for outpatient stone management
Data collected for this study included filling questionnaire
through personal interview, personal observation, use of
case record, file and documents. The clinical trial Exclusion criteria
proforma attached here which clearly specifies the clinical
feature and information.
The criteria for exclusion are:

 Urinary tract infection


Statistical analysis
 Known anatomical genitourinary (GU)
abnormalities, or prior GU surgeries
For comparison of the lithotriptic activity of these 2
agents, reduction in size of the stone or removal of stone  Diabetes
from 0 to 4 weeks was calculated as the area under the  Ulcer disease
007 Wudpecker J. Pham. Phamacol.

Table 1. Mean age of patients

Treatment Mean Std. Number


Group age Deviation (n)
Male 33.95 10.594 22
CONTROL DRUG (DAWA-A-
Female 36.46 10.651 28
PATHRI)
Total 35.36 10.592 50
Male 37.48 11.439 25
TEST DRUG (UROLITH) Female 37.80 8.190 25
Total 37.64 9.847 50
Male 35.83 11.075 47
Total Female 37.09 9.504 53
Total 36.50 10.239 100

Table 2. Distribution of age group in total patients.

Treatment Group Total


Age Group
Test (n) Control (n) (n)
20 – 25 Years 6 8 14
25 – 30 Years 4 7 11
30 – 35 Years 4 8 12
35 – 40 Years 15 12 27
40 – 45 Years 9 6 15
45 – 50 Years 6 3 9
50 – 55 Years 2 1 3
55 – 60 Years 4 5 9
Total 50 50 100

Table 3. Urolithisis sign and symtoms.

At base line No significane difference between test and control group P value=1
Burning Micturation:
After treatment No significant difference between test and control group P value:1
At base line No significane difference between test and control group P value=1
Dysurea
After treatment Significant difference between test and control group P value:0.03
At base line No significane difference between test and control group P value=.537
Haematurea
After treatment No Significant difference between test and control group P value:1
At base line No significane difference between test and control group P value=.399
Oligourea
After treatment No Significant difference between test and control group P value:1
At base line No significane difference between test and control group P value=.79
Right renal colic
After treatment No Significant difference between test and control group P value:1
At base line No significane difference between test and control group P value=.177
Left renal colic
After treatment No Significant difference between test and control group P value:1

Table 4. Ultrasound KUB in total patients at baseline.

Treatment Group
Total
Complaint at Baseline Control p value
Test (Urolith) (n)
(Dawa-a-Pathri)
Calcium Oxalate 35 34 69
Calcium Phosphate 8 10 18
Ultrasound KUB 0.85
Uric Acid 7 6 13
Total 50 50 50
Saleem et al. 008

Table 5. Ultrasound KUB in total patients at after treatment.

Treatment group
Total
Complaint at after treatment Control p value
Test (Urolith) (n)
(Dawa-a-Pathri)
Calcium Oxalate 04 11 15
Ultrasound KUB Complete Improvement 46 39 85 0.04
Total 50 50 50

 Osteoporosis both groups all patients enrolled with Urolithiasis having


 Pregnancy different type of stones i.e. calcium oxalate, calcium
 Psychiatric disorder phosphate and uric acid. In test groups out of 50 patients,
 History of hypersensitivity to tamsulosin or calcium oxalate were found in 35 cases, calcium
corticosteroids phosphate were found in 08 cases and uric acid were
 Spontaneous stone expulsion in the ED found in 07 cases. Whereas, in control group calcium
 Largest stone dimension .9mm oxalate was found in 34 cases, calcium phosphate was
 Concurrent use of vardenafil (Levitra) found in 10 cases and uric acid were found in 06 cases.
After applying Chi-square and Fisher’s Exact Test p value
 Solitary kidney
was calculated 0.85, which is greater than 0.05 as shown
 Transplanted kidney
in table 4. After treatment p value was 0.04 as shown in
 Renal insufficiency table 5 that indicates the efficacy of both medicine.
 Fever
 Prisoners or wards of state
DISCUSSION

RESULTS AND DISCUSSION Herbal coded formulation contains medicinal plants that
are commonly prescribed to treat kidney stones.
This study was under taken as an observational Medicinal plants used in this formulation are
paradigm in which an attempt was made to explore the ethnomedicinally paramount in Unani System of Medicine
urolithiasis patients taking herbal medicines so as to to treat various diseases of urinary tract. These medicinal
assess their efficacy. The collected data of 100 patients, plants hold rich source of secondary metabolites. In this
47 were males while 53 were female patients The study, an attempt has been made to investigate efficacy
patient’s gender, age, and baseline clinical features at the of this formulation to treat kidney stones.
time of enrolment were recorded in both treatment arms. Mi et al. (2012) has reported the antiurolithic effect and
The age distribution of over all patients, for Urolith and the possible mechanisms of Desmodium styracifolium
Dawa-a-Pathri are shown in Table 1. and Pyrrosiae petiolosa in rats. Prasad et al. (1993) has
All the patients were clearly categorized as having reported the antilithiatic activity of Musa (Paradisiaca
Urolithiasis. The demographic and baseline Linn. cultivar)--"Puttubale" stem juice in albino rats. Khan
characteristics of the patients included in the groups et al. (2011) has reported the antiurolithic activity of
evaluable for efficacy were found to be similar for the two Origanum vulgare through multiple pathways. Harsoliya
treatment groups and were comparable to those of the et al. (2011) has reported the efficacy of ethanolic
intent-to-treat population as p>0.05. All of the patients extracts of Bergenia ligulata, Nigella sativa and
recruited in this study were categorized in different class combination on calcium oxalate urolithiasis in rats.
interval ranging from 20 years of age to 60 years of age Garimella et al. (2001) has reported the in vitro
as shown in table 2. All patients had one or more antilithiatic activity of seeds of Dolichos biflorus and
pretreatment symptoms of Urolithiasis, which were rhizome of Begenia ligulata wall. Basir et al. (2009) has
almost same in both treatment groups as p >0.05 in table reported the antiurolithic effect of Bergenia ligulata
3 as mentioned below. rhizome. Mekap et al. (2011) has reported the
antiurolithiatic activity of Crataeva magna Lour. Bark.
Malini et al. (2000) has reported the protective effect of
Lab investigation response triterpenes on calcium oxalate crystals-induced
peroxidative changes in experimental urolithiasis.
Abdominal ultrasonography Varatharajan et al. (2008) has reported the antiurolithic
effect of lupeol and lupeol linolate in experimental
Clinically relevant ultrasound KUB at base line with hyperoxaluria. Shelkea et al. (2011) has reported the
Urolith and Dawa-a-Pathri were found to be similar in nephroprotective activity of ethanolic extract of stem
009 Wudpecker J. Pham. Phamacol.

barks of Crataeva nurvala Buch Ham. Kobayashi T (2003). Clinical characteristics of ureteral
Aslam et al. (2011) has reported the antiurolithic activity calculi detected by non enhanced computerized
of Origanum vulgare. Sridhar et al. (2011) has reported tomography after unclear results of plain radiology and
the antinephrolithiatic effect of Crataeva magna lour. Dc. ultrasonography, J Urol., 170: 799-802
root on ethylene glycol induced lithiasis. Malini MM, Lenin M, Varalakshmi P (2000). Protective
effect of triterpenes on calcium oxalate crystals-induced
peroxidative changes in experimental urolithiasis.
Conclusion Pharmacol. Res., 41(4): 413-18.
Mekap SK, Mishra S, Sahoo S, Panda PK (2011).
Urolith is more effective than the Dawa e Pathri in the Antiurolithiatic activity of Crataeva magna Lour. bark.
treatment of urolithiais as determined by p value <0.03. Indian J Nat Prod Resour., 2(1): 28-33.
Therefore control drug showed lesser efficacy than the Mi J, Duan J, Zhang J, Lu J, Wang H, Wang Z (2012).
test drug in its compliance to treat urolithiasis. The control Evaluation of antiurolithic effect and the possible
drug exhibited side effect like nausea and vomiting, mechanisms of Desmodium styracifolium and Pyrrosiae
where the test drug did not display or show any petiolosa in rats. Urol. Res., 40(2): 151-161.
untowards manifestation associated with the use of this Prasad KV, Bharathi K, Srinivasan KK (1993). Evaluation
medication and found acceptability by all treated patients. of Musa (Paradisiaca Linn. cultivar)--"Puttubale" stem
juice for antilithiatic activity in albino rats, Indian J.
Physiol. Pharmacol., 37(4):337-341.
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