Clinical evaluation of herbal coded formulation urolith for treatment ...

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

50 patients (aged 20 TO 60 years) were randomized to
receive Urolith (Dorema ammoniacum = 3gm, Nepeta
Hindostana=3gm, Rauwolfia serpentine=2gm, Valeriana
officinalis=3gm and Bombax mori=5gm) in the doubleblind,
parallel group trial.
Then the patients received either 500mg tablet, two
tablets thrice a day TID equally divided doses for three to
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
D/R, KUB X-ray or ultra-sound were repeated, drug
therapy was tapered off and patients’ numbers were
decoded. Results are expressed as mean ± SEM.
A patient was categorized as a ‘responder’ if his or her
stone size at the end of the study period has become less
or removed as compared to the initial stage.
SETTING
This case controlled examination based study was
conducted at Naveed-e-Sehat Dawakhana, Near Jubli
Cinema, Karachi and Shifa ul Mulk Memorial Hospital for
Eastern Medicine Hamdard University on the patient
living in the rural areas of 27 to 70 villages surrounding
Madinat-ul-Hikamah Hamdard University, Karachi.
Hamdard, Karachi.
Sample selection
The sample was selected from the outpatients enrolled in
Shifa-ul-Mulk Memorial Hospital for Eastern Medicine and
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 and exclusion criteria the patient mashed as
candidate were selected. The study period include 2
years time from 2007 to 2009. Among this population all
the patient suffering from were interviewed immediately
and upon their consent to participate they were grouped
as case and control group.
Data collection
Data collected for this study included filling questionnaire
through personal interview, personal observation, use of
case record, file and documents. The clinical trial
proforma attached here which clearly specifies the clinical
feature and information.
Statistical analysis
For comparison of the lithotriptic activity of these 2
agents, reduction in size of the stone or removal of stone
from 0 to 4 weeks was calculated as the area under the
Saleem et al. 006
curve (AUC) using the trapezoidal rule. Statistical
analysis were performed using SPSS in cooperation with
Mr. Syed Tashfeen Akhter, Assistant Manager, Takaful
Pakistan Limited, using excel and access database
software, the Chi Square are used for paired data. All
differences were considered statistically significant by
generating a ‘p-value’ from Chi square test statistics.
Study limitations
The data was adjusted based on the number of cases in
the light of demographic factor using statistical methods
like multinomial logistic regression. The data were
composed in separate group. The groups were compared
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
and control groups were compared separately.
Ethical issues
Ethical committee clearance and permission was
obtained whenever necessary considering:
a) Informing each participant of the study and
interviewing and examining the patient who consented to
participate in the study.
b) Identity will not be revealed and the data would
be kept strictly confidential.
c) Copy of the entire data will be made available to
the Shifa ul Mulk Memorial Hospital.
Inclusion criteria
The criteria for inclusion are:
� Patients between age group of 20 to 60 years.
� Both genders are eligible for study.
� Evidence of urolithiasis
� Patients living in Karachi, Pakistan.
� All socio-economical classes including lower,
middle and upper.
� Acceptable for outpatient stone management
Exclusion criteria
The criteria for exclusion are:
� Urinary tract infection
� Known anatomical genitourinary (GU)
abnormalities, or prior GU surgeries
� Diabetes
� Ulcer disease

007 Wudpecker J. Pham. Phamacol.
Table 1. Mean age of patients
CONTROL DRUG (DAWA-A-
PATHRI)
TEST DRUG (UROLITH)
Total
Table 3. Urolithisis sign and symtoms.
Burning Micturation:
Dysurea
Haematurea
Oligourea
Right renal colic
Left renal colic
Treatment Mean Std.
Number
Group
age Deviation (n)
Male 33.95 10.594 22
Female 36.46 10.651 28
Total 35.36 10.592 50
Male 37.48 11.439 25
Female 37.80 8.190 25
Total 37.64 9.847 50
Male 35.83 11.075 47
Female 37.09 9.504 53
Total 36.50 10.239 100
Table 2. Distribution of age group in total patients.
Age Group
Treatment Group
Test (n) Control (n)
Total
(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
At base line No significane difference between test and control group P value=1
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
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
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
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
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
After treatment No Significant difference between test and control group P value:1
Table 4. Ultrasound KUB in total patients at baseline.
Complaint at Baseline
Treatment Group
Test (Urolith)
Total
(n)
Control
(Dawa-a-Pathri)
Calcium Oxalate 35 34 69
Ultrasound KUB
Calcium Phosphate
Uric Acid
8
7
10
6
18
13
Total 50 50 50
p value
0.85

Table 5. Ultrasound KUB in total patients at after treatment.
Complaint at after treatment
Treatment group
Test (Urolith)
Total
(n)
Control
(Dawa-a-Pathri)
Calcium Oxalate 04 11 15
Ultrasound KUB Complete Improvement 46 39 85
Total 50 50 50
� Osteoporosis
� Pregnancy
� Psychiatric disorder
� History of hypersensitivity to tamsulosin or
corticosteroids
� Spontaneous stone expulsion in the ED
� Largest stone dimension .9mm
� Concurrent use of vardenafil (Levitra)
� Solitary kidney
� Transplanted kidney
� Renal insufficiency
� Fever
� Prisoners or wards of state
RESULTS AND DISCUSSION
This study was under taken as an observational
paradigm in which an attempt was made to explore the
urolithiasis patients taking herbal medicines so as to
assess their efficacy. The collected data of 100 patients,
47 were males while 53 were female patients The
patient’s gender, age, and baseline clinical features at the
time of enrolment were recorded in both treatment arms.
The age distribution of over all patients, for Urolith and
Dawa-a-Pathri are shown in Table 1.
All the patients were clearly categorized as having
Urolithiasis. The demographic and baseline
characteristics of the patients included in the groups
evaluable for efficacy were found to be similar for the two
treatment groups and were comparable to those of the
intent-to-treat population as p>0.05. All of the patients
recruited in this study were categorized in different class
interval ranging from 20 years of age to 60 years of age
as shown in table 2. All patients had one or more
pretreatment symptoms of Urolithiasis, which were
almost same in both treatment groups as p >0.05 in table
3 as mentioned below.
Lab investigation response
Abdominal ultrasonography
Clinically relevant ultrasound KUB at base line with
Urolith and Dawa-a-Pathri were found to be similar in
Saleem et al. 008
p value
0.04
both groups all patients enrolled with Urolithiasis having
different type of stones i.e. calcium oxalate, calcium
phosphate and uric acid. In test groups out of 50 patients,
calcium oxalate were found in 35 cases, calcium
phosphate were found in 08 cases and uric acid were
found in 07 cases. Whereas, in control group calcium
oxalate was found in 34 cases, calcium phosphate was
found in 10 cases and uric acid were found in 06 cases.
After applying Chi-square and Fisher’s Exact Test p value
was calculated 0.85, which is greater than 0.05 as shown
in table 4. After treatment p value was 0.04 as shown in
table 5 that indicates the efficacy of both medicine.
DISCUSSION
Herbal coded formulation contains medicinal plants that
are commonly prescribed to treat kidney stones.
Medicinal plants used in this formulation are
ethnomedicinally paramount in Unani System of Medicine
to treat various diseases of urinary tract. These medicinal
plants hold rich source of secondary metabolites. In this
study, an attempt has been made to investigate efficacy
of this formulation to treat kidney stones.
Mi et al. (2012) has reported the antiurolithic effect and
the possible mechanisms of Desmodium styracifolium
and Pyrrosiae petiolosa in rats. Prasad et al. (1993) has
reported the antilithiatic activity of Musa (Paradisiaca
Linn. cultivar)--"Puttubale" stem juice in albino rats. Khan
et al. (2011) has reported the antiurolithic activity of
Origanum vulgare through multiple pathways. Harsoliya
et al. (2011) has reported the efficacy of ethanolic
extracts of Bergenia ligulata, Nigella sativa and
combination on calcium oxalate urolithiasis in rats.
Garimella et al. (2001) has reported the in vitro
antilithiatic activity of seeds of Dolichos biflorus and
rhizome of Begenia ligulata wall. Basir et al. (2009) has
reported the antiurolithic effect of Bergenia ligulata
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
triterpenes on calcium oxalate crystals-induced
peroxidative changes in experimental urolithiasis.
Varatharajan et al. (2008) has reported the antiurolithic
effect of lupeol and lupeol linolate in experimental
hyperoxaluria. Shelkea et al. (2011) has reported the
nephroprotective activity of ethanolic extract of stem

009 Wudpecker J. Pham. Phamacol.
barks of Crataeva nurvala Buch Ham.
Aslam et al. (2011) has reported the antiurolithic activity
of Origanum vulgare. Sridhar et al. (2011) has reported
the antinephrolithiatic effect of Crataeva magna lour. Dc.
root on ethylene glycol induced lithiasis.
Conclusion
Urolith is more effective than the Dawa e Pathri in the
treatment of urolithiais as determined by p value