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Wudpecker Journal of Pharmacy and Pharmocology Vol. 1(1), pp. 005 - 009, November 2012Available online at http://www.wudpeckerresearchjournals.org2012 Wudpecker Research Journals

Full Length Research Paper

Clinical evaluation of herbal coded formulation urol ith

for treatment of uroli thisisQalb 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 eff icacy of herbal coded formulation Uroli th in comparison toanother herbal medicine Dawa e Pathri for treatment of urolithliasis. One hundred patients withurolithiasis were randomly assigned into test and control with 50 in each group. The test group wastreated 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


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50 patients (aged 20 TO 60 years) were randomized toreceive Urolith (Dorema ammoniacum = 3gm, NepetaHindostana=3gm, Rauwolfia serpentine=2gm, Valerianaofficinalis=3gm and Bombax mori=5gm) in the double-blind, parallel group trial.

Then the patients received either 500mg tablet, two

tablets thrice a day TID equally divided doses for three tofour weeks. Selection of doses was on the basis of ourclinical practice and doses were adjusted whenevernecessary. At the end of 4 weeks of drug therapy UrineD/R, KUB X-ray or ultra-sound were repeated, drugtherapy was tapered off and patients numbers weredecoded. Results are expressed as mean SEM.

A patient was categorized as a responder if his or herstone size at the end of the study period has become lessor removed as compared to the initial stage.

SETTING

This case controlled examination based study wasconducted at Naveed-e-Sehat Dawakhana, Near JubliCinema, Karachi and Shifa ul Mulk Memorial Hospital forEastern Medicine Hamdard University on the patientliving in the rural areas of 27 to 70 villages surroundingMadinat-ul-Hikamah Hamdard University, Karachi.Hamdard, Karachi.

Sample selection

The sample was selected from the outpatients enrolled inShifa-ul-Mulk Memorial Hospital for Eastern Medicine and

on the basis of preliminary clinical examination of thepatients who were suffering from urolithiasis, werereferred to the project officer and upon the basis ofinclusion and exclusion criteria the patient mashed ascandidate were selected. The study period include 2years time from 2007 to 2009. Among this population allthe patient suffering from were interviewed immediatelyand upon their consent to participate they were groupedas case and control group.

Data collection

Data collected for this study included filling questionnairethrough personal interview, personal observation, use ofcase record, file and documents. The clinical trialproforma attached here which clearly specifies the clinicalfeature and information.

Statistical analysis

For comparison of the lithotriptic activity of these 2agents, reduction in size of the stone or removal of stonefrom 0 to 4 weeks was calculated as the area under the

Saleem et al. 006

curve (AUC) using the trapezoidal rule. Statisticaanalysis were performed using SPSS in cooperation withMr. Syed Tashfeen Akhter, Assistant Manager, TakafuPakistan Limited, using excel and access databasesoftware, the Chi Square are used for paired data. Aldifferences 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 inthe light of demographic factor using statistical methodslike multinomial logistic regression. The data werecomposed in separate group. The groups were comparedafter random selection of subject in equal proportionusing SPSS software. The subject were divided into twogroups the case and the control groups. Finally, the caseand control groups were compared separately.

Ethical issues

Ethical committee clearance and permission wasobtained whenever necessary considering:

a) Informing each participant of the study andinterviewing and examining the patient who consented toparticipate in the study.b) Identity will not be revealed and the data wouldbe kept strictly confidential.c) Copy of the entire data will be made available tothe 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 lowermiddle and upper.

Acceptable for outpatient stone management

Exclusion criteria

The criteria for exclusion are:

Urinary tract infection

Known anatomical genitourinary (GUabnormalities, or prior GU surgeries

Diabetes

Ulcer disease


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007 Wudpecker J. Pham. Phamacol.

Table 1. Mean age of patients

TreatmentGroup

Meanage

Std.Deviation

Number(n)

CONTROL DRUG (DAWA-A-PATHRI)

Male 33.95 10.594 22

Female 36.46 10.651 28

Total 35.36 10.592 50

TEST DRUG (UROLITH)

Male 37.48 11.439 25

Female 37.80 8.190 25

Total 37.64 9.847 50

Total

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 GroupTreatment Group Total

(n)Test (n) Control (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.

Burning Micturation: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

DysureaAt base line No significane difference between test and control group P value=1After treatment Significant difference between test and control group P value:0.03

HaematureaAt 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

OligoureaAt base line No significane difference between test and control group P value=.399


Right renal colicAt base line No significane difference between test and control group P value=.79


Left renal colicAt base line No significane difference between test and control group P value=.177


Table 4. Ultrasound KUB in total patients at baseline.

Complaint at BaselineTreatment Group

Total(n)

p valueTest (Urolith)

Control(Dawa-a-Pathri)

Ultrasound KUB

Calcium Oxalate 35 34 69

0.85Calcium Phosphate 8 10 18

Uric Acid 7 6 13

Total 50 50 50


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Saleem et al. 008

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

Complaint at after treatmentTreatment group

Total(n)

p valueTest (Urolith)

Control(Dawa-a-Pathri)

Ultrasound KUB

Calcium Oxalate 04 11 15

0.04Complete Improvement 46 39 85

Total 50 50 50

Osteoporosis

Pregnancy Psychiatric disorder

History of hypersensitivity to tamsulosin orcorticosteroids

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 observationalparadigm in which an attempt was made to explore theurolithiasis patients taking herbal medicines so as toassess their efficacy. The collected data of 100 patients,47 were males while 53 were female patients Thepatients gender, age, and baseline clinical features at thetime of enrolment were recorded in both treatment arms.The age distribution of over all patients, for Urolith andDawa-a-Pathri are shown in Table 1.

All the patients were clearly categorized as havingUrolithiasis. The demographic and baselinecharacteristics of the patients included in the groupsevaluable for efficacy were found to be similar for the twotreatment groups and were comparable to those of theintent-to-treat population as p>0.05. All of the patientsrecruited in this study were categorized in different classinterval ranging from 20 years of age to 60 years of ageas shown in table 2. All patients had one or more

pretreatment symptoms of Urolithiasis, which werealmost same in both treatment groups as p >0.05 in table3 as mentioned below.

Lab investigation response

Abdominal ul trasonography

Clinically relevant ultrasound KUB at base line withUrolith and Dawa-a-Pathri were found to be similar in

both groups all patients enrolled with Urolithiasis havingdifferent type of stones i.e. calcium oxalate, calciumphosphate and uric acid. In test groups out of 50 patientscalcium oxalate were found in 35 cases, calciumphosphate were found in 08 cases and uric acid werefound in 07 cases. Whereas, in control group calciumoxalate was found in 34 cases, calcium phosphate wasfound in 10 cases and uric acid were found in 06 cases.

After applying Chi-square and Fishers Exact Test p value

was calculated 0.85, which is greater than 0.05 as shownin table 4. After treatment p value was 0.04 as shown intable 5 that indicates the efficacy of both medicine.

DISCUSSION

Herbal coded formulation contains medicinal plants thaare commonly prescribed to treat kidney stonesMedicinal plants used in this formulation areethnomedicinally paramount in Unani System of Medicineto treat various diseases of urinary tract. These medicinaplants hold rich source of secondary metabolites. In thisstudy, an attempt has been made to investigate efficacyof this formulation to treat kidney stones.

Mi et al. (2012) has reported the antiurolithic effect andthe possible mechanisms of Desmodium styracifoliumand Pyrrosiae petiolosa in rats. Prasad et al. (1993) hasreported the antilithiatic activity of Musa (ParadisiacaLinn. cultivar)--"Puttubale" stem juice in albino rats. Khanet al. (2011) has reported the antiurolithic activity oOriganum vulgare through multiple pathways. Harsoliyaet al. (2011) has reported the efficacy of ethanolicextracts of Bergenia ligulata, Nigella sativa andcombination on calcium oxalate urolithiasis in rats.

Garimella et al. (2001) has reported the in vitroantilithiatic activity of seeds of Dolichos biflorus and

rhizome of Begenia ligulata wall. Basir et al. (2009) hasreported the antiurolithic effect of Bergenia ligulatarhizome. Mekap et al. (2011) has reported theantiurolithiatic activity of Crataeva magna Lour. BarkMalini et al. (2000) has reported the protective effect otriterpenes on calcium oxalate crystals-inducedperoxidative changes in experimental urolithiasisVaratharajan et al. (2008) has reported the antiurolithiceffect of lupeol and lupeol linolate in experimentalhyperoxaluria. Shelkea et al. (2011) has reported thenephroprotective activity of ethanolic extract of stem


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barks of Crataeva nurvala Buch Ham.Aslam et al. (2011) has reported the antiurolithic activity

of Origanum vulgare. Sridhar et al. (2011) has reportedthe antinephrolithiatic effect of Crataeva magna lour. Dc.root on ethylene glycol induced lithiasis.

Conclusion

Urolith is more effective than the Dawa e Pathri in thetreatment of urolithiais as determined by p value

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