Research Article
Intern
ternational Ayurvedic Medical Journal
ISSN:2320
I
5091
TO EVALUATE THE POTENTIAL OF YAVA PANEEYA KSHARA (ALKALI
PREPARATION OF BARLEY) ON NEPHROLITHIASIS A PILOT STUDY
Chakradha
adhar K. V.,
Dattatreya Rao. S
drapradesh, India
P.G. Department of Shalya,, S.V. A
Ayurvedic Medical College, Tirupati, Andrapr
ABSTRACT
Objective:-Renal calculi are one among such diseases which is associated with recurrence even
after removal by surgery in most
ost of the cases. In this study, Yava Kshara (Alka
Alkali preparation of
Barley) is used to explore the suppor
supportive evidence of Litholytic activity in the management of
existing and recurrent Nephrolit
olithiasis. Method: - A comparative study wass conducted
c
on 20
patients. 10 patients of Group
oup I rrecieved Yava Kshara and remaining 10 patient
ents were given an
indigenous drug called GCP Com
ompound for a period of 60 days. The size of renal
r
calculi was
studied by periodic ultrasonogra
ographic assessmement in both groups. Mechanis
nistic and clinical
studies evaluating the use of the
these agents were identified using the Medline
ine data base. The
articles were then critically review
viewed and summarized. Results: - Statistical anal
nalysis showed that
P - value of less than 0.05 wa
was seen in Group I from 0 to 60 days course
ourse. There was no
significant difference observedd in tthe stone size in Group II when the actual value and calculated
value were compared. Conclusi
usion: - Yava Kshara can be used to reduce the recurrence of
calcium oxalate stone (Vatajaa As
Ashmari) and it is shown to have better result
ult than the use of
indigenous GCP Compound inn suc
such cases.
Keywords: Ashmari, GCP Compound,
ompound, Paneeya kshara , Renal calculi, Yava
a kshara
kshar
INTRODUCTION
A number of people suffer from
rom problems
due to urinary stones (calculi).
). As much as
10.0% of men and 3.0% of wom
women have
stone at least once, during their
ir aadult life [1].
Areas of high incidence of urina
urinary calculi
worldwide include the Britishh Isl
Isles, Scandinavian countries, northern Austra
Australia, central
Europe, northern India, Pakistan
tan and Medi[2] [3]
terranean Countries
. Sauras
urashtra region
of Gujarat has higher prevalence
nce of urinary
stones. According to an estimate
ate every year,
6, 00,000 Americans suffer from urinary
stones [4]. In India, 12% of the popul
population is
expected to have urinary stone
tones, out of
which 50% may end up with loss
oss of kidneys
or renal damage. Also, nearlyy 15% of the
population of northern India suf
suffers from
[5]
kidney stones . Calcium stone
ones are most
common, comprising 75% of all urinary calculi [6]. Although, development
nt of modern
techniques such as Extracorporeal
Extrac
shock
[7
[7]
wave lithotripsy (ESWL)
and Percutaneous nephrolithotomy (PCN
NL) have revolutionized surgical manageme
ment of the problem, yet not much progress
ess has been made
towards the medical manage
nagement of kidney
stone problem. Patients may
ay experience discomfort, soreness or pain
n at the treatment
site. A prescription for pain
ain relieving medication or extra strength of acetaminophen
a
is
recommended. Some patient
ents also show discomfort or pain as particles
es pass through the
ureter. A large number of Indian
I
medicinal
plants are being routinely used
us by practitioners of Ayurvedic system of medicine in the
treatment of urinary stone
tone disease [6][7].
Many plants have also been
r
en reported
all over
the world which is able to inhibit kidney
stones [7][8] [9][10][11].Size of the stone is also a
very important disposing
ng factor. It was
m in size sponta found that the stone ≤5 mm
Chakradhar K. V. & Dattatreya Rao. S to Evaluate the Potential of Yava Paneeya Kshara (Alkali Preparation of Barley) on
Nephrolithiasis A Pilot Study
neously passes through the urine, whereas
the size more than it is to be treated properly. Most of the time, greater than 10 mm
size of stone has been treated surgically. Location of the stone is also an important factor [12] from treatment point of view. Acute
renal colic has symptoms like intermittent
colic pain radiating toward lower abdomen,
backache, etc. and often associated with
symptoms like nausea, vomiting, etc.; lower
urinary symptoms like urgency in micturition, dysuria and frequency may also be present [13]. Management of renal calculi is dependent upon size and location of the stone;
unbearable pain for the calculi more than 10
mm requires strong analgesics and surgical
measures as drugs dissolving such stones
have so far been unsuccessful. However, the
stones less than this size have been treated
successfully using herbal medicines which
have posses diuretic, anti-inflammatory, antimicrobial[2][3] and antispasmodic activities
[14][15]
. An alarming rise in the incidence of
urolithiasis coupled with a motivation provided by W.H.O. (World Health Organization) to explore the possibility of discovering cure on traditional line has created an
impetus for further research in the light of
Ayurvedic knowledge. So, here an attempt
has been made to evaluate the potential of
Yava Paneeya Kshara on nephrolithiasis.
AIMS AND OBJECTIVES
1. To study the Litholytic activity of Yava
Kshara (Alkali preparation of Barley).
2. To study the disease Renal Calculi in
terms of its etiopathogenesis, clinical manifestations with possible correlation to the
description available in modern and Ayurveda medicine for Urolithiasis.
3. To evaluate the safety and efficacy of
Ayurvedic formulation in patients with urolithiasis by assessing the symptomatic relief,
reduction/expulsion of renal stones, urinary
biochemical parameters.
Grouping:
31
www.iamj.in
All the patients in the present study have
been divided into two groups, containing 10
patients in each group.
Group I: 10 patients (Yava Paneeya Kshara)
–EXPERIMENTAL GROUP
Group II: 10 patients (GCP Compound) –
CONTROL GROUP
MATERIALS AND METHODS
Total 20 patients were taken up for study
from P.G. Department of Shalya, considering selection criteria based on inclusion and
exclusion criteria.10 patients were given
Yava Kshara (Alkali preparation of Barley)
400mg twice in a week internally mixed
with 200 ml of sterile water, before meal in
the morning for a period of 6 weeks. Remaining 10 patients were given GCP Compound (An indigenous compound prepared
out of Gokshuradi guggulu, Chandraprabha
Vati, Punarnavadi mandoora in equal quantities) internally with dosage of 500 mg BID
schedule for a period of 6 weeks. Renal
stones were diagnosed by X-ray kidney,
ureter and bladder (KUB) and ultrasonography. Both the groups were subjected for a
subjective parameters (Pain, Burning micturition, Dysuria, Tenderness at renal angle)
and Objective parameters (X-ray KUB, USG
KUB) following a standard proforma [13].
USG for KUB determines size, consistency
and location of calculus and it play an important role in assessing objective criteria. In
both the groups all the patients were instructed to follow their normal dietetics and
to maintain regular intervals in between the
two meals. All the patients were advised to
resist from all the diets which are directly or
indirectly contributory to the formation of
stone. Further all the patients were instructed to take plenty of water [14].
4.2. Drug Study:
Kshara (alkali) preparation of Barley
(Yava Kshara Nirmaņ a Vidhi): This is an
alkali substance, which is being prepared
from the breads of Barley by adopting procedure of Kshara Nirmana Vidhi as per text.
Dry Yava Panchanga should be divided into
IAMJ: Volume 1; Issue 6; Nov Dec2013
Chakradhar K. V. & Dattatreya Rao. S to Evaluate the Potential of Yava Paneeya Kshara (Alkali Preparation of Barley) on
Nephrolithiasis A Pilot Study
small pieces, ignited by sesam
samum stalks
(Tila) with pebbles of limestone
one. When the
fire has burnt out, the ash and
nd the slake lime
was collected separately. Thenn one Droņ a
(10.24KGs) of the ash shouldd be di
dissolved in
six Droņ ās of water and filtere
ered 21 times
and should be treated on fire in a big pan,
while it is slowly stirred by a ladl
ladle. When it
becomes clear, red, sharp and slimy, it
should be filtered through a wide piece of
fine cloth and the filtrate should
hould be placed
again on fire after removing
ng the separated
residue [16].
4.3. GCP Compound: A com
ompound prepared out of Gokshuradi guggul
guggulu - 50gms,
Chandraprabha Vati - 50 gms,, Punar
Punarnavadi
mandoora - 50gms in equal quant
quantities.
Both the test drugs were prepa
epared at the
Pharmacy of S.V. Ayurveda Pha
Pharmacy, Tirupati.
5. Parameters
5.1.1. Subjective Parameters:
s: Assessment
of the therapy is done according
ng to the relief
observed in the signs and symptom
ptoms with the
help of scoring pattern whichh is prepared
according to classical Ayurveda
da aand modern
texts.
5.1.2Objective Parameters: Bas
ased on various investigations like urine,, bl
blood, biochemical examination, X-Ray (KUB
(KUB), USG
(KUB) are carried before and
nd after treat.[17]
ment
6. Inclusion Criteria
6.1. Age: Between 15 to 60 years
ars
6.2. Sex: Either sex
6.3. Radiological evidence of stone
tone (up to 10
mm) in Kidney, Ureter and Urina
inary Bladder.
7. Exclusion Criteria
7.1. Patients with age below
ow 15 years and
above 60 years.
7.2. Stone size more than 10 mm.
m.
7.3. Impacted stone.
7.4. Gross Hydronephrosis.
7.5. Pyelonephritis.
7.6. Uncontrolled Diabetic Mellit
llitus and Hypertension
7.7. Malignancy.
7.8. Impaired Renal Function.
32
www.iamj.in
ng Kidney.
7.9. Poorly Functioning
Kidne
ruction in urinary
7.10. Patients with obstruc
passage.
wn metabolic
abnor7.11. Patients with known
m
tion.
mality for calculus formation.
tion of calculus.
7.12. Any other complication
ng treatment
for any
7.13. Patients undergoing
tr
other serious illness.
8. Follow Up:
under this
All the patients who were studied
st
letion of treatment
clinical trial after completi
to have
for prescribed period weree instructed
ins
of 7 to 15
regular check up at the interval
inte
days for the period of 3 months
mont (90 days).
udy period patients
During this follow up study
hly for the recurwere examined thoroughly
rence of either signs and symptoms of
stones.
parameters
Statistical Analysis: Urinary
Urina
lyzed by Wilcoxon
and calculi size were analyz
ical parameters by
signed-rank test, biochemica
of calculi
paired-test and complete expulsion
expul
ues were expressed
by Fisher's exact test. Values
as mean ± SD for calculi size,
siz relief of clinind biochemical pacal symptoms, urine, and
xpulsion of renal
rameters. Complete expul
he incidence of ocstones was expressed as the
treated
currences in Ayurvedic formulation
form
vel of significance
groups. The minimum level
was fixed at p < 0.05.
howed that P-value of
Statistical analysis showed
less than 0.05 was seen in the first group
from 0 to 3 month. There was
wa no significant
ize within group II
difference in the stone size
when the 1st month and 3rd month visit was
t.
compared with initial visit.
RESULTS
• Out of 28 patients, 10 in each group
were completed the thera
herapy & follow up
period. So, in this study
udy, general observations were made on 20 patients as
mentioned in Table 1. Analytical
Ana
study
of both the drugs is ment
entioned in Table 2
and Results were made
de on
o 20 patients as
shown in Tables 3 to
o 4.
• Patient satisfaction: At 4 weeks of follow-up, all patients were
we asked to ex-
IAMJ: Volume 1; Issue 6; Nov Dec2013
Chakradhar K. V. & Dattatreya Rao. S to Evaluate the Potential of Yava Paneeya Kshara (Alkali Preparation of Barley) on
Nephrolithiasis A Pilot Study
press their degree of satisfaction about
treatment outcome in terms of 'cured' / '
markedly improved’ / ‘improved’
/'unchanged' / 'worsened'. In group I
(Yava Paneeya Kshara Group), 83.33%
patients reported as 'Cured' and 16.67%
as ' markedly improved ' while in group
II (GCP Compound Group), 66.67% patients reported as ‘improved’ and
33.37% as ‘unchanged’. This difference
of patient satisfaction was significant
statistically at P < 0.05 using Chi-square
test, with Group I patients reporting a
higher degree of satisfaction at 04
weeks.
• In group I, Statistically highly significance (P<0.001) is noted in the result
outcome of Nabhi vedana, Mutradharasanga and Atiavilamutratha while in
group II, Statistically highly significance
(P<0.001) is noted in the result outcome
of Basti Vedana (Bladder pain).
DISCUSSION
Urolithiasis is a complex process that results
from a succession of several physicochemical events including super saturation, nucleation, growth, aggregation and retention
within the kidneys. Treatment of urolithiasis
involves either conservative therapy or
interventional procedures. The primary
agents in medical management for urolithiasis, has been investigated with calcium
channel blockers, steroids, non-steroidal
anti-inflammatory drugs (NSAIDs), and α 1adrenergic receptor antagonists [18]. Although calcium channel blockers with or
without steroids and/or NSAIDs have shown
to be successful in the treatment, α -blockers,
with their high success rates have become
the leading candidate in medical therapy [19].
However, these treatment regimens are not
free from side effects. The endoscopic stone
management have allowed kidney stones to
be treated using minimally invasive techniques, which have increased success rates
and decreased treatment-related morbidity.
These advances include shock wave lithotripsy (SWL), ureteroscopy, and percuta-
33
www.iamj.in
neous nephrostolithotomy [6]. Although
these approaches are less invasive than the
traditional open surgical approaches, they
are expensive and have inherent risks .Due
to the high cost and adverse effects of minimally invasive techniques and recurrence,
alternative treatment modalities with phytotherapeutic agents have become the mainstay of medical therapy. In the present study,
an Ayurvedic formulation containing principal herbs useful in the treatment of urinary
calculi was evaluated for its safety and efficacy. Levels of urinary super-saturation correlate with the type of stone formed, and
lowering of super saturation is effective for
preventing stone recurrence and reduces the
relapse risk [3]. In vitro crystallization systems are widely used to study the processes
of crystal nucleation growth and agglomeration, which in turn helps in exploring the
patho-physiology of renal stone disease. In
vitro and in vivo studies on crystallization
showed an inhibition of the matrix bound
mineral phase formation and its subsequent
growth with the Yava Paneeya Kshara[20][21].
The findings of the study showed beneficial
effects of Ayurvedic formulation (Yava Paneeya Kshara) as revealed by the improvement of various clinical symptoms, increased stone expulsion rate and the time
required for expulsion as well as urine microscopy (WBC and RBC), which correlated
well with the experimental findings. The observed beneficial effects in the management
of urolithiasis following an Ayurvedic formulation treatment in this trial could be due
to the prevention of urinary supersaturation,
inhibition of mineralization of stone-forming
constituents, normalization of cellular function in renal oxidative stress, correction of
crystalloid-colloid balance as well as the
beneficial effects such as anti-inflammatory,
antimicrobial,
diuretic,
antispasmodic,
litholytic, and anticalcifying activities of individual ingredients.
Study involving larger population of patients
will be necessary to confirm the findings of
this study. Urolithiasis (Mutrashmari) in
IAMJ: Volume 1; Issue 6; Nov Dec2013
Chakradhar K. V. & Dattatreya Rao. S to Evaluate the Potential of Yava Paneeya Kshara (Alkali Preparation of Barley) on
Nephrolithiasis A Pilot Study
Ayurveda is described as a painful disease
which needs to be addressed early. In the
beginning stages, disease can be effectively
managed with medical intervention, while in
the later stages with enlarged stones, the
only successful measure would be lithotripsy. The medical management would
include the administration of lithotriptic
herbs and substances besides the measures
to manage the bio-energies that control the
disease manifestations. With this line of
treatment, Ayurveda envisages that the stone
forming substances are controlled, which
prevents recurrence of the stone.
Role of Yava Kshara
YAVA KSHARA -Alkali preparation of Barley
Latin name: Hordeum vulgare
Family: Gramineae
Properties:
• Rasa: Kaţ u
• Guņ a: Laghu, Snigdha
• Virya: Uşņ a
• Vipāka: Kaţ u
• Doşaghnatā: Kapha Vāta Śāmaka
Pharmacological Action: This drug is useful
in the pathogenesis like Amlapitta, Aśmari,
Mūtrakŗ ccra, Udaraśūla, Gulma, Arśa.
Chemical Constituents: The substance contains potassium chloride, potassium sulphate, potassium bicarbonate and potassium
carbonate.
Yava Kshara (Alkali preparation of Barley)
is having pH 11.73. Thus it helps to neutralize the acidic media and prevents stone
formation. As the Yava Kshara is alkaline in
nature which changes the pH of the urine,
this helps in preventing the hyper-concentration of the urine. As it changes the pH of
the urine by its alkali nature, it helps in the
dissolution of the calculi. Yava Kshara has
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34
www.iamj.in
undergone clinical trials that support its impact on Calcium Oxalate crystallisation.
Preliminary clinical trials have evaluated the
role of GCP Compound in the prevention of
Urolithiasis and as a method of stone expulsion, yet the treatment effect and mechanism
of action remains to be elucidated.
CONCLUSION
Haematological and biochemical investigations reveal that both groups having statistically non-significant effect on all the parameters. However, it was noticed that the
variation in all the parameters were observed
within normal range. Both the drugs were
found more effective on Vataja Ashmari
(Calcium Oxalate Stones), moderately effective on Pittaja Ashmari and least effective on Kaphaja Ashmari in the present
Clinical Study. Overall effect of therapy
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(Yava Paneeya Kshara) is safe and effective
in the treatment of urolithiasis, with significant improvement in symptoms associated
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Nephrolithiasis A Pilot Study
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Chakradhar K. V. & Dattatreya Rao. S to Evaluate the Potential of Yava Paneeya Kshara (Alkali Preparation of Barley) on
Nephrolithiasis A Pilot Study
juice, in the kidney of rats with nephrolithiasis induced by ethylene glycol. J EnTable 1:
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Group I
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Group II
Total
Registered
15
13
Completed
10
10
LAMA*
05
03
*LAMA – Left Against Medical Advice
Table 2: Analytical Study of the Drugs
Yava Paneeya Kshara
28
20
08
GCP Compound
Specific Gravity
1.019
1.016
pH
11.73
6.38
Table –3: Effect of therapy on clinical features (Acc. to Ayurveda) in 10 patients of Renal calculi
by using Yava Paneeya Kshara (Group – I: Experimental group):
Clinical features Mean
Mean
%
SD
SE
‘t’
P
B.T.
A.T.
Nabhivedana
2.20
1.00
54.55
0.78
0.25
4.80
< 0.001
Bastivedana
1.30
0.60
53.85
0.82
0.26
2.69
< 0.01
Sevanivedana
1.10
0.60
45.45
0.53
0.17
2.94
< 0.01
Mehanvedana
0.80
0.40
50.00
0.70
0.22
1.81
< 0.05
Mutradharasanga 2.10
1.10
47.62
0.66
0.21
4.76
< 0.001
Sarudhiramutrata 0.70
0.30
57.14
0.52
0.16
2.50
< 0.01
Gomedaprakasa 0.70
0.10
85.71
0.84
0.27
2.22
< 0.05
Atiavilamutrata
2.00
0.90
55.00
0.99
0.31
3.55
<0.001
Table –4: Effect of therapy on clinical features (Acc. to Ayurveda) of 10 patients of Renal calculi
by using GCP COMPOUND (Group – II: Control Group)
Clinical
Mean
Mean
%
S.D.
S.E.
‘t’
P
features
B.T.
A.T.
Nabhivedana
Bastivedana
Mehanvedana
Mutradharasang
Sarudhiramutrata
Gomedaprakasha
Atiavilamutrata
2.20
1.70
0.40
1.10
0.80
0.50
1.60
1.70
0.70
0.10
0.40
0.30
0.10
1.00
22.73
58.82
75.00
63.64
62.50
80.00
37.50
0.53
0.82
0.67
0.82
0.71
0.84
0.70
0.17
0.25
0.21
0.26
0.22
0.27
0.22
2.94
4.00
1.43
2.69
2.27
1.48
2.73
CORRESPONDING AUTHOR
Dr. Chakradhar K.V,
Final Year P.G. Scholar, P.G. Department of Shalya, S.V. Ayurvedic Medical College &
Hospital,SVIMS Road, Tirupati, Andhra Pradesh, India.
Source of support: Nil, Conflict of interest: None Declared
36
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IAMJ: Volume 1; Issue 6; Nov Dec2013
< 0.01
<0.001
<0.05
< 0.01
< 0.01
< 0.05
< 0.01
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