Issue : 01 DOI : 10.5281/zenodo.8147277
INTERNATIONAL
JOURNAL
OF
DIAGNOSTICS
AND
RESEARCH
Volume : 01
Copyright @ : - Dr. Subhash Waghe Inter. J.Digno. and Research IJDRMSID0007
Page 1
Corresponding author: Dr. Subhash Waghe
Article Info: Published on : 02 /01/2024
Abstract
Cirrhosis is a chronic liver disease in which there is necrosis of liver cells followed by fibrosis and nodule formation causing gross
derangement of the liver architecture. It is a leading cause of death due to complications associated with it like variceal bleeding,
encephalopathy and ascites. The major causes of cirrhosis of liver includes chronic viral infections with hepatitis B or C virus,
Chronic alcoholic liver disease, non-alcoholic fatty liver disease. It was associated with 2.4% of the global deaths in 2019
[1]
. In
Ayurveda syndrome of Cirrhosis of liver can be correlated to the disease Kumbhakamala. As per Acharya Charaka, the disease
Kumbhakamala is a complication of diseases Kamala (hepatocellular jaundice)
[3]
. The disease Kamala on chronicity or if left
untreated advances to the complicated stage called Kumbhakamala characterized by hematemesis, malena, ascites, edema,
anorexia, anemia, jaundice, drowsiness and coma. While, preparing the diagnostic criteria, the features mentioned in both
Ayurvedic as well as modern science were considered. Drugs like Guduchi, Daruharidra, Bhumyamalki, Ashwagandha
Punarnawa, Katuki, and Arjuna have hepatoprotective activities. Katuki act as cholagogue. Guduchi, Daruharidra and
Bhumyamalki, acts as antiviral. Ashwagandha and Arjuna acts as hepatoprotective. Punanava acts as diuretic and anti-
inflammatory. Considering their pharmacological profile, they were selected for making the unified herbo-mineral compound
Sidoliv. Patients having history of prolonged intake of alcohol or chronic infection with HBV or HCV having features of Cirrhosis
of liver supported with pathological and sonological findings were selected for the study from OPD and IPD sections of Pakwasa
Samnvaya Rugnalaya and all India Ayurveda Research Institute, Hanuman-nagar Nagpur. Two capsules were given with plain
water twice a day for 45 days. The capsules were provided by Shree Baidynath Bhavan, Nagpur. Three follow ups were taken at
the interval of 15 days. Investigations were done before and after the trial. Non parametric tests like Npar test and Wilcoxon
Signed Rank tests were applied to assess the result in clinical features where severity of these features was graded in the score
between 0 to 3 and where such severity gradation was not possible, McNemar test was applied for assessment of the response to
the drug therapy. It is observed and concluded that the present randomized clinical trial does not show any significant
improvement with regard to clinical features or pathological parameters.
Keywords: Kumbhakamala, Cirrhosis
P
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INTERNATIONAL JOURNAL OF DIAGNOSTICS AND RESEARCH
Evaluation of Herbo - mineral compound ‘Sidoliv’ in the treatment of Cirrhosis of
Liver w.s.r. to Disease ‘Kumbhakamala’ in Ayurveda
Dr. Subhash D. Waghe
1
1
Professor & HOD – Dept. of Roganidana
Sarvapalli Radhakrishna Ayurveda College & Research Center, Bhopal
Cite this article as: - Dr. Subhash Waghe (2024) ;Evaluation of Herbo - mineral compound ‘Sidoliv’ in the treatment of Cirrhosis of
Liver w.s.r. to Disease ‘Kumbhakamala’ in Ayurveda ; Inter.J.Dignostics and Research 1(2) 1-6, https:/doi.org
/10.5281/zenodo.10451114
Review Of Literature:
Cirrhosis is a chronic condition of liver disease in
which there is necrosis of liver tissue followed by
fibrosis and nodule formation
[2]
. In Ayurveda
syndrome of Cirrhosis of liver can be correlated to
the disease Kumbhakamala. As per Acharya Charaka,
the disease Kumbhakamala is a complication of
disease Kamala (hepatocellular jaundice)
[3]
. The
disease Kamala on chronicity or if left untreated
advances to the complicated stage called
Kumbhakamala characterized by hematemesis,
malena, ascites, oedema, anorexia, anemia, jaundice,
drowsiness and coma. The development of features
like hematemesis, melena, ascites, and splenomegaly
indicates portal hypertension. The development of
G
A
R
V
Issue : 02
INTERNATIONAL JOURNAL OF DIAGNOSTICS AND RESEARCH
Volume : 01
Copyright @ : - Dr. Subhash Waghe Inter. J.Digno. and Research IJDRMSID0007
Page 2
features like drowsiness and coma indicated
encephalopathy. The development of dyspnea may
occur due to hepato pulmonary syndrome. Drugs like
Guduchi (tinospora cardiofolia), Daruharidra
(Barberis aristata), Bhumyamalki (Phylantrhus
amarus), Ashwagandha (Withania somnifera)
Punarnawa (Boerrhavia difusa), Katuki (Picrorhiza
kuroa), Arjun (Termanalia arjuna) have
hepatoprotective activities. Drugs like Katuki act as
cholagogue. Guduchi, Daruharidra, Bhumyamalki,
acts as antiviral. Ashwagandha and Arjuna acts as
hepatoprotective. Punanava acts as diuretic and anti-
inflammatory. Considering their pharmacological
profile, they were selected for making the unified
herbo-mineral compound Sidoliv.
Material & Method:
Selection of Patients & Place of Study
Patients having clinical features of Cirrhosis of liver
supported with laboratory findings were selected
without any prejudice from OPD and IPD sections of
Pakwasa Samnvaya Rugnalaya and all India
Ayurveda Research Institute, Hanuman-nagar,
Nagpur.
Diagnostic and Selection criteria
Patients having history of prolonged intake of alcohol
or chronic infection with HBV or HCV having
features of Cirrhosis of liver supported with
pathological and sonological findings were selected
for the study.
Clinical Trial
A randomized clinical trial of herbo-mineral
compound (Sidoliv capsule) comprising of extracts of
Guduchi, Daruharidra, Bhumyamalki, Ashwagandha
Punarnawa, Katuki, Arjun and powder of
Shwetparpati was administered to 10 diagnosed
patients of Cirrhosis of liver in the capsule form. Two
capsules were given with plain water twice a day for
45 days. The capsules were provided by Shree
Baidynath Bhavan, Nagpur. Three follow ups were
taken at the interval of 15 days. Investigations were
done before and after the trial. Response to therapy
was assessed with respect to clinical features and
pathological findings.
Statistical Evaluation:
Non parametric tests like Npar test and Wilcoxon
Signed Rank tests were applied to assess the result in
clinical features where severity of these features was
graded in the
score between 0 to 3 and where such severity
gradation was not possible, McNemar test was
applied for assessment of the response to the drug
therapy
Observations:
Table No. 1 [n = 10] (Npar Test)
Sr.
Clinical
Feature
Mean
BT
Mean
AT
SD -
BT
SD –
AT
1
Aruchi
1.6000
0.8000
0.9661
1.0328
2
Avipaka
1.4000
0.9000
0.9661
0.9944
3
Nashtagni
1.5000
0.8000
0.9718
1.0328
4
Anaha
2.1000
1.3000
0.5676
0.6749
5
Udaradhman
2.2000
1.3000
0.4216
0.8233
6
Daurbalya
2.2000
2.1000
0.7888
0.7379
7
Sadanam
2.2000
2.0000
0.7888
0.8165
8
Hatendriyata
1.9000
1.6000
1.1005
1.2649
9
Karshan
2.2000
2.1000
1.0328
1.1972
10
Daha
0.1000
0.0000
0.3162
0.0000
11
Trishna
0.1000
0.1000
0.3162
0.3162
12
Haridra
Netrata
0.2000
0.0000
0.4216
0.0000
13
Jwara
0.2000
0.0000
0.4216
0.0000
14
Tamyata
0.5000
0.1000
0.7071
0.3162
15
Yakrit
Vriddhi
0.3000
0.2000
0.4830
0.4216
16
Pleeha
Vriddhi
0.6000
0.5000
1.0750
0.8498
17
Jalodara
2.4000
0.5000
0.6992
0.8498
18
Shoona
1.8000
1.0000
0.7888
0.8165
19
Sarakta
Chhardi
0.0000
0.2000
0.0000
0.6325
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Page 3
Table No. 2 [n = 10] (Wilcoxon Signed Rank Test)
Sr.
Clinical Feature
Z
Two tailed
1
Aruchi
- 2.271a
0.023
2
Avipaka
- 1.890a
0.059
3
Nashtagni
- 2.333a
0.020
4
Anaha
- 2. 530a
0.011
5
Udaradhman
- 2.460a
0.014
6
Daurbalya
- 1.000a
0.317
7
Sadanam
- 1.414a
0.157
8
Hatendriyata
- 1.3421
0.180
9
Karshan
- 1.000a
0.317
10
Daha
- 1.000a
0.317
11
Trishna
- 0.000b
1.000
12
Haridra Netrata
- 1.414a
0.157
13
Jwara
- 1.414a
0.157
14
Tamyata
- 2.000a
0.046
15
Yakrit Vriddhi
- 1.000a
0.317
16
Pleeha Vriddhi
- 0.577a
0.564
17
Jalodara
- 2.714a
0.007
18
Shoona
- 2.530a
0.011
19
Sarakta Chhardi
- 1.000c
0.317
Descriptive Statistics :
Features where gradation of severity was not
possible, were arranged by using Npar test and its
result after treatment was assessed by applying
McNemar test.
Table No. 3 [n = 10]
Sr.
Clinical
Feature
Mean
BT
Mean
AT
SD (BT)
SD
(AT)
1
Gynaeco-
mastia
0.4000
0.4000
0.5164
0.5164
2
Testicular
Atrophy
0.1000
0.9000
0.3162
0.3162
3
Dupytren’s
contracture
0.2000
0.2000
0.4216
0.4216
4
Loss of
libido
0.8000
0.8000
0.4216
0.4216
5
Dilated veins
on abdomen
0.6000
0.3000
0.5164
0.4830
Test Statistics (McNemar Test) :
Table No. 4 [n = 10]
Sr.
Clinical Feature
Exact Sig.
(2-tailed)
1
Gynaeco-mastia
0.250a
2
Testicular Atrophy
1.000a
3
Dupytren’s contracture
1.000a
4
Loss of libido
1.000a
5
Dilated veins on abdomen
1.000a
Table No. 5 – Clinical Features outcome
Sr.
Clinical
Feature
Cured
Improved
Unchanged
1
Aruchi
-
10
-
2
Avipaka
-
-
10
3
Nashtagni
-
10
-
4
Anaha
-
10
-
5
Udaradhman
-
10
-
6
Daurbalya
-
-
10
7
Sadanam
-
-
10
8
Hatendriyata
-
-
10
9
Karshan
-
-
10
10
Daha
-
-
10
11
Trishna
-
-
10
12
Haridra
Netrata
-
-
10
13
Jwara
-
-
10
14
Tamyata
-
10
-
15
Yakrit Vriddhi
-
-
10
16
Pleeha Vriddhi
-
-
10
17
Jalodara
-
10
-
18
Shoona
-
10
-
19
Sarakta
Chhardi
-
-
10
20
Gynaeco-
mastia
-
-
10
21
Testicular
Atrophy
-
-
10
22
Dupytren’s
contracture
-
-
10
23
Loss of libido
-
-
10
24
Dilated veins
on abdomen
-
-
10
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Paired T test was used to assess the response to the
drug therapy with respect to the pathological
investigations.
Table no. 6 [n = 10] - pathological investigations
(Paired t test)
S
r.
Clinical
Feature
Mea
n
(BT)
Mea
n
(AT)
SD
(BT)
SD
(AT)
SE
(BT)
SE
(AT)
1
Sr.
Bilirubi
n (T)
1.740
0
1.720
0
0.52
32
0.43
92
0.16
55
0.13
89
2
Sr.
Bilirubi
n (D)
1.010
0
0.980
0
0.40
67
0.18
74
0.12
86
5.92
5
3
Sr.
Bilirubi
n (I)
0.730
0
0.740
0
0.59
08
0.55
62
0.18
68
0.17
59
4
Sr. AST
67.40
00
56.70
00
44.2
925
36.9
115
14.0
065
11.6
724
5
Sr. ALT
45.90
00
50.30
00
26.7
226
33.4
466
8.45
04
10.5
768
6
Sr.
Albumi
n
2.730
0
2.920
0
0.37
73
0.38
53
0.11
93
0.12
18
7
Sr.
Prothro
mbin
Time
Index
73.91
50
76.91
40
11.7
242
6.06
14
3.70
75
1.91
68
8
Sr.
Prothro
mbin
Differen
ce (P-C)
4.740
0
4.020
0
2.48
29
1.55
83
0.78
52
0.49
28
9
Sr.
Sodium
139.7
000
126.8
000
8.19
28
30.4
624
2.59
08
9.63
30
1
0
Hemogl
obin
10.32
00
10.28
00
1.31
61
0.60
52
0.35
93
0.19
14
Table no. 7 - Paired Sample Test
Pair
BT - AT
Probabi
lity
Mea
n
SD
SE
95%
Confidence
Interval of
the difference
Lowe
r
Uppe
r
Sr.
Bilirubin
(T)
2.000
E-02
0.315
5
9.978
E-02
-
0.205
7
0.245
7
0.200
Sr.
Bilirubin
(D)
3.000
E-02
0.333
5
0.105
5
-
0.208
6
0.268
6
0.284
Sr.
Bilirubin
(I)
-1.00
E-02
0.119
7
3.788
6
E-02
-9.56
E-02
7.564
E-02
-0. 264
Sr. AST
10.70
00
32.89
06
10.40
09
-
12.82
85
34.22
85
1.029
Sr. ALT
-
4.400
0
22.26
71
7.041
5
-
20.32
89
11.52
89
- 0.625
Sr.
Albumin
-
0.190
0
0.435
8
0.137
8
-
0.501
7
-
20.32
89
- 0.625
Sr.
Prothro
mbin
Time
Index
-
2.999
0
14.53
70
4.597
0
-
13.39
82
7.400
2
-0.652
Sr.
Prothro
mbin
Differen
ce (P-C)
0.720
0
3.296
4
1.042
4
-
1.638
1
3.078
1
0.691
Sr.
Sodium
12.90
00
28.05
33
8.871
2
-
7.168
1
32.96
81
1.454
Hemoglo
bin
4.000
E -02
0.602
2
0.190
4
-
0.390
8
0.470
8
0.210
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Table No. 8 - Paired Sample Test Data Analysis
Sr.
Pair (BT -AT)
Df
Sig.
(2 tailed)
1
Sr. Bilirubin (T)
9
0.846
2
Sr. Bilirubin (D)
9
0.782
3
Sr. Bilirubin (I)
9
0.798
4
Sr. AST
9
0.330
5
Sr. ALT
9
0.548
6
Sr. Albumin
9
0.201
7
Sr. Prothrombin Time
Index
9
0.530
8
Sr. Prothrombin Difference
(P-C)
9
0.507
9
Sr. Sodium
9
0.180
10
Hemoglobin
9
0.838
Table No. 9 - Pathological Results of Clinical Trial
Sr.
Clinical
Feature
Cured
Improved
Unchanged
1
Sr. Bilirubin
(T)
--
--
10
2
Sr. Bilirubin
(D)
--
--
10
3
Sr. Bilirubin
(I)
--
--
10
4
Sr. AST
--
--
10
5
Sr. ALT
--
--
10
6
Sr. Albumin
--
--
10
7
Sr.
Prothrombin
Time Index
--
--
10
8
Sr.
Prothrombin
Difference (P-
C)
--
--
10
9
Sr. Sodium
--
--
10
10
Hemoglobin
--
--
10
Since the value of the signed (2 tailed) test is not
having the probability < 0.05, it is concluded that
pathologically no significant response was observed
after treatment with the trial drug in any of the
pathological investigation.
Discussion:
The clinical trial of herbo-mineral compound
(Sidoliv) comprising of extracts of Guduchi,
Daruharidra, Bhumyamalki, Ashwagandha
Punarnawa, Katuki, Arjun and powder of
Shwetparpati was conducted in 10 patients of
Cirrhosis of liver. Out of 10 patients, 9 were male
and 1 patient was female. 90% of the patients were in
the age group between 40-60 years and 10% patients
were between 60-80 years. Alcohol was directly
responsible for development of cirrhosis in 70%
cases. HBV infection in 20% and HCV in 10%
patients. Non parametric tests like Npar and
Wilcoxon Signed Rank tests were applied to assess
the results in clinical features. Severity of the features
were graded in the score between 0-3. The features
like gynaecomastia, testicular atrophy, Dupyutren’s
contractures, loss of libido, dilated veins where
gradation of severity was not possible, other non-
parametric test like McNemar test was applied.
Features of encephalopathy were absent in this group.
The urine, stool was normal. Hematemesis and
malena was absent. Paired T test was applied to
assess the result of therapy with respect to
pathological investigations. Findings showing
probability < 0.05 were considered significant.
Significant symptomatic relief was observed after
treatment in only seven features like malaise,
anorexia, constipation syndrome, abdominal
distension, ascites, and edema feet out of total 24
features. No significant change was seen in
pathological findings before and after treatment.
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Conclusion:
Since the value of the signed (2 tailed) test is not
having the probability < 0.05, it is concluded that
pathologically no significant response was observed
after treatment with the trial drug sidoliv in any of the
pathological investigation or clinical features. This is
a study on small sample in limited time. Further
study can be conducted on larger sample at bigger
institute.
References:
1. https:// www.who.int/data/ gho/ data/
themes/mortality-and-global-health-
estimates/ghe-leading-causes-of death. (2023)
2. Praveen Kumar and Michael Clark, Clinical
Medicine’ chapter 23,9
th
edition, published
by Elsevier Ltd., 2017 : 465-473
3. Vidyadhar Shukla, Ravidutta Tripathi,
‘Charak samhita’ of acharya Charak and
Agnivesha, Chikitsasthana 16/34-38 , hindi
translation, 1
st
edition, Vol. 1, published by
Chaukhamba Sanskrit Pratishthan, 4360/4,
ansari road, Daryaganj, New Delhi – 110 002,
2019, pg. 395-415
xxxx-xxxx
DOI : 10.5281/zenodo.10451114
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