Shilajit: evalution of its effects on blood chemistry of normal human subjects

Abstract

The effect of Shilajit on blood chemistry was studied in normal human volunteers. Administration of two gms of Shilajit for 45 days did not produced any significant change in physical parameters i.e. blood pressure, pulse rate and body weight and similarly no charge was observed in hematological parameters. A signification reduction in Serum Triglycerides, Serum cholesterol with simultaneous improvement in HDL Cholesterol was seen, besides Shilajit also improved antioxidant status of volunteers. Results of study suggest hypolipidemic and strong antioxidant activity of Shilajit.

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Ancient Science of Life Vol : XXIII(2) October, November, December 2003 3DJHV
SHILAJIT: EVALUTION OF ITS EFFECTS ON BLOOD
CHEMISTRY OF NORMAL HUMAN SUBJECTS
Pravenn Sharma1, Jagrati Jha1, V. Shrinivas2, L.K. Dwivedi2,
P. Suresh2 and M. Sinha1
1Department of Biochemistry, SMS Medical College, Jaipur – 302 004.
2National Institute of Ayurveda, Jaipur – 302 004.
Received : 03-02-2003 Accepted: 26-08-2003
ABSTRACT: The effect of Shilajit on blood chemistry was studied in normal human volunteers.
Administration of two gms of Shilajit for 45 days did not produced any significant change in
physical parameters i.e. blood pressure, pulse rate and body weight and similarly no charge was
observed in hematological parameters. A signification reduction in Serum Triglycerides, Serum
cholesterol with simultaneous improvement in HDL Cholesterol was seen, besides Shilajit also
improved antioxidant status of volunteers. Results of study suggest hypolipidemic and strong
antioxidant activity of Shilajit.
INTRODUCTION:
Shilajit is a bituminous substance which is
compact mass of vegetables matter composed
of dark, red, gummy matrix interspersed with
vegetable fibres, sand and earthy matter (1).
In ‘folklore’ medicine Shilajit has been
implicated in several clinical conditions and is
being prescribed by Ayurvedic physicians for
the treatment of diabetes, jaundice, gall
bladder disease and renal calculi, enlarged
spleen, digestive troubles, fermentative
dyspepsia, adiposity, anasarca, anuri, hysteria,
neurological diseases, amenorrhoea,
dysmenorrhoea and menorrhagia, genitor –
urinary diseases, tuberculosis, leprosy,
eczema, anemia, anorexia, chronic bronchitis,
asthma, fracture of bones and many other
clinical conditions. It has also been claimed
that “There is hardly any curable diseases
which cannot be controlled / cured with the
aid of Shilajit” (2,3,4) Survey of literatures
reveals that there are only a few studies which
have been carried out systematically to
understand therapeutic and biological action
of Shilajit. Aqueous suspension of Shilajit
has been found to have analgesic and anti –
inflammatory activity without any toxic effect
given in dose of 1 gm./kg body weight to
albino mice (5). More recently researchers
have indicated antistress and adaptogenic (6)
and antioxidant action of Shilajit (7).
Ghoshal and Bhattacharya (1996) reported
that processed Shilajit provides significant
antioxidants defence as compared to native
Shilajit, which has weak antioxidant action
(8). Various Therapeutic actions of Shilajit
have been attributed to its active principles
fulvic acid and dialphabenzopyrones.
Although Shilajit has been claimed to cure
several diseases, its effect on blood chemistry,
organ functions and antioxidant action has not
been examined in vivo, hence the present
study is an attempt to examine the effect of
Shilajit on blood chemistry of normal human
subjects.
MATERIALS AND METHODS
30 medical students from National Institution
of Ayurveda, Jaipur participated in the present
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study ranging in age from 16 to 30 years. A
written consent was obtained from each of
them and they were appraised of the purpose
of study. Care was taken to ensure that all the
subjects were from similar socioeconomic
status, symptom free, without any obvious
clinical disorder on examination, not taking
any drug therapy, vitamins and health booster,
non smokers and lacto vegetarian and non
pregnant. Subjects were administered with 2
gms Shilajit per day in the form of capsules of
500 mg. each.
Crude Shilajit was procured from Pharmacy
of National Institute of Ayurveda, Jaipur, and
purified by one of us (V.S) who is an
Ayurvedic Physician himself by “Agnitapi”
method. (9, 10) Purification of Shilajit by
Agnitapi method essentially involves four
steps. 1. Soaking in water/preparation of
solution of Shilajit. 2. Filteration – to remove
impurities and practicles. 3. Boiling of clear
watery filtrate until a thick viscous liquid is
obtained. 4. Drying of thick viscous liquid
obtained in preceding step in incubator at
500C. The purity of processed Shilajit so
obtained was assessed by Ayurvedic method-
“Jalapariksha” and “Agnipariksha”. Shilajit
has a characteristic solubility, shape, from and
smoke. Capsules of 500 mg. of processed
and purified Shilajit were prepared.
Processed Shilajit was analyzed at Dabur
Research Foundation for its active principles.
Figure 1 shows fingerprints of purified
Shilajit relation to standard. Its chemical
analysis is given in Table 1. All the subjects
were clinically examined by one of us (V.S)
and their body weight, pulse rate, blood
pressure and history of any past illness were
carefully recorded. Double blind placebo
study was carried out and 20 subjects were
administered with two grams Shilajit per day
(4 capsules of 500 mg. each) under the
supervision of Ayurvedic physician and 10
subjects were given sugar capsules (placebo).
Subjects were unaware of the contents of
capsule.
Blood samples were drawn before and after
45 days of supplemention of Shilajit and
analyzed of Sugar, Urea, Creatinine, Total
Protein, Albumin, A/G Ration, Uric Acid,
SGOT, SGPT, Alkaline Phosphatase,
Triglycerides (TG), Cholesterol, HDL, LDL
and VLDL on Merck selectra auto analyzer
using standard kits. SOD was analysed by
kits supplied by Randox, Vitamin C and E
analysed by manual methods (11,12)
RESULTS AND DISCUSSION
Study was conducted on 30 normal healthy
human subjects in the age range 16-30 years.
Median age 24 years, out of which 20
subjects were given 2 gms of purified Shilajit
and 10 were placebo controls. Processed
Shilajit was procured from crude (native)
Shilajit through several steps of purification.
Native Shilajit is found to be contaminated
with polymeric quinines, microbial debris and
heavy metals (13, 14). These contaminants
are required to be removed by purification.
Purified Shilajit improves its beneficial
effects in living system. (Ghosal and
Bhattacharya 1996).
Processed Shilajit was found to be positive for
benzopyrones and fulvic acid contents, which
are considered as its active principles.
Purified Shilajit, used in present study
contains 6.61% (w/w) fulvic acid (Table 1).
Supplementation of 2 gms Shilajit for 45 days
to normal healthy subjects did not produce
any significant change in blood pressure,
pulse rate and body weight. Similarly no
change in hemoglobin level and cell counts
could be appreciated. Effect of processed
Shilajit on biochemical parameters is
summarized in Table 2, which shows that it
has no significant (p>0.05) effect on blood
sugar, urea, creatinine, uric acid, total protein,
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albumin, SGOT, SGPT and Alkaline
Phosphatase level. It has to be borne in mind
that the study was conducted in normal
conditions in normal subjects and most of the
drugs do not affect biochemical parameters in
normal conditions. But an important
observation emerges from this study that
Shilajit does not adversely affect liver and
kidney functions, which is evident from
SGOT, SGPT, Alkaline phosphatase, Urea,
Creatine and Uric acid levels. However at the
same time there was a significant reduction in
serum TG, Cholesterol, LDL Cholesterol and
VLDL Cholesterol levels and significant
improvement in HDL Cholesterol level.
Decrease in serum TG and Cholesterol level
(p<0.01) with simultaneous increase in HDL
suggests its hypolipidemic and cardio
protective activity. Further more its effects on
serum SOD; Vitamin E and Vitamin C have
also been examined. SOD is one of the
important antioxidant enzymes, which
removes the super oxide radical in the front
line of defense against oxidative stress, while
vitamin C and E are important nutrient
antioxidants, which prevent lipid per
oxidation. Shilajit significantly increased
SOD, Vitamin E and Vitamin C levels of
blood (p<0.01). Increase in antioxidant level
suggests its sparing effect on antioxidants and
strengthens the protective system to prevent
damages caused by reactive oxygen species
and also against the oxidative stress.
Antioxidant activity of Shilajit could be
attributed to its fulvic acid contents. Fulvic
acid plays as a bi-directional super
antioxidant i.e. as electron donors and
acceptors, depending upon the need for
balance in the situation. If it encounters free
radicals with unpaired positive electron it
supplies an equal and opposite negative
charge to neutralize it, likewise, if free
radicals carry a negative charge, the fulvic
acid molecule can supply positive unpaired
electron to nullify that charge. Ghosal and
Bhattacharya (1996) has also, observed in an
in vitro study that processed Shilajit provides
a significant oxidative defense by scavenging
singlet oxygen (8). Result of the study
suggests that Shilajit has hypolipidemic and
antioxidant action. However that extracts
mechanism of action is not yet fully
understood and further study is needed to
examine its effects in particular diseases,
which alter these biochemical parameters.
Bibliography:
1. Chopra R.N., Chopra I.C., Handa, K.L and Kapoor, L.D Indigenous drugs of India : Dhar &
Sons Pvt. Ltd., Calcutta 2nd Edition (1973).
2. Nadkarni, Indian Materica Media, 2:23-32, 1993.
3. Charaka Samhita Chikitsa Stana Chowkambha Orientalia, E:25-26, 1996.
4. Pandit Vishwanath, Bhavapraksha Nighnathu, Monthil Banarasidas Publication, 370, 1998.
5. Goshal S., Phytother. Res., 2(4), 187, 1988.
6. Bhattacharya S.K., Sen A.P. and Goshal S. Phytother. Res., 8, 1-4, 1994.
7. Goshal S., Mukharjee B and Bhattacharya S.K. Ind J. Indg. Med., 17(1), 1-11, 1995.
Pages 114 - 119

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8. Goshal S. and Bhattacharya S.K. Indian Journal of chemistry vol. 35 B, 127-132, 1996.
9. Damodar Joshi, Rasamitram, Ed. 1.257-262, 1998.
10. Rasatantra Sara and Siddha Prayoga Samgraha Publication Krishnan Gopal Kaleda, Ajmer,
part 1. Ed. 9th, 63-64, 1961.
11. Natelson S: Serum ascorbic acid estimation using dinitro phenyl hydrazine. In Techniques
of Clinical Chemistry, Springfield, Charles C Thomas 162, 1971.
12. Baker, H and Frand O, in Clinical vitaminology, methods and interpretation, Interscience
publisher. John Wiley and Sons Inc. New York. P. 172, 1968.
13. Goshal S, Pure and Appl Chem (IUPAC), 62, 1285, 1990.
14. Goshal S, Traditional medicine, edited by B. Mukharjee (Oxford – IBH, New Delhi), 308,
1993.
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TABLE 1
Analysis of Drug (Shilajit)
Dabur Research Foundation Analytical Report – No _ 050622
TEST Description SAMPLE
(PURIFIED)
Dark brown powder
Positive
Identification
Test for Benzopyrones
Test for Fulvic acids Positive
PH. 10% w/v Aq. Dispersion 6.37
Moisture content (KF) (%w/w) 9.50
Water soluble extractive value (%w/w) 92.13
Total ash content (%w/w) 15.35
Acid insoluble ash content (%w/w) 1.25
Assay as crude Fulvic Acid (%w/w) 6.61
Table 2
Effect of Shilajit on blood chemistry (Values are Mean ± SD)
Group 1
(Placebo)
n = 10
(without supplementation)
Group 2
n = 20
(Supplementation of
Shilajit)
S.
NO PARAMETER
Before After Before After
01
02
03
04
05
06
SUGAR (mg/dl)
UREA (mg/dl)
CREATININE (mg/dl)
URIC ACID (mg/dl)
TOTAL PROTEIN (g/dl)
ALBUMIN (g/dl)
76.3 ± 8.28
24.0 ± 3.68
1.0 ± 0.118
4.67 ± 1.06
7.09 ± 0.27
3.97 ± 0.24
76.1 ± 7.85
22.8 ± 5.05
0.97 ± 0.11
4.55 ± 1.11
6.99 ± 0.30
3.90 ± 0.18
79.3 ± 8.00
26.5 ± 6.00
0.99 ± 0.13
4.6 ± 0.65
7.05 ± 0.35
3.95 ± 0.201
75.8 ± 7.18
24.1 ± 5.70
0.96 ± 0.22
4.3 ± 0.65
7.1 ± 0.237
4.00± 0.087
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07
08
09
10
11
12
13
14
15
16
17
18
A/G RATIO
SGOT (U/L)
SGPT (U/L)
ALK. PHOSPHATASE (U/L)
TRIGLYCERIDES (mg/dl)
CHOLESTEROL (mg/dl)
HDL (mg/dl)
LDL (mg/dl)
VLDL (mg/dl)
SOD (U/L)
VIT C (mg/dl)
VIT E (mg/dl)
1.26 ± 0.06
29.4 ± 6.03
19.7 ± 2.10
154.9±32.7
114.1±40.19
142.9±13.92
41.57 ± 1.38
78.55 ± 7.37
22.83 ± 7.99
186.5±37.07
0.71 ± 0.08
0.98 ± 0.09
1.22 ± 0.10
28.4 ± 5.64
20.4 ± 2.57
153.4 ± 34.7
115.6±40.76
142.3±12.78
41.4 ± 2.24
77.77 ± 6.25
23.13 ± 8.15
188.9±35.79
0.75 ± 0.09
1.03 ± 0.11
1.21 ± 0.083
32.2 ± 6.12
20.8 ± 3.02
160.1 ± 22.9
116.9 ± 24.6
145.3±15.33
41.2 ± 2.30
81.8 ± 8.11
23.30 ± 4.92
160.5±13.2
0.72 ± 0.09
0.95 ± 0.11
1.25± 0.102
28.7 ± 7.81
19.3 ± 2.49
151.6±26.32
92.7±39.12*
125.1±17.17*
43.6 ± 1.99*
63.30 ± 7.36 *
18.50 ± 7.82*
200.7±2.81*
0.99 ± 0.09*
1.28 ± 0.13 *
Statistical comparison was done before and after values: *p<0.01; rest not signature p>0.05.
Pages 114 - 119