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Sustainable Effect of Ayurvedic Formulations in the Treatment of Nutritional Anemia in Adolescent Students

Authors:
  • VCP Cancer Research Foundation
  • Skyline University Nigeria Kano Nigeria

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Anemia is a serious health problem in Indian school children. High prevalence of anemia has been reported in nonpregnant adolescent girls. An investigation was initiated to study the effect of two non-iron-containing Ayurvedic preparations-Sootshekhar Rasa plus Sitopaladi Churna-in improving nutritional anemia among adolescent students. This was a single-blinded, randomized, controlled study. The study setting was Dehradun district, North India. The subjects comprised a total of 1646 boys and girls, aged 11-18 years, attending school in Dehradun district. As per World Health Organization guidelines, a total of 1322 adolescent anemic students were randomly divided into 5 groups. Students of group I (control) received starch. Group II, III, and IV students received Sootshekhar Rasa (SR) plus Sitopaladi Churna (SC) in various combinations, namely, SR 125 mg + SC 500 mg daily, SR 250 mg + SC 400 mg daily, and SR 250 mg + SC 400 mg weekly, respectively. Group V student were given iron and folic acid tablet. All the students received treatment for 90 days and were followed up for the next 180 days. The outcome measure was to evaluate the effect of Sootshekhar Rasa plus Sitopaladi Churna in improving nutritional anemia. The overall prevalence of anemia was found to be 81.3%. At baseline, the mean hemoglobin (Hb) was 97.4 +/- 13.2 g/L and ranged from 96.4 +/- 0.8 g/L to 98.3 +/- 0.8 g/L in various groups. At end of follow-up (day 270), a significant increase in Hb levels from baseline was observed in all treatment groups; however, the Hb gain (6.9 +/- 0.6 g/L) in group III and group V (3.64 +/- 0.56 g/L) differed significantly from the control group. A total of 155 students dropped out of the study due to various reasons not related to treatment. No adverse side-effect of Ayurvedic medication was noted in any student. We conclude that a daily dose of Sootshekhar Rasa (250 mg) plus Sitopaladi Churna (400 mg) can produce sustainable improvement of nutritional anemia in adolescent students.
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Sustainable Effect of Ayurvedic Formulations
in the Treatment of Nutritional Anemia
in Adolescent Students
Vaidya Balendu Prakash, B.Sc., B.A.M.S.,
1,2
Shyam Prakash, Ph.D.,
3
Rajesh Sharma, M.Sc.,
1
and Sanjoy K. Pal, Ph.D.
2
Abstract
Objectives: Anemia is a serious health problem in Indian school children. High prevalence of anemia has been
reported in nonpregnant adolescent girls. An investigation was initiated to study the effect of two non-iron-
containing Ayurvedic preparations—Sootshekhar Rasa plus Sitopaladi Churna—in improving nutritional anemia
among adolescent students.
Design: This was a single-blinded, randomized, controlled study.
Setting: The study setting was Dehradun district, North India.
Subjects: The subjects comprised a total of 1646 boys and girls, aged 11–18 years, attending school in Dehradun
district.
Intervention: As per World Health Organization guidelines, a total of 1322 adolescent anemic students were
randomly divided into 5 groups. Students of group I (control) received starch. Group II, III, and IV students
received Sootshekhar Rasa (SR) plus Sitopaladi Churna (SC) in various combinations, namely, SR 125 mg þSC
500 mg daily, SR 250 mg þSC 400 mg daily, and SR 250 mg þSC 400 mg weekly, respectively. Group V student
were given iron and folic acid tablet. All the students received treatment for 90 days and were followed up for
the next 180 days.
Outcome measure: The outcome measure was to evaluate the effect of Sootshekhar Rasa plus Sitopaladi Churna in
improving nutritional anemia.
Results: The overall prevalence of anemia was found to be 81.3%. At baseline, the mean hemoglobin (Hb) was
97.4 13.2 g=L and ranged from 96.4 0.8 g=L to 98.3 0.8 g=L in various groups. At end of follow-up (day 270),
a significant increase in Hb levels from baseline was observed in all treatment groups; however, the Hb gain
(6.9 0.6 g=L) in group III and group V (3.64 0.56 g=L) differed significantly from the control group. A total of
155 students dropped out of the study due to various reasons not related to treatment. No adverse side-effect of
Ayurvedic medication was noted in any student.
Conclusions: We conclude that a daily dose of Sootshekhar Rasa (250 mg) plus Sitopaladi Churna (400 mg) can
produce sustainable improvement of nutritional anemia in adolescent students.
Introduction
Anemia is the most prevalent nutritional problem in
the world.
1
More than 2.1 billion people are anemic
worldwide.
2,3
Nutritional anemia, according to the World
Health Organization (WHO), is a state in which the hemo-
globin concentration in the blood is lower for the age, gender,
physiologic state, and altitude, as a consequence of shortage
of essential nutrients, independent of the cause of this
deficiency.
4,5
Nutritional anemia includes a lack of nutrients
such as iron, folic acid, vitamin B
12
and copper, and vitamins
C, E, and A. Iron deficiency anemia is the most prevalent form
of nutritional disorder in infancy. It also affects communities
not only in developing nations but also in highly industrialized
countries.
6
In the developing world, 42% of children less than
5 years of age and 53% of children 5–14 years of age are anemic.
7
Anemia is a serious public health problem in India.
8
A
national survey has reported high anemia prevalence rates of
1
Vaidya Chandra Prakash Cancer Research Foundation (SIRO), Dehradun, Uttarakhand, India.
2
Research & Development Department, Ipca Traditional Remedies Private Limited, Mumbai, Maharashtra, India.
3
Human Nutrition and Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 16, Number 2, 2010, pp. 205–211
ªMary Ann Liebert, Inc.
DOI: 10.1089=acm.2008.0573
205
79.2% in children below 3 years of age and 56.2% in women
aged 15–49 years.
9
An estimated 50%–95% of the anemia in
India is due to iron deficiency.
10
There are few data sources
on the anemia status of Indian school-going adolescents. It is
not known if adolescent school-going children have the same
high prevalence of anemia. Furthermore, they are a neglected
group in terms of micronutrient interventions, not reached
by the intervention strategies aimed at preschool children or
pregnant women.
8
A high prevalence of anemia has been reported among
adolescent Indian girls.
11
Anemia reported among adoles-
cent girls from public and government schools in Delhi was
50.8%.
12
Studies indicate that the prevalence of anemia
among those 5–14 years of age is in the range of 66.7%–
77%.
13,14
Vasanthi et al.
15
reported that anemia and iron
deficiency were higher in rural girls as compared to urban
slum adolescent girls. A study conducted on 1513 rural ad-
olescent girls in Gujarat indicated that 61% of the girls
were anemic.
16
A multicentric study carried out in 16 dis-
tricts of India indicated that the overall prevalence of anemia
ranged from 33% to 89% among pregnant women and more
than 60% among adolescent girls.
17
Under the anemia pre-
vention and control program of the Government of India,
iron and folic acid tablets are distributed to pregnant women,
but no such program exists for adolescent girls.
There is a high prevalence of anemia in school-going ad-
olescents in the Dehradun district. Hence, the present in-
vestigation was planned to take an initiative and study the
sustainable effect of the non-iron-containing Ayurvedic prep-
arations Sootshekhar Rasa
18
and Sitopaladi Churna
19
in im-
proving nutritional anemia in school-going adolescent boys
and girls.
Subjects and Methods
Study duration
This study was conducted from February to December
2005.
Design
This was a single-blind, randomized, controlled trial.
Ethical clearance and permission
The principal and teachers of the three schools involved
were given a detailed briefing on the study protocol. Prior
permission was taken from the management of all three
schools for conducting this study. This study was approved
by the State Government of Uttrakhand and a state-level com-
mittee comprising experts from the Department of Health,
Department of Ayurveda Yoga Unani Siddha & Homeopathy
(AYUSH), Ministry of Health & Family Welfare, Government
of India, and Department of Education & Administration was
formed to approve the study protocol and periodic monitoring
of the progress. Free and informed verbal consent of the stu-
dents and their parents was taken before the start of study.
Analytic procedures
Hemoglobin estimation was done by the cyanmeth-he-
moglobin method.
20
An internal Quality Assurance Program
was carried out within the laboratory periodically for con-
sistency. An external Quality Assurance Program was
carried out by exchanging of samples with laboratory of de-
partment of Human Nutrition and Gastroenterology, All
India Institute of Medical Sciences, New Delhi. Anemia was
diagnosed as per WHO recommendations.
5
Sampling
A total of 1646 school students comprising 1327 girls
and 319 boys (11–18 years) was initially screened for the
study from three schools in Dehradun district. The schools
were Government Girls Inter College, Rajpur Road, Gov-
ernment Inter College, Nathuvawala and Government In-
ter College, Maldevta. A total of 1121 (84.4%) of girls and
218 (68.33%) boys were found to be anemic (hemoglo-
bin <120 g=L).
Sample size
Sample size calculation showed that 222 students per
group were required to distinguish a difference in hemo-
globin concentration among 5 groups of 2.0 g=Lata5%
comparison-wise significance level and with a power of 90%,
assuming standard deviation of change hemoglobin con-
centration within each group of 5.35 g=L on the basis of
previous study.
21
Estimating a dropout rate of 10%, we
aimed to have at least 245 anemic students per group at
baseline.
Ayurvedic medicines
The composition of Ayurvedic medicines Sootshekhar Rasa
and Sitopaladi Churna is mentioned in Table 1.
Table 1. Composition of Sootshekhar Rasa
Traditional name English=scientific name Proportion
Suddha Parada Processed cinnabar 1 part
Suddha Gandhaka Processed sulphur 1 part
Dalchini Cinnamomum zeylanica 1 part
Choti Elachi Elleteria cardamomum 1 part
Tej patta Cinnamomum tamala 1 part
Nagkesar Mesua jerrea 1 part
Shankh Bhasma Turbinella pyrum 1 part
Swarna makshika
Bhasam
Chalco pyrite 1 part
Ropya Bhasma Argentum 1 part
Tamra Bhasma Cuprum 1 part
Dhatura’s seed Datura metel 1 part
Suhaga Borax sodium borate 1 part
Saunth Zingiber officinale 1 part
Kali mircha Piper nigrum 1 part
Choti pippal Piper longum 1 part
Bhringraj swarasa Eclipta alba Q.S. (for mardana)
Composition of Sitopaladi Churna
Traditional name English=scientific name Proportion
Mishri Sugar candy 16 part
Vanslochan Bambusa arumdimaceo 8 part
Choti Pippali Piper longum 4 part
Choti Elachi Ellettaria cardamomum 2 part
Dalchini Cinnamomum zeylanica 1 part
206 PRAKASH ET AL.
Quality control of medicines
The Ayurvedic medicines used for the present study were
prepared by the Bharat Bhaishajya Shala Private Limited,
Dehradun, using modern scientific methods (GMP) follow-
ing the stringent Ayurvedic procedures as mentioned in the
classic Ayurvedic text.
Bharat Bhaishajya Shala (BBS) is a private limited unit that
was incorporated in 1983. It now works in conjunction with
VCP Cancer Research Foundation, Dehradun. Over the
years, BBS has been involved in preparation of medicines to
meet in-house requirements of medication. These prepara-
tions are based on Ayurvedic traditional standards for raw
materials, processing, and finished products. Raw materials
thereby used meet the specifications given in various tradi-
tional texts. The processing of the drug is done in heat fur-
naces with programmed controls. A particle size analyzer is
employed to ensure proper grinding of the medicine and the
final end product is monitored by an x-ray powder diffrac-
tometer for adequate quality control.
Study design
A total of 1322 anemic students who consented for the
study were divided into 5 groups by simple randomiza-
tion. Few students with severe anemia (Hb <70.0 g=L)
were not included in the trial and were referred for proper
medical check-up. The students were blinded to their
treatment assignment. Students of group I were given
starch and this acted as a control group. Group II, III, and
IV students received Ayurvedic preparations Sootshekhar
Rasa and Sitopaladi Churna in various combinations, the
details of which are given in Table 2. Group V student
were given iron and folic acid tablet (IFA), which was the
positive control arm. On day 0, blood samples were drawn
from all subjects for Hb estimation and thereafter, Hb es-
timation was done on day 30, 60, 90, 170, 270 respectively.
Medicine was orally administered as per the schedule given
in Table 2.
Compliance
The enrolled students were followed at weekly intervals
for the treatment period. The field staffs visited all the school
regularly to supervise the consumption of the medicines to
ensure maximum compliance.
Statistical analysis
The data were analyzed by SPSS software (version 12.0,
SPSS, Chicago, IL). Mean and 95% confidence interval in
each group was calculated. Paired ttest was used to calculate
the sustainable effect within the group. One-way analysis of
variance was used for multiple comparisons among the
groups. A w
2
was carried out to compare anemia prevalence
between genders.
Results
The prevalence of severe, moderate, and mild anemia in
the present study was 1.2%, 53.5%, and 29.6%, respectively.
The overall prevalence of anemia was 81.3%. The prevalence
of anemia in girls (84.5%) was significantly higher than the
boys (68%). The prevalence of severe, moderate, and mild
anemia among girls were respectively 17 (1.2%), 710 (53.5%),
and 395 (29.6%). In boys, 167 (52.3%) and 50 (15.6%) were
mild and moderately anemic, respectively.
The hemoglobin concentration (mean SE) values of the
various intervention groups are given in Table 3. At baseline,
the mean hemoglobin was 97.4 13.2 g=dL and ranged from
96.4 0.8 to 98.3 0.8 in various groups. Significant increase
in Hb concentration after 30 days of treatment was observed
in group III. At the end of the treatment period, significant
increase in Hb concentration was noted in all treatment
groups. As compared to control, group III, i.e., daily dose of
Sootshekhar Rasa (SR) 250 mg þSitopaladi Churna (SC) 400 mg
and group V (receiving IFA) was found significantly better
than the other 2 treatment groups. During the follow-up
period (from 90 to 270 days), a significant increase in Hb was
noted in groups I and IV, respectively (Table 4). At day 270,
the mean gain of Hb level (g=L) in the four intervention
groups II, III, IV, and V was, respectively, 2.3 0.4, 6.9 0.6,
1.4 0.5, and 3.64 0.5. The maximum Hb gain was noted in
group III.
The study started with 1322 students; however, at the end
of the follow-up period there were 155 dropouts. The details
of students who opted out of the study are given in Table 5.
No adverse side-effect of the Ayurvedic medication was re-
corded in any of the participants.
Discussion
High prevalence of anemia (81.3%) among adolescent
school-going students observed in this study is consistent
with earlier findings of Bulliyy et al.
22
among non-school-
going adolescent girls from three districts of Orissa and the
study of Toteja et al.
17
on the prevalence of anemia among
adolescent girls in 11 states across India. DeMaeyer et al.
5
reported the prevalence of anemia in 6–12-year-old children
to be 36%, while study among 5–15-year-old urban school
children of Punjab was reported as 51.5%.
13
A literature
survey
23
indicates that anemia prevalence ranged from 19
to 88% across five different cities in India. Verma et al.
13
Table 2. Various Study Group and Treatment Schedule
Groups No. of students Status Intervention Dose Duration (days)
I 288 Control group Starch Daily 90
II 277 Treatment group SR 125 mg þSC 500 mg Daily 90
III 263 Treatment group SR 250 mg þSC 400 mg Daily 90
IV 251 Treatment group SR 250 mg þSC 400 mg Weekly 90
V 243 Positive control IFS
a
Daily 90
a
100 mg of elementary iron and 500 mg folic acid.
SR, Sootshekhar Rasa; SC, Sitopaladi Churna.
AYURVEDIC THERAPY FOR IMPROVING NUTRITIONAL ANEMIA 207
reported high (38%) anemia prevalence in adolescent stu-
dents belonging to higher socioeconomic groups. They also
found that nearly half (47.6%) of well-nourished children
were anemic. In semi-urban Nepal, the prevalence of anemia
in adolescent girls aged 11–18 years was found to be about
68.8%.
24
In Bangladesh, although the prevalence of anemia in
adolescence girls is very high, estimates vary widely: 43% in
rural girls and 20%–40% in urban girls.
25
Our study clearly indicates that the non-iron-containing
Ayurvedic preparations Sootshekhar Rasa and Sitopaladi
Churna (250 mg þ400 mg) taken daily for 90 days not only
improved the Hb concentration but sustained the same in the
next 180 days. These results are similar to those of the earlier
study carried out with daily dose of SR þSC on nonpregnant
women of a reproductive age group (11–45 years) in
Dehradun.
26
The 90-day-study on 119 nonpregnant anemic
women indicated a maximum gain of 16.0 g=L in Hb con-
centration. The maximum effect of SR þSC was seen in the
moderately anemic women. Similar trends are seen in the
present study. Out of the three combinations of Sootshekhar
Rasa and Sitopaladi Churna that were tried, group III (SR
250 mg þSC 400 mg, daily) was found to be significantly
better than the other two combinations. More importantly,
the gain in Hb was sustainable even after stoppage of
therapy.
Evidence indicates that preventive supplementation cou-
pled with nutritional education may be a more effective
strategy associated with better compliance and improve-
ment in iron status.
27
Before the start of this study, school
students were made aware regarding nutritional anemia.
After the initial screening, parents of all students who were
found to be anemic were informed. It may be possible that
many students may have received some extra care and di-
etary modification in their home because of the awareness
program. The significant increase in Hb concentration ob-
served in the controls and group IV after stoppage of
therapy may be attributed to this. The other factor could be
the seasonal effect. The study of Deepa et al.
28
revealed that
there was considerable seasonal variation in the iron status
of adolescent girls. The frequency of consumption of foods
rich in blood-forming nutrients by adolescents was higher
during the post–rainy season and winter as compared
to summer. Hence, higher mean Hb level was recorded
in adolescent girls in the winter season compared to sum-
mer. In our study, the 270-day Hb estimation was done in
winter.
Sootshekhar Rasa has been mentioned in various classical
Ayurvedic texts in the chapter of ‘‘Amla pitta Rogadhikara,’
26
which means to reduce acid in the body. Sootshekhar Rasa is
an important medicine of Rasa Shastra
29
(meaning science
of mercury). It is an herbo-mineral preparation and con-
tains many medicinal herbs, namely, Eclipta alba (Bhringraj),
Cinnamomum zeylanica,Zingiber officinale, etc., along with
Bhasma
30
of silver, copper, and mercury. Bhringraj is used
as a restorative and rejuvenative medicine in Ayurveda. It
is used as a tonic for keeping the body healthy and fit.
Similarly, Sitopaladi Churna is a traditional Ayurvedic
formulation for treatment of various upper and lower re-
spiratory tract ailments. The hypothesis of using these non-
iron Ayurvedic formulations was that it may improve the
absorption of iron in the gastrointestinal tract. Anemia will
result when the iron demands by the body are not met by
iron absorption, regardless of the reason. The gain in Hb
concentration observed in this study and in an earlier
study
26
conducted on nonpregnant women indicates that
Sootshekhar Rasa and Sitopladi Churna may play some role in
iron absorption.
Though the Ayurvedic formulation Sootshekhar Rasa con-
tained processed heavy metals in it; however, no adverse
side-effect was observed in any students. Sootshekhar Rasa
and Sitopaladi Churna are classic Ayurvedic preparations
routinely used by Vaidya in their routine clinical practice and
are considered to be safe and effective. Some Ayurvedic
preparations in their native form are toxic. To remove these
Table 3. Hemoglobin Concentration in g=L(Mean SE) of All Groups from Baseline to End of Study
Group Intervention No. Day 0 Day 30 Day 60 Day 90 Day 170 Day 270
I Starch 254 96.4 0.8 96.1 0.7 96.7 0.6 97.1 0.6 96.6 0.6 98.2 0.6
II SR 125 þSC 500 mg
once daily
245 97.6 0.8 98.1 0.7 98.7 0.7 99.6 0.6 98.0 0.6 99.9 0.6
III SR 250 þSC 400 mg
once daily
233 98.1 0.8 100.3 0.7
a
102.5 0.6
a
105.0 0.6
a
102.6 0.7
a
105.1 0.7
a
IV SR 250 þSC 400 mg
once weekly
220 96.7 0.9 96.6 0.8 97.2 0.6 97.1 0.6 95.9 0.7 98.1 0.7
V IFS daily 215 98.3 0.8 97.0 0.7 101.0 0.7
a
102.3 0.07
a
100.5 0.7
a
102.0 0.6
a
a
Differs significantly [P <0.01] as compared to control (group I).
SE, standard error; SR, Sootshekhar Rasa; SC, Sitopaladi Churna; IFS, 100 mg of elementary iron and 500 mg folic acid.
Table 4. Intragroup Comparison of Change
in Hemoglobin Levels g=L(Mean Change SE)
At end of
treatment
From end of
treatment to
end of follow-up
From start
to end of
follow-up
Groups 0–90-day 90–270 day 0–270 day
I 0.70 0.48 1.07 0.43* 1.78 0.43**
II 1.98 0.49** 0.26 0.39 2.24 0.45**
III 6.89 0.51** 0.08 0.53 6.97 0.61**
IV 0.34 0.54 1.06 0.04* 1.40 0.5**
V 3.92 0.60** 0.28 0.49 3.64 0.56**
*p<0.05 and **p<0.01.
SE, standard error.
208 PRAKASH ET AL.
toxic qualities of the metals, the preparations undergo vari-
ous processes of purification (Shodhana,Marana, and Sams-
kara).
31
The metal contents of the medicines are burned
several times at a high temperature. This repeated cycle of
burning and cooling for several times transforms the initial
contents into a nontoxic form. Metals and minerals are con-
sidered nonliving, and by treating them with herbs they are
converted to a living state, thereby becoming biocompatible.
The same metal processed with different herbs acts on dif-
ferent organs in the human body. Recently, Sathya et al.
32
studied the effect of various popular Ayurvedic Bhasmas
for chromosomal damage and single=double-strand DNA
breaks by micronucleus assay and the comet assay. Despite
the presence of traces of transformed toxic heavy metals in
Bhasmas, no induction of micronuclei or DNA damage
was observed. However, improper processing=manufacturing
of Ayurvedic medicines may result in dangerous conse-
quences.
33
In the diet, the quantity of bioavailable iron is important,
and this is determined by stimulation and inhibitory factors
that exist within a meal.
34
Among the iron absorption stim-
ulation factors in the diet are organic acids, in particular
ascorbic acid, which is found in citrus fruits. Among the iron
absorption inhibitory factors are phytic acid, which is found
in fibers, whole grains, and beans;
35
oxalic acid, which is
found in spinach and beetroot;
36
and tannin, which is found
in tea, coffee, and chocolate.
37
Calcium, which is present in
milk and dairy products,
38
and other minerals that are close
to iron in the periodic table, which compete with the same
intestinal absorption, also inhibit the absorption of iron.
6
United Nations Children’s Fund=WHO Joint Committee
on Health Policy
39
recommended iron supplementation for
all females between 10 and 49 years in countries where
over 30% of the population is anemic. Studies suggested
that iron and folic acid supplement given weekly twice
or even once is as effective as daily supplementation in
raising hemoglobin levels.
11,40,41
In the past, many daily
supplementation programs in developing countries have
been unsuccessful due to lack of supply and compliance.
42
Moreover, one of the problems of iron supplement is that
it causes unpleasant gastrointestinal side-effects such as
epigastric pain, nausea, vomiting, diarrhea, and so on. This
could be one of the reasons why many subjects discontinue
the intake of the supplement.
11
In the present study, no
unpleasant side-effects of the Ayurvedic formulations were
reported by any student. The compliance was good, though
there were some dropouts, but they were not related to
intervention.
World interest in adolescent health issues has grown
dramatically in the past decade. However, much of the at-
tention has been on adolescent pregnancy and sexually
transmitted diseases, including human immunodeficiency
virus infection, but adolescent nutrition has aroused little
interest.
43
Almost 25% of India’s population comprises girls
below 20 years of age. Adolescent pregnancies make up
10%–15% of the total and may be largely attributed to early
marriage.
44
Anemia has been related to reduced work ca-
pacity,
45
reduced ability to execute activities of daily living,
46
and poor pregnancy outcome.
47
Study shows that children
with iron deficiency present worse performance in psycho-
motor test than do nonanemic children.
48
Conclusions
The highest prevalence of anemia exists in the developing
world where its causes are multifactorial. With limited re-
sources and complex socioeconomics in the developing
world, combating anemia is a global public health chal-
lenge.
7
Our study indicates that there is a high prevalence of
anemia in school-going adolescent boys and girls. Adoles-
cent health is the most important indicator of development of
a nation. Hence, urgent attention is needed in this area.
Evidence suggests that preventive supplementation coupled
with nutrition education may be a more effective strategy
associated with better compliance and improvement in iron
status.
27
The result from our study indicates that the noniron
Ayurvedic preparations Sootshekhar Rasa and Sitopaladi
Churana can be used to improve the nutritional anemia status
in adolescents without any side-effects. However, larger
multicentric studies are required to assess the exact potential
of the observed results.
Acknowledgments
The authors are grateful to the then Chief Secretaries Dr.
R. S. Tolia and Mr. S. K. Das, Government of Uttarakhand,
for taking the initiative and granting permission to carry out
this project. We also thank Ipca Laboratories Ltd., Mumbai
Table 5. Dropouts Details of Participants
Group Category No.
Lost to
follow-up
Objection
by parents
Other illness
& treatment
Lack of
compliance Total
I Boys 03 04 10 11 09 34
Girls 31
II Boys 05 05 10 10 10 35
Girls 30
III Boys 04 03 08 07 12 30
Girls 26
IV Boys 08 05 07 07 06 25
Girls 17
V Boys 06 04 08 09 10 31
Girls 25
AYURVEDIC THERAPY FOR IMPROVING NUTRITIONAL ANEMIA 209
and Department of AYUSH, Ministry of Health & Family
Welfare, Government of Uttarakhand for providing financial
support. We thank Dr. G. S. Toteja Scientist F, Indian Council
for Medical Research, New Delhi, for guidance, study de-
sign, and arranging collaboration between Vaidya Chandra
Prakash Cancer Research Foundation (Scientific & Industrial
Research Organization) and All India Institute of Medical
Research, New Delhi, for ensuring quality control. Thanks
also to Department of Health & Education, Government of
Uttarakhand for mobilizing state machinery for logistic
support and ethical & technical issues. We are grateful to
principals of all the schools for giving consent for this study,
and all field workers and staff of VCPCRF and Ipca La-
boratories who helped in the drafting of the manuscript.
Disclosure Statement
No competing financial interests exist.
The Sootshekhar Rasa and Sitopaladi Churana combination
has recently been granted a license from the authority of
federal government of Uttarakhand, India and the drug is
now commercially known as NUMAX.
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Address correspondence to:
Vaidya Balendu Prakash, B.Sc., B.A.M.S.
Research & Development Department
Ipca Traditional Remedies Private Limited
142-AB Kandivali Industrial Estate
Kandivali West
Mumbai, Maharashtra 400 067
India
E-mail: balenduprakash@gmail.com
AYURVEDIC THERAPY FOR IMPROVING NUTRITIONAL ANEMIA 211
... In six publications, it was not possible to extract the sample size because it was not reported. Adolescents were anaemic at baseline in four publications (33)(34)(35)(36) . ...
... In Sri Lanka, iron and zinc capsules consumed daily on school days for 24 weeks showed improvements in the prevalence of anaemia and zinc deficiency but did not decrease the rate of stunting among adolescents (38) . Various publications compared the efficacy of different micronutrient supplementation combinations among anaemic adolescents (33)(34)(35) and vitamin D deficient adolescents (39) . A sample of 178 anaemic adolescent schoolgirls in Bangladesh received iron-folic acid -30 mg Fe and 400 μg folic acidtablets or multiple micronutrients (MMN) tablets (15 micronutrients, including iron and folic Adolescent undernutrition in South Asia 5 acid) (35) . ...
... Both supplementation frequencies were equally efficacious in decreasing anaemia; however, twice-weekly MMN was more efficacious than once-weekly MMN in improving vitamin A, riboflavin and folic acid status. Another randomised controlled trial studied the effect of non-iron containing ayurvedic preparations to treat nutritional anaemia in adolescent students in India (33) . The authors found that a daily dose of two non-iron containing ayurvedic preparations improved anaemia in the study participants. ...
Article
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Undernutrition is a growing public health challenge affecting growth and development during adolescence in many low- and middle-income countries. This scoping review maps the evidence on adolescent undernutrition (stunting, thinness and micronutrient deficiencies) in South Asia and highlights gaps in knowledge. Using Arksey and O’Malley’s framework and the Joanna Briggs Institute Reviewers’ Manual, the search included electronic bibliographic databases (Medline (OVID), Embase, Cochrane Library, Web of Science, CINAHL, PsycInfo, and Scopus) as well as various grey literature sources published up to March 2019. In total, 131 publications met the inclusion criteria of this review. All the included evidence used quantitative data and 115 publications used a cross-sectional design. Nearly 70% (n=86) of the included publications were conducted in India. Prevalence of undernutrition was reported based on different growth references and cut-offs. Evidence is divided into publications that included an intervention component (n=12) and publications that did not include an intervention component (n=116), and presented in a narrative synthesis. This scoping review provides a wide range of publications on adolescent undernutrition in South Asia and identifies future research priorities in the field.
... Community or facility-based trials published during years 2005-2018 were reviewed. [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] Type of studies Seven were RCTs [18,19,[23][24][25]29,31] and the remaining 8 were quasi-experimental trials (before and after intervention). [16,17,20,22,[26][27][28]30] Of the 15 studies, 12 were from outpatient or inpatient departments of hospitals, two from schools or colleges and study site was not clearly mentioned in one study. ...
... Community or facility-based trials published during years 2005-2018 were reviewed. [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] Type of studies Seven were RCTs [18,19,[23][24][25]29,31] and the remaining 8 were quasi-experimental trials (before and after intervention). [16,17,20,22,[26][27][28]30] Of the 15 studies, 12 were from outpatient or inpatient departments of hospitals, two from schools or colleges and study site was not clearly mentioned in one study. ...
... Sample size in the selected trials varied from 25 to 1646. Of the total studies reviewed, six were among adults, [17,19,20,28,29,31] three among adolescents, [23][24][25] four among pregnant women, [16,26,27,30] one each among children aged 1-16 years, [18] and geriatric (50-80 years) patients. [22] Intervention Both iron containing and non-iron containing Ayurvedic preparations were studied to assess their effect on anemia [ Table 1]. ...
Article
Full-text available
Anemia is an important public health problem in India. Complementary and alternative systems/traditional medicines can also be explored for the control of anemia apart from the existing platforms. Interventions with various herbal and iron formulations have been reported in Ayurveda. Hence, this review was aimed to explore the effect of various ayurvedic drugs on anemia from the existing literature. Literature was searched in PubMed, Google Scholar, Cochrane Library, Medline (Ovid), IndMed and by cross-referencing the articles. Key words used included “Pandu Roga,” “Anemia” and “Ayurveda.” The search was restricted to original research articles published in the English language from January 2005 to June 2018 among human subjects. Randomized and nonrandomized control trials were included in this review, which assessed the effectiveness of ayurvedic drugs on improvement in hemoglobin as well as subjective parameters such as weakness, anorexia, and pallor. Effectiveness of 17 different Ayurvedic preparations was assessed in the studies. The maximum increase in hemoglobin was observed by the drug Sarva-juara-hara-lauha in a dose of 500 mg (145.55 mg elemental iron), when administered daily for 30 days using honey as a vehicle. Increase in hemoglobin from 7.3 ± 1.9 to 12.1 ± 1.6 g/dL was observed. All studies that assessed the effect of the drugs on the basis of subjective parameters reported a decreased percentage of complaints by the patients. No adverse reactions were reported. In conclusion, administration of ayurvedic drugs is an effective and safe approach for prevention and management of anemia in various population groups. However, larger multicentric studies are required to assess the exact potential of these drugs in the control of anemia.
... Los terapéuticos empleados para tratar la anemia incluyeron formulaciones tradicionales japonesa, china y ayurvédica; la Espirulina (alga filamentosa); una dieta rica en hígado y músculo, y el extracto de lechuga. El número de sujetos incluidos en el estudio varió de 1 a 1646 participantes, con respecto al sexo, dos estudios se realizaron sobre población femenina (Akase et al. (19) y Baumslag et al. (20) ), tres en participantes de ambos sexos (Prakash et al. (21) , Selmi et al. (18) y Afolabi et al. (17) ), mientras que el estudio experimental y el de serie de casos no indicaron el sexo de los participantes. ...
... Solo en el caso del estudio Afolabi et al. (17) , el diseño y estrategia del estudio fue diferente al resto de los estudios, pues la unidad de análisis fue la célula sanguínea falciforme humana. Los ECA y el estudio experimental consideraron como controles del estudio fármacos como la ferromia (Akase et al. (17) y el almidón (Prakash et al. (21) ). Los estudios cuasiexperimentales, el reporte y la serie de casos, emplearon como controles el perfil de diagnóstico y características de línea base sobre el mismo grupo de estudio. ...
... El estudio de Akase et al. (17) no precisa si se trata, o no, de un doble ciego; por otro lado, no se describe el método de aleatorización de los participantes, en tanto que el trabajo de Prakash et al. (21) Afolabi et al. (17) , encuentra que los niveles de células sanguíneas falciformes tratadas con los extractos metanólicos de las plantas y del aceite de la semilla se redujeron significativamente (p < 0,05). La inhibición de la polimerización de las células en las mujeres se logró con todos los extractos de las plantas; sin embargo, solo el extracto metanólico de Solenostemon monostachyus e Ipomoea involucrata fueron efectivas en las células masculina, es decir, que la efectividad de los extractos de estas plantas es dependiente del sexo. ...
Article
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Objetivo: Identificar, evaluar y sistematizar información acerca de la eficacia de la trofoterapia en el manejo de la anemia. Materiales y Métodos: Se realizó una búsqueda entre mayo y junio del 2014 en las bases de datos: PUBMED, EBSCO, Science Direct, Scopus, EMBASE. Para la selección de los artículos se consultó la Cochrane Handbook of Systematic Reviews of Intervention, versión 5.1.0. Se utilizó el formulario de extracción de datos Cochrane (2007) modificado para obtener la información de los artículos según los criterios de inclusión. Para evaluar la calidad metodológica de la evidencia se empleó la “Escala de Jadad”, en el caso de los ensayos clínicos aleatorizados; y una lista de calidad estándar para estudios primarios de diferentes campos, descritos. Resultados: Seis (06) artículos cumplieron con los criterios de inclusión; solo dos (02) de ellos tuvieron una adecuada calidad metodológica. Dos (02) estudios referían el uso de preparados tradicionales en el tratamiento de la anemia; dos (02) estudios consideraron alimentos para el tratamiento de la anemia y un (01) estudio analizó extractos metanólicos. El término de “trofoterapia” o “trophoterapy”; no fueron encontrados en los tesauros (DeCS y MeSH) y ningún artículo científico hizo referencia al término ““trophoterapy” en el título. Conclusiones: Es importante definir y armonizar los conceptos en Trofoterapia, para que éstas puedan ser estudiadas, validadas e incorpradas en el sistema convencional de salud; sin embargo, existen indicios de la eficacia de Solenostemon monostachyus, Ipomoea involucrata, el aceite de semilla de Carica papaya y del alga espirulina para el tratamiento de la anemia falciforme y nutricional; pero estas investigaciones no se han abordado en el marco de la filosofía y paradigmas de la trofoterapia.
... Vanga Bhasma It is good for fatty defects, used in urinary diseases and offers beneficial effects in anemia. 10 Shukti Bhasma Having diuretic action, treat blurred vision and used externally for blisters. 11 ...
Article
Full-text available
Metals and metallic preparations have a great historical background in Ayurveda system. Metals such as; Parada (Mercury), Rajata (Silver), Tamra (Copper), Swarna (Gold), Lauha (Iron), Vanga (Tin) and Yasada (Zinc) possessing some therapeutic value. However these metals can’t be used without processing or purification, therefore they are used in incinerated form as Bhasma. These herbo-metallic preparations offer different therapeutic values and utilizing since evaluation of ayurveda. The proper preparation method, dose regimen and duration of use are some important aspects need to be considered while using Bhasma. Bhasma may produce severe adverse effects if used without considering precautionary measurements. Present article described various ayurveda perspective of Bhasma. Keywords: Ayurveda, Bhasma, Herbo-metallic, Incinerated.
... Sitopaladi churna can give other medicinal beneficial effects when it is used in combination. Sitopaladi churna (400 mg) in combination with Sootshekhar Rasa (250 mg) can be used for the treatment of nutritional anemia in teenagers while Sitopaladi churna in combination with Kumar kalyan ras, can be used to manage the growth and development process of a child (5). ...
Article
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"Sitopaladi churna," a well-known formulation of Ayurveda, is prescribed to treat the disease like Bronchitis, Pneumonia, allergic conditions, viral infection of the respiratory tract and as a natural antioxidant. A novel method based on reversed-phase high-performance liquid chromatography (RP-HPLC) coupled to photodiode array detector was established and validated for sitopaladi churna. Here, HPLC fingerprints data obtained for 28 samples including standard sample were then treated to chemometric analysis like principal component analysis and hierarchical clustering analysis for further analysis to evaluate the differences in market samples of sitopaladi churna. Additionally, one major marker compound, piperine was quantified and it also facilitated for relative retention time. The simulative mean spectrum was also generated. The validation results showed that the developed method was simple, precise and stable. Thus, the developed chromatographic method adjoined with multivariate analysis can be used as an efficient and practical approach for quality assessment of sitopaladi churna.
... In 70.5% cases marked reductions were noticed in their study [35] . Point is also to be noticed in the study that the formula of the Rasa is adopted [36] . ...
Article
Full-text available
Sootashekhara Rasa is an important formulation in the practice of Ayurveda, Which is used in Amla Pitta(Hyperacidity), Agnimandya(Digestive impairment), Atisara(Diarrhoea), Gulma(Abdominal Lump), Kasa(Cough), Grahani(Malabsorption syndrome) and Rajayakshma(Tuberculosis). Four different formulations with the same name and one Laghu Sootashekhara Rasa are found in the literature. Among these all, the Sootashekhara Rasa, described in Yoga Ratnakara is famous and came into clinical & trade practice. This is also modified by different scholars with the time. Main formula have 19 ingredients including mineral, animal and plant origin drugs. Since it is having Gold as one of the ingredients that make it costly too. Today, in the market it is available with and without gold by the name of Swarna Sootashekhara Rasa and Sada Sootashekhara Rasa or Sootashekhara Rasa (Swarna Rahita). An Attempt has been made to critically review the formula. The changes was made by scholars to make it safer, cheaper with maintaining its efficacy. By reviewing the properties of ingredients it can be said that it may effective in all the indications mentioned.
... [21] Some practitioner are also modifying the formula and practicing in their clinical practice, although no clear justification is reported. [22] . ...
Article
Full-text available
Sootashekhara Rasa is an important formulation in the practice of Ayurveda, Which is used in Amla Pitta(Hyperacidity), Agnimandya(Digestive impairment), Atisara(Diarrhoea), Gulma(Abdominal Lump), Kasa(Cough), Grahani(Malabsorption syndrome) and Rajayakshma(Tuberculosis). Four different formulations with the same name and one Laghu Sootashekhara Rasa are found in the literature. Among these all, the Sootashekhara Rasa, described in Yoga Ratnakara is famous and came into clinical & trade practice. This is also modified by different scholars with the time. Main formula have 19 ingredients including mineral, animal and plant origin drugs. Since it is having Gold as one of the ingredients that make it costly too. Today, in the market it is available with and without gold by the name of Swarna Sootashekhara Rasa and Sada Sootashekhara Rasa or Sootashekhara Rasa (Swarna Rahita). An Attempt has been made to critically review the formula. The changes was made by scholars to make it safer, cheaper with maintaining its efficacy. By reviewing the properties of ingredients it can be said that it may effective in all the indications mentioned.
Article
Full-text available
Ayurveda the ancient science well known for its potential therapeutic effects with unique metallic, herbal juices/fruits in the treatment of chronic ailments. A well- known ayurvedic potent preparation, Bhasma is also known as ash which is a metallic base prepared by sophisticated pharmaceutical processes also plays a major role in acute, sub-acute, and chronic diseases. In order to determine its quality and purity to make sure the acceptability, the safety of the formulation standardization is very necessary. In this short review, an attempt has been made to present ancient methods to standardize physical characterstics like Verna, Nisvadutam, Nishchandratvam, Varitara, Unama, Rekhapurmatvam, Slakshmatvam..etc.,and chemical characterstics of bhasmas like Apurnabhavta, Niruttha, Amla Pariksha with advanced methods like SEM, TEM, and NPST, along with other natural and ancient analytical techniques. Keywords: Bhasmas, Standardization, Analytical methods, SEM, TEM.
Article
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Based on experience of author in his practice a pilot study was carried out on 600 non-pregnant anemic women of reproductive age group (11-45 years) from Dehradun district to generate baseline data on the efficacy of Ayurvedic iron preparation (Ayas)**, Ayurvedic non iron preparation (SS)*** and combination of these two. For comparison a group of subjects was also given IFA tablet. In a 90 days duration study, the maximum gain (1.8 g%) in hemoglobin level was recorded with SS + Ayas, followed by 1.6 g % with Ayas; 1.5 g % with SS and 1.1 g % with IFA. The good gain (1.5 g %) in haemoglobin level of anemic women given non-iron Ayurvedic preparation 'SS' was very encouraging as it is cost effective and showed almost no side-effects in the present study. Sootshekhar Rasa has been mentioned in various classical Ayurvedic text in the chapter of 'Amla pitta Rogadhikara', which means to reduce acid in the body. Similarly, Sitopaladi is a well-known classical Ayurvedic formulation, which has been described in the text as cough reducing agent. In the present study, author used these medicines for the formulation first time in improving nutritional anemia in non-pregnant women. The hypothesis for using non-iron Ayurvedic preparation SS was that it improves the absorption of iron in gastrointestinal tract. The results of this pilot study to indicate the possibility of using SS for improving nutritional anemia. Further studies are required covering larger population from different parts of the country to ascertain efficacy, sustainability of hemoglobin level after discontinuation of treatment and also to understand the intrigue phenomenon about the character and pharmacology of these Ayurvedic formulations.
Article
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Background: Iron deficiency and its consequent anemia constitute the commonest micronutrient deficiency in the world. Objective: We investigated whether long-term, weekly iron-folate supplements administered at school would improve hemoglobin and ferritin concentrations in adolescent girls, including those with mild-to-moderate anemia and hemoglobin concentrations indicating borderline anemia. Design: Subjects were 266 girls with hemoglobin concentrations of 80-119.9 g/L (group A) and 358 girls with hemoglobin concentrations of 120-130 g/L (group B) who were otherwise healthy. Two hundred sixty-six girls in group A and 268 girls in group B were randomly assigned to receive either 60 or 120 mg Fe plus 3.5 mg folic acid weekly for 22 wk. Ninety of the girls in group B were randomly assigned to receive only 5 mg folic acid weekly. Capillary hemoglobin and plasma ferritin were measured at baseline and after 12 and 22 wk of supplementation. Results: By the end of the study, 2% of the girls had dropped out and > 96% had taken > or = 20 of the 22 tablets; side effects were minimal. Mean plasma ferritin increased significantly in all iron-supplemented groups, independently of initial hemoglobin values and iron doses. Ferritin concentrations decreased in the girls supplemented with folic acid only. As expected, hemoglobin responses to iron were higher in group A than in group B and increases were positively correlated with initial plasma ferritin. Hemoglobin failed to respond to folate supplementation if initial plasma ferritin concentrations were low. Mean hemoglobin increased significantly and consistently in relation to the length of treatment. Conclusion: Long-term, weekly iron-folate supplementation was found to be a practical, safe, effective, and inexpensive method for improving iron nutrition in adolescent schoolgirls.
Article
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Traditional medicine use is common in developing countries and increasingly popular in the western world. Despite the popularity of traditional medicines, scientific research on safety and efficacy is limited. However documented fatalities and severe illness due to lead poisoning are increasingly recognized to be associated with traditional medicine use. As society becomes more globalized, it is imperative for pharmacists and health care providers to learn about the safety of traditional medical practices. The information presented educates and alerts pharmacists and health care providers about the potential of traditional medicines to cause lead encephalopathy. Case reports were located through systematic literature searches using MEDLINE, CINAHL, AMED, CISCOM, EMBASE and The Cochrane library from 1966 to the February 2007. Reference lists of identified articles and the authors' own files were also searched. Inclusion criteria were cases of human lead encephalopathy associated with traditional medical practices. There were no restrictions regarding the language of publication. Data were subsequently extracted and summarized in narrative and tabular form. We found 76 cases of lead encephalopathy potentially associated with traditional medicine. Ayurvedic medicines were associated with 5 cases (7%), Middle eastern traditional medicines with 66 cases (87%) and 5 cases (7%) with other traditional medicines. Of the 76 cases, 5% were in adults and 95% were in infants and young children. Of the 4 adult cases, at least one was left with residual neurological impairment. In infants and young children, among 72 cases 8 (11%) were fatal, and at least 15 (21%) had residual neurological deficits. Traditional medicine users should be screened for lead exposure and strongly encouraged to discontinue metal-containing remedies. Therefore, the United States Food and Drug Administration and corresponding agencies in other countries should require and enforce heavy metal testing for all imported traditional medicines and "dietary supplements".
Article
The investigation focussing on “Seasonal variations in iron status of adolescent girls in Dharwad Taluk” was carried between June 2001 to May 2002. The iron status of the adolescent girls was assessed by dietary, clinical and biochemical method. The frequency of consumption of foods rich in blood forming nutrients by the subjects was higher during rainy and winter compared to summer. Irrespective of locality, subjects recorded higher mean haemoglobin level during winter (9.88 g/dl) and rainy (9.87 g/dl) season compared to summer (9.63 g/dl). However, seasonal variations were not reported in any of the anaemia symptoms.
Article
Four hundred and fifty four adolescent girls (11-18 years) were screened for nutritional disorders by anthropometry (weight, height and triceps skinfold measurements), clinical examination and hemoglobin estimation. Of these, 56% belonged to high socio-economic groups (Group A) and the rest (44%) to lower middle class (Group B). A large number of girls from Group B were undernourished (35.5% had weight/height2 less than the fifth percentile of reference standard) stressing the need for nutritional screening, nutrition and health education. Obesity was prevalent in 3.1% of Group A adolescents. Goitre grade I or more was observed in a high proportion of Group B girls, stressing the need for continued consumption of iodized salt in Delhi. Anemia appears to be a major health problem in adolescent girls in both groups (47, 56% in Groups A and B, respectively) underlying the ned for iron supplementation along with health education.
Article
Crude aconite is an extremely lethal substance. However, the science of Ayurveda looks upon aconite as a therapeutic entity. Crude aconite is always processed i.e. it undergoes 'samskaras' before being utilised in the Ayurvedic formulations. This study was undertaken in mice, to ascertain whether 'processed' aconite is less toxic as compared to the crude or unprocessed one. It was seen that crude aconite was significantly toxic to mice (100% mortality at a dose of 2.6 mg/mouse) whereas the fully processed aconite was absolutely non-toxic (no mortality at a dose even 8 times as high as that of crude aconite). Further, all the steps in the processing were essential for complete detoxification.
Article
We investigated the effect of calcium on iron absorption in 126 human subjects. Addition of calcium chloride to wheat rolls significantly reduced iron absorption. Doses between 40 and 600 mg Ca were studied. The inhibition was clearly dose related up to 300 mg Ca. Calcium added to the dough when making the rolls reduced phytate degradation during fermentation and baking. As little as 40 mg Ca added to 80 g flour reduced phytate degradation by 50%, thus increasing the phytate content of the rolls to levels interfering with iron absorption. Calcium also had a direct dose-related inhibiting effect on iron absorption, noted by adding calcium to the rolls after they had been baked instead of to the dough. Iron absorption was reduced by 50-60% at doses of 300-600 mg Ca. Giving 165 mg Ca as milk, cheese, or calcium chloride reduced absorption by 50-60%. The same amount of calcium also significantly reduced heme-iron absorption, suggesting that the effect of calcium is related to the mucosal transfer of iron. The observed marked inhibitory effect on iron absorption of calcium in amounts frequently encountered in normal meals has important nutritional implications.