Integration of Ayurvedic formulations with iron folic acid in the treatment of nutritional anaemia among school going adolescents of Dehradun District

Abstract

Combating anaemia is a global public health challenge of the developing world. Nutritional anaemia is a serious health problem faced by Indian school children. An investigation was taken up to study the effect of non iron containing Ayurvedic preparation Sootshekhar Rasa (SR) plus Sitopaladi Churna (SC) along with iron and folic acid (IFA) for improving nutritional anaemia among adolescent school going students of Dehradun district in Northern India. The blinded, controlled randomized trial comprised of 820 adolescents anaemic students aged 11 - 18 years. The anaemic students were randomly divided into 4 groups, students of group I (control) received starch, group II, III, and IV students received daily dose of (SR 250 mg + SC 400 mg), IFA and (SR 250 mg + SC 400 mg) + IFA, respectively. All the students received treatment for 90days and were followed up for next 180days. At the end of follow-up (day 270), significant increase of haemoglobin (Hb) level from the base line was recorded in all treatment groups. The maximum gain in Hb concentration was noted in group IV (10.1 ? 0.6 g/L), which was significantly higher than any other group. There were 123 drop-outs; however, no major side effect of treatment was noted in any student. We conclude that daily dose of (SR 250 mg + SC 400 mg) along with IFA can produce sustainable improvement of nutritional anaemia in adolescent students.

Full text

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2016 / Volume 6 / Issue 1 / e5
Original article
Integration of Ayurvedic formulations with iron folic acid in the treatment of
nutritional anaemia among school going adolescents of Dehradun District
Vaidya Balendu Prakash1,*, Shyam Prakash2, Rajesh Sharma3, Megha Prakash3, Shikha Prakash3, Kiran Parmar3
1Ipca Laboratories Limited, 142-Ab Kandivili Industrial Estate, Kandivili (West), Mumbai, India; 2Department of Human Nutrition
and Gastroenterology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India; 3VCP Cancer Research Foundation,
Turner Road, Clement Town, Dehradun, India
ABSTRACT
Combating anaemia is a global public health challenge of the developing world. Nutritional anaemia is a
serious health problem faced by Indian school children. An investigation was taken up to study the effect
of non iron containing Ayurvedic preparation Sootshekhar Rasa (SR) plus Sitopaladi Churna (SC) along
with iron and folic acid (IFA) for improving nutritional anaemia among adolescent school going students
of Dehradun district in Northern India. The blinded, controlled randomized trial comprised of 820
adolescents anaemic students aged 11 - 18 years. The anaemic students were randomly divided into 4
groups, students of group I (control) received starch, group II, III, and IV students received daily dose of
(SR 250 mg + SC 400 mg), IFA and (SR 250 mg + SC 400 mg) + IFA, respectively. All the students
received treatment for 90days and were followed up for next 180days. At the end of follow-up (day 270),
significant increase of haemoglobin (Hb) level from the base line was recorded in all treatment groups.
The maximum gain in Hb concentration was noted in group IV (10.1 ± 0.6 g/L), which was significantly
higher than any other group. There were 123 drop-outs; however, no major side effect of treatment was
noted in any student. We conclude that daily dose of (SR 250 mg + SC 400 mg) along with IFA can
produce sustainable improvement of nutritional anaemia in adolescent students.
Keywords In folic acid, nutritional anaemia, Sootshekhar Rasa, Sitopaladi Churna
INTRODUCTION
Conditions like anaemia, vitamin A and iodine deficiency
continue to pose a major health challenge for growing children
and adolescents especially in developing countries like India,
even after scientific advances in treatment strategies. In spite of
its technical feasibility, the transient methodology of providing
supplements with food has not been effective in developing
world due to issues with delivery and compliance (Ahluwalia,
2002).
A range of distinctive factors from nutritional deficiencies
of iron, Vitamin A, B12 and folate to malaria and chronic
inflammatory disorders can cause anaemia (Clark, 2008).
However, the most severe consequence of iron depletion is Iron
Deficiency Anaemia (IDA).
IDA is a commonly occurring nutritional deficiency
worldwide generally arising when body’s iron demands are not
met due to inadequate intake, impaired absorption or transport,
physiologic losses associated with reproductive age, or post
disease chronic blood loss (De Maeyer et al., 1989).
Iron deficiency is very common amongst infants and young
children that have profound adverse effects on their
development patterns (Vijayaraghavan et al., 1990). Nutritional
intake during childhood has a huge impact on a child’s present
and future health (Kanani et al., 1997). High iron requirement
of the body, if not met, makes early childhood one of the
highest risk period for iron deficiency (Domellof et al., 2014).
Along with causing symptoms such as tachycardia, dizziness,
shortness of breath and fatigue, anaemia also leads to cognitive
delays and poor achievement scores (Kotecha et al., 2002).
Iron deficiency is a global health issue and prevention or
treatment, particularly in children in developing countries, is a
major health challenge. Nutritional anaemia adversely affects
the mental and physical health of children and also, causes an
increase in morbidity. Furthermore, providing iron supplements
in later ages may not be effective in combating the effects
(Kapil, 2003). A national nutritional anaemia control program
was launched to test the effects of iron supplementation in
pregnant women, in India, when given after first trimester of
pregnancy. The supplementation, however, failed to bring any
significant increase in their body’s iron content, suggesting that
it is important to maintain iron store of a women before she is
pregnant (Deshmukh et al., 2008). Despite all efforts made in
this regard, nutritional anaemia continues to be a severely
major health issue, suggesting that the efforts have been
ineffective.
High prevalence of anaemia has been reported among
Indian adolescent girls (Shobha and Sharada, 2003). However,
adolescent school children are a neglected group in terms of
micronutrients interventions strategies aimed at preschool
children or pregnant women (Pollitt et al., 1985). There is not
much change as in 2010, the overall prevalence of anaemia was
noted to be 32.9% with an increase in incidences in children
*Correspondence: Vaidya Balendu Prakash
E-mail: balenduprakash@gmail.com
Received September 3, 2015; Accepted February 19, 2016; Published
Feburary 29, 2016
doi: http://dx.doi.org/10.5667/tang.2015.0026
© 2016 by Association of Humanitas Medicine
This is an open access article under the CC BY-NC license.
(http://creativecommons.org/licenses/by-nc/3.0/)

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Table 1. Various study group and treatment schedule
Groups
No. of Students
Status
Intervention
Dose
Duration (Days)
I.
185
Control Group
Starch
Daily
90
II.
178
Treatment Group
SR + SC*
Daily
90
III.
166
Treatment Group
IFA#
Daily
90
IV.
168
Treatment Group
SR + SC + IFA
Daily
90
*Sootshekhar Rasa 250 mg and Sitopaladi Churna 400 mg, #100 mg of element iron and 500 µg of folic acid.
below the age of 5 years, over a period of 10 years (Kassebaum
et al., 2014).
An earlier study with non iron containing Ayurvedic
preparations Sootshekhar Rasa plus Sitopaladi Churna has
shown encouraging results in sustaining and improving
nutritional anaemia in school going adolescent boys and girls
(Acharya, 1935; Prakash et al., 2010). The present investigation
was thus initiated to study if combining SR+SC along with iron
and folic acid (IFA) produced a better results than SS and IFA
given separately in improving nutritional anaemia in school
going adolescents.
MATERIALS AND METHODS
Duration of Study
This study was conducted from February to November 2006.
Design
Single blinded, randomized controlled clinical trial: Ethical
clearance and permission: the principal and teachers of all the
schools involved were given a detailed briefing on the study
protocol. Prior permission was taken from the management of
all the three schools for conducting this study. This study was
approved by State Government of Uttarakhand and a state level
committee comprising of experts from Department of Health,
Department of AYUSH, Ministry of Health and Department of
Education and Administration was formed to approve the study
protocol and periodic monitoring of the progress. Free and
informed verbal consent of the students and their parents was
taken before the start of study.
Analytic Procedures
Haemoglobin estimation was done by cyan meth-haemoglobin
method. Internal quality assurance program was carried out
periodically for consistency. External quality assurance
program was carried out by exchanging samples with
laboratory of Department of Human Nutrition and
Gastroenterology, All India Institute of Medical Sciences, New
Delhi. Anaemia was diagnosed as per WHO recommendation.
Sampling
A total of 1014 school students comprising of 598 girls and 416
boys (11 - 18 years) were initially screened for the study from 8
different schools:
i) Governments Girls Inter College, Raipur
ii) Government Inter Collage, Maldevta
iii) Shiv Junior High School, Maldevta
iv) Government Junior High School, Miyawala
v) Doon Higher Secondary School, Shyampur
vi) Government Girls High school, Raipur and Bahadur
Sigh Negi Girls Inter Colle, Gujrada
vii) Government Junior High School, Gujrara
viii) Government Junior High School, Chaktunwala.
Total number of anaemic students (n = 820) were then divided
randomly into four groups with a specific treatment each. The
students were blinded to the treatment assignment.
Ayurvedic Medicines
The Ayurvedic medicines Sootshekhar Rasa and Sitopaladi
Churna were manufactured and provided by Bharat Bhaishajya
Shala Pvt Ltd., Dehradun, using modern scientific methods,
GMP. These preparations are based on Ayurvedic traditional
standards for raw materials, processing and finished products.
Raw materials thereby used meet the specifications laid in
various traditional texts. The processing of the drug is done in
heat furnaces with programmed controls. A particle size
analyzer is employed to ensure proper grinding of the medicine
and the final end product is monitored by X-Ray Powder
Diffractometer for adequate quality control.
Study Design
The study comprised of 820 students. Participating students of
group I were given starch and acted as control group. Group II
participants received Ayurvedic preparations (SR 250 mg + SC
400 mg), group III received 100 mg elementary iron and 500µg
IFA, group IV students received (SR 250 mg + SC 400 mg)
along with IFA. On the first day (day 0), blood samples were
drawn from all subjects for haemoglobin (Hb) estimation.
Thereafter, Hb estimation was done on day 30, 60, 90, 170, and
270 respectively. All the drugs were orally administered as per
the schedule given in Table 1.
Compliance
The enrolled students were followed at weekly interval for the
treatment period. The field staff visited all the schools regularly
to supervise the consumption of the medicines to ensure
maximum compliance.
Statistical analysis
The data was analysed by SPSS software (version 12.0, SPSS,
Chicago, IL, USA). Mean and 95 percent confidence interval in
each group were calculated. A paired test was used to calculate
the change in Hb levels within the group. One way ANOVA
was used for multiple comparisons among the groups.
Results
Around 80.8% of the total students studied (i.e. 820 out of 1014
students) were found to be anaemic. A total of 78.6% (327)
were boys while 82.4% (493) were girls. The haemoglobin
concentration of the various intervention groups at different
time periods are given in Table 2. At baseline, the mean
haemoglobin concentration of various groups was 94.7 ± 12.2
g/L and ranged from 93.9 ± 0.8 g/L to 95.1 ± 0.8. After 30 days
of treatment, significant increase in Hb concentration was

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Table 2. Haemoglobin Concentration in g/l (Mean ± SE) of all groups from baseline to end of study
Groups
No.
Day 0
Day 30
Day 60
Day 90
Day 170
Day 270
Starch
185
95.1 + 0.8
94.7 + 0.7
94.5 + 0.7
95.4 + 0.7
94.8 + 0.7
94.7 + 0.7
SR + SC
178
95.0 + 0.9
96.7 + 0.7
99.5 + 0.7**
101.5 + 0.7**
100.6 + 0.7**
99.7 + 0.7**
IFA
166
94.6 + 0.9
95.4 + 0.8
97.5 + 0.7
97.8 + 0.8
97.0 + 0.7
96.1 + 0.7
SR+SC+IFA
168
93.9 + 0.9
98.0 + 0.8*
102.6 + 0.8**
105.6 + 0.7**
105.5 + 0.8**
104.1 + 0.7**
Differs significantly [*p < 0.05; **p < 0.01] as compared to control (group I).
observed in group IV. At the end of treatment period,
significant differences were noted within and amongst all the
treatment groups. Group II (SR 250 mg + SC 400 mg) and
group IV (SR + SC + IFA) were found to be better than the
group III (IFA). However, the increase in Hb levels in group IV
was significantly higher than any other group. At the end of
study period (270 days), the mean gain of Hb level (g/L) in the
three intervention groups II, III, and IV were 4.6 ± 0.4, 1.4 ±
0.3, and 10.1 ± 0.6 g/L, respectively. The maximum gain was
noted in the group IV which was significantly higher than any
other group. At the end of study period, 123 students dropped
out due to various reasons viz. non compliance, parental
objection or lost to follow-up. However, no adverse effect of
the Ayurvedic medication was recorded in any of the
participants.
DISCUSSION
Deficiency of essential micronutrients like vitamin A and iron
is very common in Asia. Iron deficiency anaemia affects 40 -
50% of preschool and primary school children (Khor, 2003). A
very high prevalence of IDA has also been estimated in
adolescents. Literature survey of Srihari et al. indicates that
occurrence of anaemia ranges from 19 to 88% across five
different cities in India (Srihari et al., 2007). According to a
national survey, 79.2% children under 3 years of age and 56.2%
of women (aged 15 - 49) have anaemia (Toteja et al., 2006).
High prevalence of anaemia (around 80.6%) was seen in
adolescent students (Ramachandran P, 1989).
The present study indicated that non iron containing
Ayurvedic formulations Sootshekhar Rasa and Sitopaladi
Churna (250 mg + 400 mg) taken daily along with IFA show
significant improvement in Hb concentration of students.
Participants of both groups treated with SS and IFA also
showed significant improvement in Hb levels, however, the
maximum gain was observed when SS and IFA were given
together. Moreover, a drop in Hb levels was noted in all groups
when the therapy was stopped. In an earlier study, SS was
found to increase Hb levels significantly in non-pregnant
women of reproductive age group (11 - 45 years) (Prakash et al.,
2000). Remarkable increase of Hb levels in adolescent students
was earlier observed with daily dose of SR 250 mg + SC 400
mg (Prakash et al., 2010). Similar trends were also seen in
present study.
A study hypothesis seldom explains the cause of anaemia.
In general, iron deficiency results when iron demands of body
are not met due to insufficient intake, poor absorption, impaired
transport, physiologic losses or chronic blood loss as a result of
disease (De Maeyer et al., 1989). Therefore, diet plays an
important role in restoring iron deficiency. However, Indian
diet predominantly comprises of cereals which are grossly
deficient in protective foods. Serious nutritional inadequacies
results in low birth weight, retarded growth, and nutritional
deficiency (Viteri, 1998). When diet alone cannot restore
deficient iron levels to normal within an accepted frame, iron
supplementation has to be provided (De Maeyer et al., 1989).
Supplemental iron is available in two forms: ferrous and ferric.
Ferrous iron salts are the best absorbed form of iron
supplements. Many studies have suggested that a supplement
administered twice in a week or even once is as effective as
daily supplementation in raising Hb levels (Yip et al., 1988;
Yusufji et al., 1973).
In the past, many daily supplementation programs in
developing countries have been unsuccessful due to lack of
supply and compliance (Galloway and McGuire, 1996).
Despite the efficacy and low cost of the ferrous preparations,
they are associated with side effects such as nausea, epigastric
discomfort, and constipation (De Maeyer et al., 1989).
However, in the present study no notable adverse side effects of
Ayurvedic for ions were noted in any treatment group.
Iron is a component of every living cell and is essential in
the maintenance of health (De Maeyer et al., 1989). It plays a
central role in oxygen transport and cellular energy metabolism.
The significance of ensuring adequate bio available dietary iron
stems from the severe consequences associated with iron
deficiency and anaemia, including reduced immune function
and resistance to infection, formative delays and irreversible
psychological deficiencies in young children, impeded physical
work performance, and adverse pregnancy outcomes (Cooper
et al., 2006). The quantity of bio available iron is important in
diet. This is determined by simulation and inhibitory factors
that exist within a meal (Bothwell et al., 1989). Iron
supplement should be taken with a source of ascorbic acid such
as orange juice as acidic environment facilitates better iron
absorption, whereas, food products containing tannins and
phytates, such as tea, that reduce iron absorption should be
avoided. Also, medicines, such as antacids, proton pump
inhibitors, h-blockers, that raise the gastric pH need to be
avoided (De Maeyer et al., 1989).
The rationale of using non iron Ayurvedic preparations SS
and IFA together was that SS may improve the absorption of
iron in gastrointestinal tract. The result from this present study
indicates maximum gain of Hb was seen among the participants
given SR+SC+IFA. Our present experience and earlier studies
indicate that combination of Sootshekhar Rasa and Sitopaladi
Churna may act as catalyst in iron absorption. This Herbo-
mineral preparation contains Bhasmas of silver, copper,
mercury and many medicinal herbs like Eclipta Alba,
Cinnamomum zeylancia, Zingiber officinale, Piper longum,
Bambusa arumdinaceae, Ellettaria cardamomum and
Cinnamomum cassia etc. and is described for the treatment of
acid refluxes, flatulence, nausea, vomiting, syncope and cough
(Sathya et al., 2009). The author of this study observed the
synergistic effect of these formulations in improving nutritional
anaemia in this clinical practice. Though the consequent control
clinical studies establish prima facia evidences about the
significant improvement of nutritional anaemia by using the
stated Ayurvedic formulations, the real strength of Ayurvedic
formulations in improving iron deficiency remain largely
unknown. There might be many hypothesis or working
mechanisms behind the observed effect which need to be
explored by designing further experimental and clinical studies.

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Adolescence represents a real opportunity to make a
difference in life-long patterns (Kaur, 2006). Though there is
lot of interest globally in adolescent reproductive health and
sexually transmitted diseases, adolescent nutrition has also
aroused little interest (Kurz, 1996). Adolescent girls living in
developing countries like India constitute a vulnerable group;
they get married at an early age and are exposed to greater risk
of reproductive morbidity and mortality. However, little
attention is given towards the nutritional deficiency in
adolescent students. A reason for this inadequate attention may
be reluctance to target a new group when even interventions for
the primary target group, i.e., pregnant women through prenatal
care services, are not functioning adequately. Despite the fact
that this pragmatic concern ought not to be taken lightly, it is
primarily a logistical supply issue deserving reliable
consideration, regardless of additional target group (Kurz and
Galloway, 2000). Evidence suggests that control of anaemia in
pregnant women may be more easily achieved if satisfactory
iron status can be ensured during adolescence (WHO, 1999).
To conclude, different causative factors lead to higher
incidences of anaemia in developing countries (Tolentino and
Friedman, 2007). Nutritional disorders are responsible for most
of mortality and drop outs among adolescent students in India
(Awate et al., 1997). Evidence suggests that preventive
supplements coupled with nutrition education may be a more
effective strategy associated with better compliance and
improvement of iron status (Ahluwalia, 2002). Our study
indicates that there is high prevalence of anaemia in both
school going boys and girls. Adolescent health is the most
important indicator of development of a nation. Hence, urgent
attention is required in this area as proper interventions in
school students have shown to improve anaemia.
The result from our study indicates that non iron Ayurvedic
preparation Sootshekhar Rasa plus Sitopaladi Churna given
along with IFA rather than only IFA might be a more
appropriate combination therapy to improve nutritional
anaemia in adolescents. However, further multi-centric studies
should be carried to assess the exact potential of this
combination.
ACKNOWLEDGEMENTS
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.
Mr. Premchand Godha of Ipca Laboratories Ltd., Mumbai and
Department of AYUSH, Ministry of Health and Family Welfare,
Government of Uttarakhand for providing financial support. Dr.
G.S Toteja Scientist F, Indian Council for Medical Research,
New Delhi, for guidance, study design and arranging
collaboration between VCPCRF and All India Institute of
Medical Sciences, New Delhi, for ensuring quality control,
Department of Health and Education, Government of
Uttarakhand for providing requisite logistic support. Principals
of the schools giving consent for this study. All field workers
and staff of VCPCRF and Mr. Nitin Chandurkar of Ipca
laboratories who helped in the drafting of manuscript.
CONFLICT OF INTEREST
The authors have no conflicting financial interests.
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