This document discusses a comparative clinical study to evaluate the effect of Nishalauha with Ferrous Sulphate in the management of Pandu with respect to Iron Deficiency Anaemia. It provides background on why the topic was chosen, the objectives of the study, and an overview of the planned methodology including a historical review, disease review in Ayurveda and modern literature, drug review, and clinical study. Guidelines for the clinical study are outlined relating to subjects, groups, treatment, and assessment criteria.
Comparative study of Nishalauha and Ferrous Sulphate in Iron Deficiency Anaemia
1. A comparative clinical study to evaluate the effect of
“Nishalauha with Ferrous Sulphate” in the management
of Pandu w.s.r. to Iron Deficiency Anaemia
Co- Guide
Dr. Akhilesh Srivastava
MD (Ayu), PhD
Sr. lecturer
PG Deptt. Of Roga Nidana
Evam Vikriti Vigyana
RGG PG Aurvedic College &
Hospital
Paprola, Distt. Kangra (HP)
Co- Guide
Dr. Seema Shukla
MD (Ayu)
Reader
PG Deptt. Of Prasuti Tantra
Evam Stree Roga
RGG PG Aurvedic College &
Hospital
Paprola, Distt. Kangra (HP)
Guide
Dr. Rajesh Kumar Manglesh
MD (Ayu)
Reader
PG Deptt. Of Roga Nidana
Evam Vikriti Vigyana
RGG PG Aurvedic College &
Hospital
Paprola, Distt. Kangra (HP)
Research Scholar
Dr. Ajay kumar
B.A.M.S. (GRAU)
2.
3. Why Did I Choose
This Topic
Pandu Roga can be clinically correlated
with Anaemia. As in both Pandu Roga and
Anaemia there are similar signs and
symptoms such as pallor, easy fatigability,
decreased appetite, generalized body
aches.
Due to high prevalence in the society and
lack of effective management, the disease
was chosen for study.
4. 1) To evaluate and compare the effect of Nishalauha with Ferrous sulphate
on Pandu (IDA).
2) To explore the literature regarding Pandu in Ayurveda and IDA in modern
literatures.
3) To study the other associated effects of the trial drugs if any.
4) To find the relationship between Deha Prakriti and Pandu Roga.
7. HISTRORICAL REVIEW
Various references related to Pandu has been mentioned in different
literature as follows:
Veda :
In Rigveda and Athervaveda, threre is description of Pandu and its treatment.
Paurana :
Pandu was mentioned in Garuda purana and Agni Purana.
8. Samhita :
Charaka Samhita :
Aacharya Charaka has mentioned Pandu Roga in-
Chikitsasthana 16th Chapter "Pandu Roga Chikitsa."
Sutrasthana Adhyaya 19, "Ashtodariya Adhyaya“.
Described Pandu as feature of various other diseases.
Sushruta Samhita :
Uttartantra Adhyaya 44, “Pandu Roga Pratishedhanam Adhyaya”.
Kashyap samhita :
In Sutrasthana 25
th
chapter “Vedana Adhyaya”.
Harita samhita :
Given specific description of Pandu Roga in 8
th
chapter that is “Pandu Roga
Chikitsa Adhyaya” in 3
rd
Sthana.
11. Pandu
Etymology of Pandu:
Ikk.MqLrq ihŸkHkkxk/kZ% dsrdh /kfwy lfUuHke%A Vachaspatyam
Part-5
Vachaspatya refers Pandu as mixture of white and yellow colour which
resembles with the pollen grains of Ketaki Flower.
Ikk.Mqq% ihŸka laofyr ”kqDyk%A Amarakosha (Bhanu dixit comm.)
Pu.kha.5/13
gfj.k% ik.Mqj% Ikk.Mqq% bZ’kr~ Ikk.MqLrq /kwlj%A Amarakosha
Pu.kha.1/5/343
According to Amarakosha, Pandu means a white colour mixed with
yellowish Tinge.
13. nks’kk% fir ç/kkukLrq ;L; dqI;fUr /kkrq’kqA
lks·YijDrks·YiesnLdks fu%lkj%
f”kfFkysfUæ;%A oSo.;Z Hktrs
Ch.chi.16/4-6
Pandu is a clinical condition characterized by whitish yellow discoloration of skin,
eyes, nails etc. The person with this disease suffers from decrease in Rakta Dhatu
amount, strength and complexion. He becomes Nihsara (loss of natural integrity,
tone and strength of Dhatus).
29. DEFINITION
Anaemia is defined as a haemoglobin concentration in blood below the lower
limit of the normal range for the age and sex of the individual.
Deficiency of haemoglobin in the blood is called Anaemia, which can be caused
by either low red blood cells count or low haemoglobin level in the cells. It can
be found in every class of people.
Anaemia can be temporary or long term and can range from mild to severe.
30. EPIDEMIOLOGY
About half of the world's anemic women live in the Indian subcontinent, and
88% of them develop anaemia during pregnancy.
Asia has the highest rates of anaemia in the world.
In India, Anaemia affects an estimated 50% of the population. In India,
anaemia is considerably high for rural women (54%) than for urban women
(46%).
Deficiency of iron is the most common cause of anaemia worldwide.
31. Etiology
Different types of anaemia have different causes. They includes:
Iron deficiency anaemia: Most common type. Due to deficiency of iron.
Vitamin deficiency anaemia: Diet lacking folate and Vit.B12 and other key
nutrients leads to this type of anaemia.
Aplastic anaemia: Due to infection, medication, autoimmune disorder, exposure
to toxic substances body unable to produce RBCs in adequate number.
Hemolytic anaemia: Increase destruction of RBCs.
Sickle cell anaemia: Due to defects in haemoglobin.
32. Signs and Symptoms of Anaemia
Weakness
Easy fatiguability
Dysponea on exertion
Tachycardia
Pallor of skin, mucous membranes and sclerae
Palpitations
Unusual dietary cravings such as pica
35. Morphologic classification
Based on the red cell
size, haemoglobin
content and red cell
indices, anaemias
are classified into 3
types :
i. Microcytic,
hypochromic –
MCV,MCH, MCHC
are all reduced
i.e. iron
deficiency
anaemia
ii. Normocytic,
normochromic
iii. Macrocytic,
normochromic
36. Normal Reference Values In Hematology
Men Women
Hemoglobin (g/dl) 14-17.4 12.3-15.3
Hematocrit (%) 42-50% 36-44%
RBC Count (106/mm3) 4.5-5.9 4.1-5.1
Reticulocytes 1.6 +_0.5% 1.4+_0.5%
WBC (cells/mm3) ~4000-11000
MCV (fl) 80-96
MCH (pg) 30.4+_2.8
MCHC (g/dl) 34.4+_1.1
RWD (%) 11.7-14.5
38. Causes of Iron Deficiency
1. Increased Iron Utilization
Postnatal Growth
Adolescent Growth
Erythropoetin Therapy
2. Physiologic Iron Loss
Menstruation
Pregnancy
39. 3. Pathologic Iron Loss
GIT Bleeding
Genitourinary Bleeding
Intravascular Hemolysis
4. Decreased Iron Intake
Cereal rich diet
Pica, Malabsorption
Acute and Chronic Inflammation
40. Iron Metabolism
Iron taken in diet is absorbed at all parts of GIT especially duodenal
mucosa.
Acid medium favours iron absorption.
Only 10% of the ingested iron is absorbed.
Normal serum iron level is 50-150 mg/dl.
Iron absorption is increased in – ferrous state, increase erythropoiesis.
41. Iron stored as ferritin and hemosiderin. In men, storage compartment
contains about 1000 mg of iron and in women, it ranges from 0-500
mg.
Iron is transported after binding with transferrin, contain 3 mg of
iron.
1 mg elemental iron is lost from shedding of senescent cells of GIT
and Genitourinary tract and desquamation of skin.
43. Diagnostic features of iron deficiency
Haemoglobin Variably reduced
Mean cell volume Reduced
Erythrocyte count Normal or reduced less than Hb level would suggest
Blood film Hypochromia, microcytosis, oval and elliptical
cells, poikilocytes in more severe cases.
Leucocyte count differential Normal
Platelet count Normal or raised
Bone marrow iron store Empty
Plasma transferrin Raised
Plasma iron Reduced
Serum ferritin Reduced
44.
45. Differential Diagonosis
Megaloblastic Anaemia:
Megaloblastic anaemia is characterized by asynchronous nuclear and cytoplasmic
maturation in all myeloid and erythroid cell lines.
It is due to aberrant DNA synthesis as a result of single or combined deficiency of
either Vit.B12 or folate. In deficient state of both these MCV will be <110.
Average daily diet contain 5-30 microgram of Vit.B12 . Daily requirement is about
1 microgram. Source of Vit.B12 is bacteria and animal tissue.
Leafy vegetables, fruits, animal products are rich source of folate. Normal
requirement is 100цg/day. Total body storage capacity is up to 15mg. Serum level
of folate is 5-20 ng/dl. Absorbed mainly in jejunum. Most dietary folate is
present as polyglutamates.
46. Metabolism of Vit.B12
Ingested
food
Release
Vit.B12 at
gastric pH
& binds
with
carrier R
protein
At
pancreatic
pH Vit.B12
release
from R
protein &
bind with
IF
Vit.B12 +
IF complex
binds to
specific
receptors
in the
terminal
ileum
Vit.B12 is
actively
transported
by
enterocytes
to plasma
From
enterocytes
Vit.B12 is
transported
by
transcobala
min-II to
liver for
tissue
utilization.
48. Pernicious Anaemia
This is an autoimmune disorder in which the gastric mucosa is atrophic, with loss
of parietal cells causing IF deficiency.
Finding of Anti IF antibody in the context of Vit.B12 defieciency is diagnostic of
pernicious anaemia.
Antiparietal cell antibodies are present in over 90% of cases but are also present
in 20% normal cases.
Schilling test is performed to differential diagnosis the cause of Vit.B12
deficiency.
49. Finding in Megaloblastic anemia
Haemoglobin often reduced, may be very low
Mean cell volume Usually raised, commonly >120 fl
Erythrocyte count Low for degree of anaemia
Blood film Oval macrocytosis, poikilocytosis, red cell
fragmentation, neutrophil hyper segmentation
Reticulocyte count Low for degree of anaemia
Leucocyte count differential Low or Normal
Platelet count Low or Normal
Bone marrow Increased cellularity, Megaloblastic changes in the
erythroid series, giant metamyelocytes, dysplastic
megakaryocytes, increased iron in stores, pathological
non-ring sideroblasts
Serum ferritin Elevated
Plasma lactate dehydrogenase Elevated often markedly
50. Anaemia of Chronic disease (ACD)
Also called as simple anaemia
This is mild and non progressive anaemia, occurring over a period of 3-4
weeks.
ACD is most often associated with chronic infection, inflammatory diseases,
trauma and neoplastic diseases.
Anaemia is normocytic normochromic (most commonly) or microcytic
hypochromic.
51. Immune Hemolytic Anaemia
Hemolysis due to immune mechanism occurs when antibody and /or complement
bind to red cell membrane.
Destruction of RBCs usually occurs by type II (Cytotoxic) hypersensitivity reaction.
Usually acute, often with jaundice.
Classified into autoimmune type and drug-induced type.
52. Special cases of
hemolytic anaemia:
Glucose- Phosphate
Dehydrogenase deficiency –
more common in Mediterranean
and African population. Lack of
RBC enzyme makes cell very
sensitive to oxidative stress.
Sickle cell disease – results due
to a single glutamic acid to valine
substitution at of the beta globin
polypeptide chain. Abnormal
haemoglobin causes change in RBC
shape, resulting in constant RBC
destruction by the spleen.
53. Thalassemias
Decreased production of normal
haemoglobin polypeptide chains.
Classified according to
haemoglobin chain that is affected
( Alpha, Beta, Gamma, Delta ).
Common, variable severity of
hemolysis.
Characterized by hypochromic
microcytic red cells ( MCV
markedly decreased while MCHC
only slightly decreased )
61. Inclusion Criteria
Exclusion Criteria
Patients having Hemoglobin
level 8 to 11 gm%.
Patients of either sex
between 12 to 60 years.
Blood picture presenting
either microcytic
hypochromic or normocytic
hypochromic anaemia.
In pregnancy after 1st
trimester.
Patients having Hemoglobin level
less than 8 gm% and more than 11
gm%
IDA resulting from acute or chronic
blood loss.
Patients showing allergy to the
trial drug .
Sideroblastic anaemia,
Thalassemia major and minor.
Anaemia in association with other
systemic disorders which
interferes with the prognosis and
treatment of the case.
62. GROUPING OF PATIENTS
There were two trial groups with 20 Patients in each trial group .
Dose of formulation / administration
– Group 1- In this group each subject was given 500 mg tab of Nishalauha once
daily.
Group II- In this group each subject was given 200 mg tab of Ferrous Sulphate once
daily.
Anupana
Madhu and Go Ghrita
Total Duration of study-30 days
Follow up- after 15 days
63. CRITERIA OF ASSESSMENT
CLINICAL ASSESSMENT
SYMPTOM GRADES SCORE
Daurbalyata- Not present 0
After heavy work relieved soon and patient tolerates 1
After moderate work relived later and patient tolerates 2
After little work relived later 3
After little work relieved later but beyond tolerance 4
Daurbalyata even in resting condition 5
Hridspandanam- Not present 0
After heavy work relieved soon and patient tolerates 1
After moderate work relived later and patient tolerates 2
After little work relived later 3
After little work relieved later but beyond tolerance 4
Hridaspandanam even in resting condition 5
64. SYMPTOM GRADES SCORE
Bhram- Not present 0
After heavy work relieved soon and patient tolerates 1
After moderate work relived later and patient tolerates 2
After little work relived later 3
After little work relieved later but beyond tolerance 4
Bhrama even in resting condition 5
Rukshata
In Twaka, Nakha, Netrav
artma, Jivha, Hastapada
Not present 0
In any two of these 1
In any three of these 2
In any four of these 3
In all 4
65. SYMPTOM GRADES SCORE
Sramajanya
Shawas-
Not present 0
After heavy work relieved soon and patient tolerates 1
After moderate work relived later and patient tolerates 2
After little work relived later 3
After little work relieved later but beyond tolerance 4
Shawas even in resting condition 5
Hatanal- Good appetite 0
Patient takes meals 3times/ day with little desire 1
Patient takes meals 2times/day with little desire but not associa
ted with nausea and vomiting
2
Patient takes meals 2times/day with little desire but associated
with nausea and vomiting
3
No desire to take meals 4
66. SYMPTOM GRADES SCORE
Shram-
No feeling of fatigue and weakness on doing any work 0
No feeling of fatigue and weakness on doing accustomed work 1
Feeling of fatigue and weakness on doing accustomed work 2
Feeling of fatigue and weakness on doing less than accustomed
work
3
Feeling of fatigue and weakness even at rest 4
Gatrashoola- Absent 0
Mild and occasional 1
Moderate and often 2
Severe and constant 3
67. SYMPTOM GRADES SCORE
Karana kshweda
(Tinnitus)-
No abnormal sounds in ear 0
Occasional low frequency sound in ears 1
Occasional high frequency sound in ears 2
Constant low frequency sound in ears 3
Constant high frequency sounds in ears 4
Twak Panduta- Not present 0
Mild pallor 1
Moderate pallor 2
Whitish pallor 3
71. age WISE DISTRIBUTION
0
2
4
6
8
10
12
14
16
16-20 21-30 31-40 41-50
Age wise distribution of 40 patients
Series1 Series2
Age in Years No of Patients Total Percentage
Group-I Group-II
16-20 2 4 6 15
21-30 14 12 26 65
31-40 4 4 8 20
41-50 0 0 0 00
72. sex WISE DISTRIBUTION
0
5
10
15
20
25
GROUP 1 GROUP 2
Sex wise distribution of 40 patients
Male Famale
Sex No of Patients Total Percentage
Group-I Group-II
Male 0 2 2 5
Female 20 18 38 95
73. religion WISE DISTRIBUTION
0
5
10
15
20
25
GROUP 1 GROUP 2
Religion wise distribution of 40 patients
Hindu Other
Religion No of Patients Total Percentage
Group-I Group-II
Hindu 19 20 39 97.5
Other 01 0 01 2.5
74. occupation WISE DISTRIBUTION
0
1
2
3
4
5
6
7
8
9
10
Student Private job Govt. Job Housewife
Occupation wise distribution of 40 patients
GROUP 1 GROUP2
Occupation No of Patients Total Percentage
Group-I Group-II
Student 8 5 13 32.5
Private job 4 5 9 22.5
Govt. Job 0 1 1 2.5
Housewife 8 9 17 42.5
75. marital status WISE DISTRIBUTION
0
2
4
6
8
10
12
14
16
GROUP 1 GROUP 2
Marital status wise distribution of 40 patients
Unmarried Married
Marital Status No of Patients Total Percentage
Group-I Group-II
Unmarried 8 6 14 35
Married 12 14 26 65
76. Edu. qualification WISE DISTRIBUTION
0
2
4
6
8
10
12
Illiterate Under matriculation Matriculation Graduate Post Graduate
Education qualification wise distribution of 40 patients
GROUP 1 GROUP 2
Education No of Patients Total Percentage
Group-I Group-II
Illiterate 0 0 0 0
Under matriculation 3 2 5 12.5
Matriculation 3 7 10 25
Graduate 10 9 19 47.5
Post Graduate 4 2 6 15
77. socioeconomic status WISE DISTRIBUTION
0
2
4
6
8
10
12
14
16
18
High Middle Poor
Socioeconomic status wise distribution of 40 patients
GROUP 1 GROUP2
Socio Ecnomic
Status
No of Patients Total Percentage
Group-I Group-II
High 2 2 4 10
Middle 17 17 34 85
Poor 1 1 2 5
78. addiction WISE DISTRIBUTION
0
2
4
6
8
10
12
14
16
Tea/coffee Smoking Alcohol No addiction Other
Addiction wise distribution of 40 patients
GROUIP 1 GROUP 2
Addiction No of Patients Total Percentage
Group-I Group-II
Tea/coffee 15 13 28 70
Smoking 0 0 0 0
Alcohol 0 0 0 0
No addiction 5 7 12 30
Other 0 0 0 0
79. dietetic habits WISE DISTRIBUTION
0
2
4
6
8
10
12
14
16
18
GROUP 1 GROUP 2
Dietetic habits wise distribution of 40 patients
Vegetarian Mixed
Dietetic habits No of Patients Total Percentage
Group-I Group-II
Vegetarian 3 7 10 25
Mixed 17 13 30 75
80. jarana Shakti WISE DISTRIBUTION
0
2
4
6
8
10
12
14
Visham Sama Tikshana Mridu
Jarana Shakti wise distribution of 40 patients
No of Patients Group-I No of Patients Group-II
Jarana Shakti No of Patients Total Percentage
Group-I Group-II
Visham 1 1 2 5
Sama 7 6 13 32.5
Tikshana 0 0 0 0
Mridu 12 13 25 62.5
87. EFFECT OF NISHA LAUHA ON HAEMOGLOBIN
Hb N Mean Score Diff %age
Relief
S.D S.E T P
BT AT
No. of
Patients
18 9.789 11.367 1.578 16.12% 1.057 0.249 6.330 <0.001
GROUP 1
9
9.5
10
10.5
11
11.5
BT AT
88. EFFECT OF FERROUS SULPHATE ON HAEMOGLOBIN
GROUP 2
Hb N Mean Score Diff %age
Relief
S.D S.E T P
BT AT
No. of
Patients
18 10.267 11.900 1.633 15.90% 0.827 0.195 8.382 <0.001
9
9.5
10
10.5
11
11.5
12
12.5
BT AT
89. Intergroup comparison of effect of therapy on HAEMOGLOBIN
Group Mean Diff. % age relief SD T P
I 1.578 16.12 1.057 0.176 0.862
II 1.633 15.90 0.827
15.75
15.8
15.85
15.9
15.95
16
16.05
16.1
16.15
GROUP1 GROUP 2
90. EFFECT OF NISHA LAUHA ON S. FERRITIN
S.
FERRITIN
N Mean Score Diff %age
Relief
S.D S.E T P
BT AT
No. of
Patients
18 52.446 100.879 48.434 92.35 20.713 4.882 9.921 <0.001
0
20
40
60
80
100
120
BT AT
91. EFFECT OF FERROUS SULPHATE ON S. FERRITIN
S.
FERRITIN
N Mean Score Diff %age
Relief
S.D S.E T P
BT AT
No. of
Patients
18 62.133 98.906 36.772 59.18 20.540 4.841 7.595 <0.001
0
20
40
60
80
100
120
BT AT
92. Intergroup comparison of effect of therapy on S. FERRITIN
Group Mean Diff. % age relief SD T P
I 48.434 92.35 20.713 1.696 0.099
II 36.772 59.18 20.54
0
10
20
30
40
50
60
70
80
90
100
GROUP 1 GROUP 2
93. Comparison of Overall Effect of
Therapy in Both Groups
Results Group I (n=18) Group II(n=18)
No. of
Patien
ts
%age No. of
Patients
%age
Markedly
Improved
(76%-100%)
15 83.33% 1 0.05%
Moderately
Improved
(51-75%)
2 11.11% 7 38.88%
Mildly
Improved
(25-50%)
1 0.05% 10 55.55%
No
improveme
nt (<25%)
0 0 0 0
0
2
4
6
8
10
12
14
16
Markedly Improved
(76%-100%)
Moderately
Improved (51-75%)
Mildly Improved
(25-50%)
No improvement
(<25%)
GROUP 1 GROUP2
97. Anaemia is very common in India and Iron deficiency anaemia is the most
common deficiency all over the world.
40 random anaemic patients were taken in this clinical study in which
maximum patients were having the Roop and Poorvroopa which are
mentioned in Ayurvedic classics.
Among the 40 patients 4 were drop out.
In remaining 36 patients, 15 were markedly improved in group 1 and 1 was
markedly improved in group 2, 2 were moderately improved in group 1 and 7
were moderately improved in group 2.
98. The present clinical study indicates that the herbomineral formulation
“Nishalauha” is an effective, well tolerated, clinically safe and better
alternative for Ferrous Sulphate which is having some adverse effects in the
management of Iron Deficiency Anaemia.
No major unpredictable effect of therapy was observed during the entire trial
period.
However, this study was a humble attempt in small number of patients and in
a fixed duration of time thus requires further study on large sample for longer
duration to prove its beneficial effects on patients.
99. Acknowledgement
At the time of accomplishment, I want to express my sincere and deepest sense of gratitude
and heartfelt regard to my Guide Dr. Rajesh Manglesh and co-guides Dr. Akhilesh
Srivastava , Dr. Seema Shukla and worthy teacher of our depatment Dr Swapnil Saini
for their constant encouragement, vision, motivation and blessings.
My heartiest gratitude to respected principal Prof. Vijay chaudhary sir and all the
respected Teachers of RGGPG Ayurvedic College for their guidance and love.
100. I am thankful to all my colleagues, seniors and juniors for their valuable support and
love.
Laboratory staffs of RGGPG Ayurvedic Hospitals for their co-operation during the
trial period.
All the officials and working staffs of Charak Ayurvedic Pharmacy.
Editor's Notes
Classical triad of IDA, Dysphagia and esophageal webbing.