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INDIAN JOURNAL OF APPLIED RESEARCH X 205
Volume : 4 | Issue : 3 | Mar 2014 | ISSN - 2249-555X
RESEARCH PAPER
Healthcare
Quantification of Immunity Status of Dabur
Chyawanprash - A Review Part- 2 (Clinical Studies)
Dr. J. L. N. Sastry Dr. Arun Gupta
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Dr. N.B. Brindavanam Dr. Satyajyoti Kanjilal
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Mr. Satyendra Kumar Dr. Manju Setia
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Dr. Sasibhushan Vedula Dr. Ruchi Srivastava
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
Healthcare Research, Dabur Research & Development
Centre (DRDC), Dabur India Limited,
22, Site IV, Sahibabad (Ghaziabad), UP 201010, India.
KEYWORDS
Dabur Chyawanprash, Immunity, Nasal Allergy, Viral Infections, Quality of Life, Seasonal
influences, Beneficial Effects
ABSTRACT Ayurveda, the oldest Indian system of medicine, recommends the administration of a specified group of for-
mulations known as Rasayana for preventing occurrence of diseases. Ayurvedic scholars like Caraka (500 BC)
have mentioned that, the use of Rasayana would impart a long, healthy and a disease free life while promoting intelligence,
memory and lustre. Chyawanprash (CP) is a well-known Ayurvedic Rasayana formulation and studies have indicated that
they act as immunomodulators. In review part - 1, experimental studies (in vivo and in vitro), conducted by Dabur Research
and Development Centre in evaluating the immunity benefits of Dabur Chyawanprash were reviewed. In the present review,
Clinical Studies on Dabur Chyawanprash in establishing its beneficial effects on immunity have been reviewed. The criteria
of assessment in the clinical studies was based on clinical symptoms, IgE, IgG, C3, C4, respiratory performance test, plasma
cortisol levels and haematological parameters.
INTRODUCTION
Chyawanprash (CP) is a well-known Ayurvedic formulation,
which is being used time immortal for rejuvenation and im-
mune boosting effects on the human body. It is claimed to be
useful in reducing the effects of ageing and to provide resist-
ance against diseases1-3 CP is made up of more than forty
five Ayurvedic ingredients where Amla (Emblica officinalis)
is the main ingredient which confers significant antioxidant
property to CP4. The other important constituents such as
Guduci (Tinospora cordifolia) in the formulation have exhib-
ited immunomodulatory activities in experimental models5.
The immunologic causes of allergic rhinitis underscore the
important roles of both adaptive and innate immune sys-
tems. In recent years, appreciation of the role of nasal innate
immunity has grown and evidence suggests that the patho-
genesis of allergic rhinitis is partially mediated by the innate
immune system. Beneficial effects of Dabur Chyawanprash
(DCP) have also been observed on nasal allergies and viral
infections and seasonal influences. There, as such, exists a
battery of evidence suggesting its multi faceted biological
activity in favour of positive health.
Dabur Chyawanprash (DCP) is a time-tested immunity boost-
er, which is being manufactured following the traditional
methods for more than 60 years. There are several preclini-
cal6 as well as clinical observations documented over the last
3
fifty years mostly on the immunity benefits of DCP. Recently,
in a study to evaluate the toxicity reduction and early resto-
ration by adjunct therapy of Ayurvedic drugs by increasing
the bio availability of Anti Tubercular Therapy (ATT) in pa-
tients of pulmonary tuberculosis (PTB), adjunct therapy with
DCP at doses 10mg/kg given orally thrice a day for 28 days
produced appreciable changes in IgA and IgM patterns as
compared to ATT given alone and with other drugs as add
on therapy and in abating symptoms of PTB such as ano-
rexia, cough with expectoration, weakness and generalized
improvement in health. Dabur Research and Development
Centre (DRDC) has conducted several pre-clinical and clinical
studies on DCP. In the previous paper published in Indian
Journal of Applied Research, February 2014 issue, preclini-
cal studies in evaluating the immunomodulatory activity of
DCP were reviewed. In the current paper, a review is being
made covering the clinical studies which were instrumental in
establishing the immunity status of subjects who consumed
DCP.
1. AIMS AND OBJECTIVES
In this series of review (Part 2), it is intended to analyze the
quantification of immunomodulatory benefits of DCP on Im-
mune Status and/or Quality of Life in the subjects consuming
DCP.
206 X INDIAN JOURNAL OF APPLIED RESEARCH
Volume : 4 | Issue : 3 | Mar 2014 | ISSN - 2249-555X
RESEARCH PAPER
2. LITERARY SEARCH ON CLINICAL STUDIES ON DCP
DCP has been studied in various clinical studies, some of
them are listed below:
a. Effect of DCP on seasonal influences – Ojha J K et al.,
19987,
b. Adaptogenic properties of DCP – Singh R H et al., 19988
c. Effect of DCP on Nasal Allergies and Infections – Jaggi
O P., 19999
d. Effect of Chyawanprash and Vitamin C on Glucose toler-
ance and Lipo protein profile – Manjunath et al., 200110
e. Chyawanprash Awaleha: a genoprotective agent for bidi
smokers – Yadav et al., 200311
f. Adjunct therapy of Ayurvedic medicine with anti tubercu-
lar drugs on the therapeutic management of pulmonary
tuberculosis - P. K. Debnath et al., 201212
Out of the above study the following two clinical studies,
which are directly linked to immunomodulatory activity of
DCP are being critically reviewed In this paper.
• Effect of DCP on Nasal Allergies and Infections – Jaggi
O P, 9 New Delhi
• Effect of DCP on seasonal influences – Ojha J K et al7
IMS, BHU
I. Effect of DCP on Nasal Allergies and Viral Infections
The study reviwed is Open Label and was conducted on DCP
to evaluate the immunity enhancement activity of DCP and
its role in respiratory health (recurrent cough and cold).
Main features for identifying causative factors of recurrent
cough & cold were a) allergy (history and/or other manifesta-
tions of allergy), diagnosis of allergic manifestation is on the
criteria of Increase of eosinophil cells in the nasal secretions
and blood, Increase in serum IgE levels. b) Viral: History of
viral infection in the throat occurring in many people at a time
and confirmed by absence of pyogenic bacteria in the throat
swab culture. c) Bacterial: Sputum culture positive to patho-
genic bacteria.
MATERIAL & METHODS
The study drug was provided by Dabur India Limited (DIL),
No. 22, Site IV, Sahibabad, Ghaziabad-201010, India. Sub-
jects attending OPD of chest and allergy center, New Delhi
were included in the study after considering inclusion and ex-
clusion criteria. Inclusion criteria (age between 5 – 75 years,
history of allergy, history of recurrent viral infections in throat
and subjects with recurrent bacterial infection) and Exclusion
criteria ( subjects with serious systemic disorders, subjects
suffering from tuberculosis, chronic illness and subjects par-
ticipating in any other clinical trial).
Each study group comprised 10 patients each of either sex
(n=40) in the age group of 16-65 years out of which 29 were
male and 11 were female. Recruited subjects were differenti-
ated in to the following categories viz., (1) Normal (2) Allergy,
(3) Viral infections and (4) Bacterial infections Groups. DCP
(12 g) was given orally two times a day for 12 weeks to re-
cruited subjects. Observations were recorded on each case
at the base line, after 6 weeks and 12 weeks of study period.
Quantitative measurement of total human IgE in serum was
done using UBI MAGIWALTM IgE Quantitative HP-801 solid
phase enzyme-linked immunosorbent assay (ELISA KIT). The
readings were taken using ‘Medilisa 318 Plus’ Elisa reader.
IgG, C3 and C4 estimation in the serum (quantitative) was
done by immunoturbidimetric analysis using Elitech Test Sys-
tem. All other tests were done using standard techniques.
All laboratory investigations were undertaken at independ-
ent labs.
OBSERVATIONS and RESULTS
Following observations were made in the respective groups:
Sputum Culture Test Results: The sputum of recruited sub-
jects in the bacterial group was cultured to detect and identi-
fy the bacteria that infected the lungs or breathing passages.
Most of the respiratory tract bacterial infections are caused
by Penumococus, Staphylococcus aureus, Coliform bacilli,
Pseudomonas aeruginosa, Candida albicans and Aspergillus
fumigates. The present study showed a maximum of Pseu-
domonas infections followed by Klebsiella, Staphylococcus,
E. coli and Streptococcus infections.
Effect on Haemoglobin Levels: Haemoglobin increased in
all groups except in the normal group. The decrease in nor-
mal group was largely due to one person wherein haemoglo-
bin fell considerably Table 1.
Table 1: Showing % change in Haemoglobin (in gm %)
Levels
Group Initial At 6
wks At 12
wks In-
creased De-
creased %
change
Normal 13.29 13.02 12.09 4 6 -2.9%
Allergic
12.63
12.76
12.92
6
4
+1.70%
Bacte-
rial 12.71 12.62 12.89 6 4 +0.40%
Viral 11.95 12.74 12.83 7 3 +7.40%
Total 23 17
Effect on ESR: ESR is known to increase in infections. It was
observed that after taking DCP, ESR fell significantly in nor-
mal group, allergic and viral groups. ESR increased slightly
in the bacterial group (Table 2).
Table 2: Showing % change in ESR (in mm) Levels
Group Initial At 6
wks At 12
wks In-
creased De-
creased %
change
Nor-
mal
20.9 19.3 15.8 2 8
- 24.4
%
Aller-
gic 14.6 10.7 10.1 4 6 -30.8 %
Bacte-
rial 20.6 22.7 21.9 5 5 + 6.3%
Viral 17.7 13.3 13.1 1 9 -25.9%
Total 12 28
Effect on Serum Albumin and Globulin and the Albumin
Globulin Ratio: Estimation of serum albumin determines if
a patient has liver disease or kidney disease, or if the body
is not absorbing enough protein. Serum globulins are a het-
erogeneous group of proteins which include alpha and beta
globulins as well as serum immunoglobulin (which account
for the gamma fractions). Serum globulin was found to in-
crease in all the study groups; maximum being in the bacte-
rial group and minimum in the Allergic group. In the normal
group, there was very little increase. Total serum proteins in-
creased in all groups with maximum and minimum increase in
the Bacterial and Allergic groups, respectively.
The Albumin/globulin ratio showed a decrease in all the
groups of patients. The decrease was due to rise in levels
of serum globulins. Albumin/globulin ratio showed increase
only in the normal groups. Serum protein values and its vari-
ous fractions or ratios before and after giving DCP did not
indicate any particular trend in the immune status.
Effect on IgE Levels: Base-line IgE was maximum in the Al-
lergic group; minimum in the viral group. In all groups, a
definite decrease was noticed after taking DCP. Maximum
decrease occurred in Allergic and in Normal groups. Fur-
thermore, it was also observed that administration of DCP
INDIAN JOURNAL OF APPLIED RESEARCH X 207
Volume : 4 | Issue : 3 | Mar 2014 | ISSN - 2249-555X
RESEARCH PAPER
was helpful in decreasing the elevated levels of IgE in 30 out
of 40 subjects. Decrease in IgE lessens the tendency to de-
velop an allergic reaction (Table 3).
Table 3: Showing % change in IgE (in IU/ml) Levels
Group Initial At 6
wks
At 12
wks
In-
creased
De-
creased
%
Change
Normal 181.1 106.4 90.7 0 10 -49.9%
Allergic 215 150.4 115.5 2 8 -46.3%
Bacte-
rial
105.7 115.2 96.4 4 6 -8.8%
Viral
79.5
67.6
86.6
4
6
-3.0%
Total 10 30
IgG levels decreased in all groups except the Viral. Decrease
was significant only in the Bacterial group. IgG is the pre-
dominant antibody in the serum and it carries the major
burden of neutralizing bacterial toxins and binding to micro-
organisms to enhance their phagocytosis. Statistically signifi-
cant lower levels of IgG antibody in the Bacterial group after
taking DCP could be because of lesser bacterial stimulus
to the production of IgG antibody (Table 4). Intake of DCP
probably reduced the number of bacteria which could stimu-
late IgG production and hence resulted in lower IgG levels.
This could be further substantiated by subsequent studies on
bacterial colony counts after taking DCP
Table 4: Showing % change in IgG (in mg/dl)) Levels
Group Initial At 6
wks At 12
wks In-
creased De-
creased %
change
Normal 1761.9 1706.4 1537.3 5 5 -12.7%
Allergic 1617.6 1662.2 1648.2 5 5 -1.9%
Bacterial 1884.1 1494.6 1434.2 4 6 -23.9%
Viral 1667.5 1721.2 1695.4 6 4 +1.7%
Effect on C3 and C4 Levels: The complement system is a
cascading series of plasma enzymes and proteins capable of
cell lyses. Activation of the classic complement pathway via
C1, C4 and C2 and activation of the alternative complement
pathway via factor D, C3 and Factor B ultimately leads to cell
lyses. C3 and C4 levels thus indicate the function of the two
arms of the complement pathway. The pivotal compound in
this pathway is C3 which splits to form C3b and is necessary
for activation of component C5 – C9 which cause lyses of
the cells.
A decrease in serum C3 levels was noted in all the groups.
A decrease in C4 was noted in all groups of recurrent cough
and cold, but not in the normal group. In the bacterial group,
9 out of 10 showed decrease in C3 and 8 out of 10 in C4 (Ta-
bles 5 & 6). A decrease in C3 and C4 following administration
of CP would indicate a lesser activation of the complement
pathway. This would indicate less cellular destruction and an
overall healthy individual.
Table 5: Showing % change in C3 Levels (in mg/dl)
Group Initial At 6
wks
At 12
wks
In-
creased
De-
creased
%
change
Normal
289.4 226.7 130.5 5 5 54.9%
Allergic 225.2 171 168.6 3 7 -24.0%
Bacte-
rial 330.5 243.5 220.5 1 9 -32.7%
Viral 234.1 197.3 189.3 4 6 -19.1%
Table 6: Showing % Improvement in C4 Levels (in mg/dl)
Group Initial
At 6
wks
At 12
wks
In-
creased
De-
creased
%
change
Normal
17.6 43.2 43.7 8 2 +
148.3%
Allergic 45.5 27.5 28.1 3 7 -38.2%
Bacte-
rial 62.1 52.1 48.3 2 8 -22.2%
Viral 45.2 36.7 35.5 4 6 -21.5%
Effect of DCP on improving the Quality of Life Index (QLI):
The QLI increased in all the groups. Maximum increase was
in the Allergic group. Maximum benefit perceived was in the
physical symptoms aspect of QLI. Benefit in affective prob-
lems was also there. No significant change was observed in
social dysfunction and ego problems. Increase in different pa-
rameters was observed in all the groups. Maximum increase
was observed in Normal and Allergic groups. Minimum in-
crease was found in Bacterial and Viral groups (Table 7).
Table 7: Showing the Improvement in Quality of Life Index in DCP Consumers
Group Before After 12 weeks % change Over-
all %
Change
P C A S P C A S E P C A S E
Normal 76 81.7 71.4 80.5 71.4 79.4 82.8 79.4 80 73.1 +4.5 +1.3 - 11.2 -0.1 +2.4 +3.6%
Allergic 59.2 66.4 61.6 61.6 67.4 63.2 69.6 65.6 64 68.8 +6.8 +4.8 +6.5 +3.9 +2.4 +4.81%
Bacterial 50.3 57.1 52 56 57.1 56 57.7 54.3 53.1 57.1 +11.4 1.00% +4.4 -5.1 +1.0 +2.30%
Viral 76 66 64.7 61.3 65.3 81.3 59.3 65.3 70 65.3 +7.0 -10.1 +3.9 +3.9 Nil +1.57%
(P=Physical problems, C=Cognitive problems, A=Affective problems, S=Social dysfunction, E=Ego problems), Expressed out of
a max 100)
2. Seasonal Effect of DCP on Seasonal Influences Over General Health:
The study was Double-Blind Placebo Controlled clinical study which was conducted on Dabur Chyawanprash (DCP) to establish
208 X INDIAN JOURNAL OF APPLIED RESEARCH
Volume : 4 | Issue : 3 | Mar 2014 | ISSN - 2249-555X
RESEARCH PAPER
its effectiveness in health status throughout the year, in all
seasons, involving, summer, rains, winter and the months fall-
ing in between these seasons.
OBJECTIVE:
The objective of this study was:
1. To elicit beneficial and/or adverse effect(s) of Dabur
Chyawanprash when used throughout the year.
2. To evaluate the clinical efficacy of Dabur Chyawanprash
in subjects having non-specific ailments due to the sea-
sonal influences (with no underlying organic disease).
MATERIAL & METHODS
The samples (both the trial drug and placebo) required for the
study were provided by Dabur India Limited (DIL), No. 22, Site
IV, Sahibabad, Ghaziabad-201010. India, placed in similar con-
tainers with computer generated mock-up labels, in codified
manner to blind the investigator, as well as the user.
Patients attending the OPD of the Department of Dravya-
guna and Department of Medicine, Institute of Medical Sci-
ences, BHU, were enrolled for the study, after an adequate
pre-screening for inclusion and exclusion criteria. Patients
meeting the following inclusion/exclusion criteria were en-
rolled in the study.
Inclusion & Exclusion criteria
Inclusion Criteria:
• Men or women aged between 15-75 years, having no
chronic organic disease.
• Patients complaining of non-specific clinical symptoms
like, loss of appetite, loss of weight, fatigue, weakness,
malaise, recurrent attacks of cold/allergies, running nose,
fever, sleeping abnormal, muscle pain, joint pain, perspi-
ration etc.
Exclusion Criteria:
• Patients having chronic respiratory problems like tuber-
culosis and lung cancer were excluded from the scope of
study on ethical grounds
• Patients with chronic indigestion or with history of gastric
ulcers were excluded from the study
• Patients having any systemic disease like diabetes, renal
impairment any serious from of cardiovascular problem
and liver afflictions were excluded from the study
• Pregnant women were excluded from the scope of the
study.
Effect of DCP on seasonal influences over general health was
an elaborate study stretched over two years covering sum-
mer, rainy and winter seasons.
Two summer seasons, that of 1999 and 2000 was covered
in this trial. The recruitment of the patients was initiated at
the beginning of the month of April and was stopped by the
end of April in order to complete 3 months therapy of the
participants in the summer season itself. Similarly, two rainy
seasons, those of 1998 and 1999, were covered. The recruit-
ment was initiated at the 3rd week of the month of June up to
1st week of July, so as to cover a 3 months therapy period in-
volving the rainy season as well as a complete follow-up. The
winter study fragment involved the winter seasons of 1998
and 1999. The recruitment of the patients for the purpose of
the trial was initiated mid November, which was stopped No-
vember end. The participants received 3 months of therapy
over the winter season with regular follow-up.
A separate round-the-year group covered the patients who
did not fall in the summer, rainy or winter group recruitment
period, but were falling in time period between the recruit-
ment phase of two different seasons and were visiting the
O.P.D. Whereas each season covered 3 months of therapy.
The round-the-year group covered a full year of therapy pe-
riod and follow-up.The eligible patients were assigned to
treatment with the trial drugs, CP- A or the CP-B, by means of
an alternate drug allocation. The trial drug and the placebo
were decoded at the end of the study as
• CP- A - Dabur Chyawanprash
• CP- B - The Placebo
Dosage: The Dose administered in both the study groups
was 12 gms (equal to 1 spoon) twice a day.
Criteria of Evaluation:
Efficacy evaluation was done based on both subjective and
objective criteria at the Baseline i.e., at the start of the thera-
py and at the end of 3 months of drug therapy. In round-the
-year group however there were three regular quarterly time
points of evaluation over 1 year of therapy.
Subjective Parameters:
The subjects were evaluated for various parameters like
Cough, Fever, Running nose, Loss of appetite, Loss of weight,
Dyspnoea, Chest Pain, Headache, Burning palm/sole, Per-
spiration, Constipation, Easy fatigability, Muscle pain, Joint
pain, Weakness, Sleeping abnormalities, Forgetfulness, Irri-
tability, Confusion, Inability to concentrate and Depression.
The parameters from this list, if present in the subjects in the
both the arms that is DCP and Placebo were considered for
analysis
Objective Parameters:
v Haematological parameters: [Haemoglobin, TLC & DLC,
ESR]
v Respiratory Performance (PFTs): [FEV-1 & FEV-1/
FVC]
v Estimation of plasma Cortisol Levels: for the stress pro-
file.
v Immunological Parameters: for the allergic profile
• IgE (Immunoglobin-E antibodies)
• C3 & C4 (Complement pathway mediators)
v Biochemical parameters:
• Random blood Sugar levels
• LFTs: S Bilirubin, S. Alkaline phosphatase, SGPT, SGOT
• S. Protein
• Lipid profile: S. Cholesterol, S. Triglycerides, HDL, LDL,
VLDL
OBSERVATIONS AND RESULTS
Summer season gave an evaluable number of 52 subjects out
of 61 enrolled. Rainy season enrolled 53 subjects eventually
given 45 evaluable cases. Similarly, winter season offered 40
subjects out of 51 and the round-the-year group covered 40
evaluable subjects out of 52 enrolled. The subjects were of
either sex (51M: 49F) in the age group of 15 years to 60. In
effect the number of cases that could be taken in for analy-
sis and observation resulted in total number of 177 subjects
who completed the study. For the data analysis, percentage
change in symptoms during summer, rainy and round the
year groups were assessed. Percentage change in symptoms
during winter season was not considered as the data was in-
consistent.
Summer season: The total numbers of symptoms in DCP
group was 35 out of which 29 are relieved after treatment of
three months. However, total symptoms in placebo group
were 54, out of which 20 relieved after treatment. The per-
centage of the symptoms relieved in DCP group was 82.8%
however; the same was 37% in placebo group. Therefore, the
percentage of relief in DCP group (CP-A) was 2.2 times more
than the placebo group (CP-B) in summer season.
Rainy season: The total numbers of symptoms in DCP
group was 135 out of which 100 relieved after treatment of 3
months. However, total symptoms in placebo group were 86
out of which 15 relieved after treatment. The percentage of
the symptoms relieved in DCP group was 74.07% however;
the same was 17.44% in placebo group. Therefore, the per-
INDIAN JOURNAL OF APPLIED RESEARCH X 209
Volume : 4 | Issue : 3 | Mar 2014 | ISSN - 2249-555X
RESEARCH PAPER
centage of relief in DCP group (CP-A) was 4.2 times more
than the placebo group (CP-B) in rainy season.
Combined effect of study drugs on symptoms in summer
and rainy seasons:
When the symptoms of both summer and rainy season are
assessed together, the total numbers of symptoms in suffer-
ers in DCP group was 170 out of which 129 relieved after
treatment. However, total symptoms in sufferers in placebo-
group were 140 out of which 35 relieved after treatment.
The percentage of the symptoms relieved in DCP group was
75.88 however; the same was 25% in placebo group. There-
fore, the percentage of relief in DCP group was found to be
3 times more than the placebo group (Table 8).
Table 8: Showing the effect of study drugs on symptoms
on seasonal influences
Symptom Effect (DCP) Effect (Placebo)
Before Rx
After Rx
Before Rx
After Rx
Cough
27
24
19
8
Dyspnoea
27
23
21
7
Running nose
19
14
15
2
Feeling of run-
down
23 19 24 7
Weakness
19
14
14
2
Loss of ap-
petite
21 20 22 5
Fatigue
11
4
6
0
Muscle pain
5
3
5
1
Joint pain
5
2
3
0
Perspiration
13
6
11
3
Total
170
129
140
35
% Relief
75.88
25
Effect of DCP therapy on Haematological Parameters:
On Leucocytes: Following one year of treatment with the
trial drug: DCP or the Placebo, no significant changes were
observed in the Total Leucocytes Count as well as in the
Differential Leucocytes Count (except Eosinophils) in both
(CP-A & CP-B) groups. The same observation was made in
any particular season. The variations were minimal and non-
significant.
On Eosinophils: Observation during the summer season
showed a decrease in the Eosinophil count after 3 months
treatment with DCP (CP-A group), the percentage reduction
being 25% (approx) was statistically significant. Eosinophil
count decreased to some extent in the CP-B group which
is statistically non-significant. Similarly, in the winter season,
there was a clinically significant reduction (10.26%) seen in
the eosinophil count in group CP-A subjects. On the contrary,
there was a marginal rise in CP-B group. However, they were
found to be within normal group limits in both the groups.
Rainy season did not bring about any change in the eosino-
phil count.
On Haemoglobin: Neither DCP nor placebo could make any
impact on increase nor decrease of Haemoglobin levels in
any of the study groups.
On ESR: CP-A group showed statistically and clinically sig-
nificant reduction in ESR after treatment. The reduction is
consistent in all the seasons. Therapy during the summer
season brought about a reduction in the ESR by 38.7% and
the rainy season result showed 12.7% decrease. Even in the
winter season, 26.14% reduction was seen in the ESR and the
round-the-year group had a 39%. Such a trend showed DCP
to have a beneficial effect on lowering the ESR hence indicat-
ing a decreased disease activity in the body as ESR is a mark-
er of inflammation, infection or any allergic manifestations.
CP-B group rather showed an increase in the ESR value.
Effect of DCP therapy on Pulmonary Function (PFTs): The
pulmonary function tests assessed in the study were FEV-1
(the Forced Expiratory Volume in 1 second) and FEV-1/FVC
(Forced Vital capacity). The percentage increase in the CP-A
group for both the parameters was clinically significant in the
summer season. An increase was seen in the FEV-1 by 11.8%
as opposed to none in the CP-B and the ratio of FEV-1 and
FVC rose by 4.08% The winter too saw an increase in the
FEV-1 by 11.83% in the CPA group, as opposed to a minor
decrease in the CP-B group. Round the year as well, in the
CP-A group, a gradual increase in the mean value of both
the parameters was seen throughout the study period at all
time points, where as the changes in the CP-B group hardly
showed any change.
Effect of DCP therapy on plasma cortisol levels: Plasma
cortisol levels were measured at the decided time points to
check upon the influence of DCP on decreasing the stress
levels since plasma cortisol is a marker of stress.
In summer, DCP treated group showed a decreased mean
plasma cortisol level after 3 months of treatment duration.
A marked decrease by 22.15% was observed as opposed to
a mere 0.10% decrease in the CP-B group. Even in rains,
the trend was the same in DCP treated group a decrease by
12.9%was observed, whereas, the placebo showed a 5.5%
increase. The winter data showed a decreased mean plasma
cortisol level by 22.12% after 3 months of DCP treatment, the
placebo showed a 13.1% increase.
Round the year the DCP treated group showed a decreasing
trend in the mean plasma cortisol level throughout the treat-
ment duration, and by the end of the therapy, a decrease by
25% was observed which is highly significant, both clinically
and statistically (p < 0.01). In the placebo treated group, the
changes were negligible. Therefore, it may be concluded
that DCP has an advantage in comparison to the placebo,
in decreasing the cortisol levels (a marker of stress), thereby
indicating that it is capable of fighting stress irrespective of
the season.
Effect of DCP therapy on immunological parameters: The
immunological parameters assessed in the study were IgE
antibodies; C3 and C4 complement activation agents.
CP-A group brought about a decrease in the levels of IgE
after treatment, bringing down the baseline value by nearly
30% (+ve). On the other hand, the placebo showed increase
in IgE levels after treatment, percentage increase being
18.3% (--ve) in the rains, DCP brought about a significant
decrease in the levels of IgE antibodies by 15% (+ve). CP-B
group showed a decrease as well but it was insignificant
(+ve).
Regarding the C3 and C4 mediators, the changes before and
after the treatment in either group in any particular season
were not significant.
From the above results, it may be concluded that, CP-A
(DCP) treatment helps in reducing the circulating lgE anti-
bodies, thereby showing immunomodulatory activity of DCP
and make individuals less prone to frequent infections, aller-
gies etc.
Effect of DCP therapy on Biochemical parameters: The
LFT and RFT test findings have no significant change at the
end of the study in any of the groups when compared with
baseline.
Serum proteins remained unaffected and Random Blood
Sugar levels showed insignificant changes, which however
remained within the normal group clinical range. None of the
parameters showed any significant change in the lipid profile
during/after the treatment with DCP, The bio-chemical values
showed minor changes which was neither clinically nor statis-
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RESEARCH PAPER
tically significant. CP-B group share a similar pattern in the
lipid profile changes.
Hence it is evident that DCP intake during any season
throughout the year does not after any liver enzymatic activ-
ity function, nor does it hamper the renal system in any pos-
sible manner. Blood sugar levels remain in safe limits as well,
and the lipid profile does not undergo any bad influence.
These points hence prove the safety aspect and the possible
wide compliance of DCP.
DISCUSSION
The results of both the clinical studies are suggestive of the
fact that there was significant reduction in the symptoms as
well as biochemical parameters like IgE, C3, C4, IgG, Corti-
sol and ESR. The immunologic variations in different seasons
throughout the year and causes of allergic rhinitis underscore
the important roles of both adaptive and innate immune sys-
tems. In recent years, appreciation of the role of nasal innate
immunity has grown and evidence suggests that the patho-
genesis of allergic rhinitis is partially mediated by the innate
immune system. The interplay between the external environ-
ment and nasal mucosa contributes to innate-immune-medi-
ated development of allergic rhinitis13.
1) Percentage of Symptom relief after administering DCP
When the symptoms of both summer and rainy season are
assessed together, the total numbers of symptoms in suffer-
ers in DCP group was 170 out of which 129 relieved after
treatment. However, total symptoms in sufferers in placebo
group were 140 out of which 35 relieved after treatment.
The percentage of the symptoms relieved in DCP group
was 75.88 % however; the same was 25% in placebo group.
Therefore, the percentage of relief in DCP group (CP-A) was
found to be 3 times more than the placebo group (CP-B).
2.) Effect on IgE
In the first study, IgE levels in the serum came down even
in the normal group, it could be summarised that the blood
relatives of the allergic patients or normal groups exposed
to lung irritants/pollutants either because of general air pol-
lution or being in polluting occupations, would become less
susceptible to recurrent cough and cold.
It was found that IgE values were the maximum in the Allergic
group at the baseline and minimum in the viral group. In all
the groups, a definite decrease was noticed after taking DCP.
It was observed that the decline in IgE was more in children
and young adults than in the elderly. It was clearly seen that
administration of DCP was helpful in decreasing the elevated
level of IgE in the allergic group. Decrease in IgE lessens the
tendency to develop an allergic reaction. Consuming DCP
thus should be helpful in reducing susceptibility to allergies.
In the second study, during Summer Season (n=52) - DCP
brought about a significant decrease in the levels of IgE anti-
bodies by 15%. CP-B group showed a decrease as well but
it was insignificant (5%) During Rainy Season (n=53) - CP-A
group showed a decrease in the IgE levels after treatment,
bringing down the baseline value by nearly 30%. On the
other hand, the placebo showed an increase in IgE levels
after treatment, percentage increase being 18.3%.During
winter Season (n=40) - CP-A showed a significant decrease
in the levels of IgE antibodies after DCP treatment, bringing
down the baseline value by 11.6% while CP-B group showed
a decrease of 4%.
Round-the-year (n=40) - DCP therapy showed a reduction in
IgE levels right from the baseline and eventually by the end
of 1 year of therapy, at the 3rd time point, a reduction by 23%
of the baseline was observed where as the placebo showed
7% reduction in IgE levels when compared to the baseline.
On observing the decrease in IgE levels in the two studies re-
viewed, it may be concluded that administration of DCP has
definite effect on improving immunity status during different
times of a year (seasonal variation) and this improvement in
IgE levels was found to be more than 3 times compared to
those who are on placebo
3) EFFECT ON C3 C4 CELLS
C3 and C4 levels showed a lot of scatter, but discernible
trend in the patients was towards lowering of their values in
the serum. A decrease in C3 level in the serum was noted
in all the groups. A decrease in C4 was noted in all groups
of patients but not in the Normal groups. In the Bacterial
group, 9 out of 10 showed decreased C3, and 8 out of 10
showed decreased C4. As we know, the complement sys-
tem is a cascading series of plasma enzymes and proteins
capable of cell lyses. Activation of the classic complement
pathway via C1, C4 and C2 and activation of the alternative
complement pathway via D, C3 and factor B, ultimately leads
to cell lyses. C3 and C4 levels thus indicate the functioning
of the two arms of the complement pathway. The pivotal
compound in this pathway is C3, which splits to form C3b
and is necessary for activation of components C5-C9, which
cause lyses of the cells. A decrease in C3 and C4 following
administration of CP would indicate a lesser activation of the
complement pathway. This would indicate less cellular de-
struction and an overall healthy individual. A lot of scatter in
the results calls for a larger study in this area.
4) Effect on IgG levels:
Effect of DCP on IgG levels was observed in only first study
(nasal allergies and viral infections).
One of the frequent clinical problems in any type of IgG de-
ficiency are recurrent or chronic infections of the upper and
lower respiratory tracts.
IgG decreased in all groups except the Viral. This was quite
appreciable in the Bacterial group. IgG in the predominant
antibody in the serum and it carries the major burden of neu-
tralizing the bacterial toxins and binding to microorganisms
to enhance their phagocytosis. Significantly lower levels of
IgG antibody in the Bacterial group after taking CP could
be because of lesser bacterial stimulus to the production of
IgG antibody. Intake of CP probably reduced the number
of bacteria which could stimulate IgG production and hence
resulted in lower IgG levels. This contention could be fur-
ther substantiated by subsequent studies on bacterial colony
count in sputum cultures after taking DCP. IgG is well distrib-
uted in intravascular and extra vascular spaces and is impor-
tant in the secondary antibody responses (immune memory).
It plays an important role in host defence against infection.
IgG protects tissues from bacteria, viruses, and toxins. Dif-
ferent subclasses of IgG neutralize bacterial toxins, activate
complement, and enhance phagocytosis by opsonisation14.
4) Effect on ESR counts
A decrease was observed in ESR levels in the study on nasal
allergies and viral infections in all the groups of patients indi-
cating lessened inflammatory activity in the body, be it in the
lungs, nose, throat or anywhere else in the body. There were
70% of subjects who have shown significant reduction in ESR.
In the study on seasonal influences, CP-A group showed
statistically and clinically significant reduction in ESR after
treatment. The reduction is consistent in all the seasons. DCP
therapy during the summer season showed 38.7% reduction
in ESR levels while the same during rainy season was 12.7%
decrease. During winter season, 26.14% reduction was seen
in the ESR and the round-the-year group showed 39% re-
duction. This trend of reduction seen with the subjects on
ESR lowering in DCP group indicates a decreased disease
activity (immunity enhancing activity) in the body as ESR is a
marker of inflammation, infection or any allergic manifesta-
tions. CP-B group which was on placebo on the other hand
showed an increase in the ESR value. These findings suggest
that there was a considerable improvement in ESR in DCP
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RESEARCH PAPER
group in comparison to placebo.
5) Effect on serum proteins:
Serum protein values and its various fractions or ratios before
and after giving DCP did not indicate any particular trend in
the immune status
6) Quality of Life Index (QLI): QLI took into consideration
five types of problems, namely 1) Physical, 2) Cognitive, 3)
Affective, 4) Social and 5) Ego. Each type had five entities,
scales from 1 to 5 and the number achieved was multiplied
by 4, to make up to a maximum of 100.
The QLI increased in all the groups. Maximum increase was
observed in the Allergic group. Maximum benefit perceived
was in Physical problems. Benefit in Affective (mood) prob-
lems was also there. No significant change was observed in
Social Dysfunction and Ego problems.
CONCLUSION:
After reviewing critically the data from both the studies it can
be concluded that
1. Dabur Chyawanprash (DCP) boosts immunity
2. DCP reduces the disease symptoms of seasonal influ-
ences.
3. DCP modulates IgE levels positively.
4. DCP modulates immunity markers C3 and C4 levels.
5. DCP improves pulmonary functions.
6. DCP decreases cortisol levels.
7. DCP does not alter LFT and RFT parameters
8. DCP increases Quality of Life.
Results are suggestive that regular usage of DCP in the rec-
ommended doasge is safe and effective in providing immu-
nity and improves quality of life. It provides considerable (2.2
to 4.2 times) benefit on reduction of disease symptoms in
different seasons. Finally, the reduction in the IgE levels (1/3rd
decrease) is indicative of decreased possibility of occurrence
of allergic symptoms including recurrent cough and cold af-
ter taking DCP. In light of overall positive results in immunity
related clinical as well as laboratory parameters in the clini-
cal studies, it can be concluded that DCP provides around
three times immunity upon regular use in the recommended
dosage. Earlier published pre clinical studies on safety and
immunity markers were also showing that DCP is safe and
provides more than three times immunity.
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