Original ARticle

Bresol Tablets in the Management of Nasal Allergy

and Allergic Rhinitis: An Open, Prospective Trial
S Chandrasekharan*, Dr. Rangesh Paramesh, M.D (Ay)

Abstract
Allergic rhinitis is a specific allergic reaction of the nasal mucosa and is characterized by rhinorrhea, sneezing, nasal congestion
and pruritus of the eyes, nose and throat. The purpose of this study was to evaluate the safety and efficacy of Bresol tablets
in the management of allergic rhinitis. The present study was an open, prospective, noncomparative clinical trial conducted
in 50 patients suffering from allergic rhinitis. At the initial visit, the patients were subjected to a detailed medical history
followed by a thorough clinical examination. The patients were administered Bresol tablets at a dosage of two tablets, twice
a day orally for a period of four weeks. All the patients were followed-up at weekly intervals for a period of four weeks, and
were evaluated for clinical relief from individual symptoms of allergic rhinitis, which included sneezing, nasal congestion,
itching of the eyes and nose, postnasal drip, rhinorrhea and watery eyes using 10-point visual analog scale. They were also
investigated for hematological parameters. Treatment with Bresol tablets showed significant improvements in all the symptoms
of allergic rhinitis by the second week; further improvement was observed with the treatment by the fourth week. All subjects
completed the study. Significant improvement was also observed in hematological parameters such as absolute eosinophil
count and other supporting parameters such as erythrocyte sedimentation rate (ESR), total leukocyte count and differential
count. No adverse effects were reported or observed during the study and compliance to the use of formulation was good.
The findings reported in this study shows that Bresol tablets of The Himalaya Drug Company help in relieving the symptoms
of allergic rhinitis and also normalize absolute eosinophilic count, ESR, total leukocyte count and differential count. None
of the volunteers experienced any hypersensitivity reactions. Therefore, it can be concluded that the test medication Bresol
tablet is safe and effective in the management of allergic rhinitis.
Key words: Allergic rhinitis, Bresol tablet

llergic rhinitis, often considered a trivial disease,

is now increasingly being recognized as a cause
of significant and widespread morbidity.1 It
is the most common allergic disorder, affecting 10%
to 20% of the population.2,3 Earlier, allergic rhinitis
was classified into seasonal, perennial or occupational
depending upon the period of exposure to allergens.4
However, this classification had certain limitations such
as both seasonal and perennial allergens are sensitized
and seasonal allergens may also cause perennial allergic
symptoms.5,6
Allergic rhinitis is characterized by continuous or
periodic nasal congestion; rhinorrhea; sneezing; pruritus
of the conjunctiva, nasal mucosa and oropharynx;
allergic shiners; lacrimation and fatigue. Predisposing
factors of allergic rhinitis include family history of
similar symptoms and personal history of collateral
*Chest Specialist, Public Health Centre, Chennai
Address for correspondence
Dr S Chandrasekharan
Chest Specialist, Public Health Centre
4, Jambulingam Street, Off. Valluvarkottam High Road
Nungambakkam, Chennai - 600 034

Indian Journal of Clinical Practice, Vol. 21, No. 1, June 2010

allergy manifested as eczematous dermatitis, urticaria

and/or asthma. Clinical presentation may include
nasal polyps, pale and boggy (sometimes reddened or
excoriated) nasal passages, congested and edematous
conjunctiva, injected pharynx and swelling of the
turbinates and membranes of the ear.
Often, there is a temporal relationship between an
allergen exposure and an acute episode of allergic
rhinitis. Environmental agents that can cause this
condition are dust mites, feathers, animal dander,
moulds, pollen, grass and fungal spores. Patients with
allergic rhinitis are often allergic to certain foods such
as eggs, nuts, fish, shellfish, dairy products or wheat
and may experience symptoms of the disease as a result
of allergy-triggering substances present in these food
items.7
Uncontrolled symptoms of allergic rhinitis may result
in sleep loss, secondary daytime fatigue, learning
impairment, decreased overall cognitive functioning,
decreased long-term productivity and decreased qualityof-life. Additionally, uncontrolled allergic rhinitis may
also cause other diseases such as acute and chronic
13

Original ARticle
sinusitis, recurrence of nasal polyps, otitis media/otitis
media with effusion, hearing impairment, abnormal
craniofacial development, sleep apnea and related
complications, aggravation of underlying asthma and
increased propensity to develop asthma.8
The three basic approaches for the treatment of
allergies are avoidance, pharmacotherapy and immunotherapy. Treatment should start with avoidance
to allergens. In almost all cases, however, some
pharmacotherapy is needed. The available treatment
options for upper and lower respiratory tract allergic
diseases have major limitations due to low efficacy,
associated adverse events and compliance issues.
Antihistamines, sympathomimetics, xanthine derivatives
are commonly used as the first-line treatment for
symptomatic management, but they do not prevent
recurrent episodes.9 Use of glucocorticosteroids and
anticholinergics is questionable due to long-term adverse
effects. Prophylactic use of mast cell stabilizers has the
disadvantage of frequent administration. Decongestant
drugs are effective in the treatment of nasal obstruction;
however, they do not improve other symptoms of rhinitis
and have high incidence of adverse effects. Studies with
the leukotriene receptor antagonists as a sole therapy in
these allergic diseases have proved disappointing.10,11
Several phytotherapeutic herbs with potent antiallergic, antioxidant, immunomodulatory, antitussive
and mucolytic activities have been found to be effective
in the management of allergic rhinitis. Bresol tablet an Ayurvedic formulation containing the extracts of
Curcuma longa, Ocimum sanctum, Adhatoda vasica,
Trikatu, Triphala, Embelia ribes, Cyperus rotundus,
Cinnamomum zeylanicum, Elettaria cardamomum,
Cinnamomum tamala and Mesua ferrea - is claimed to
be effective in the treatment of allergic rhinitis. The
present study was conducted to evaluate the safety and
efficacy of Bresol tablet in the management of allergic
rhinitis.
Material and Methods
The study was an open, prospective, noncomparative
clinical trial conducted at Public Health Centre,
Chennai, India. Fifty patients (17 males and 33
females) in the age group of 18-50 years (mean age:
40.70 17.06 years) who presented with symptoms
of allergic rhinitis (sneezing, nasal congestion, itching of
the nose, postnasal drip and rhinorrhea) were included
in the study after signing the informed consent form
(Table 1). Patients with obstruction-causing nasal
14

Table 1. Demographic Data on Entry

Parameters

Bresol tablet
(n = 50)

Male : Female

17 : 33

Age in years
(mean SD)
No. of patients
presenting the
symptoms

40.70 17.06
Nasal allergy

Allergic rhinitis

18

Upper respiratory tract

infection

14

Bronchitis, influenza,
common cold

14

abnormalities, acute respiratory infection or severe

concomitant disease were excluded from the study.
Additionally excluded from the study were women
with the likelihood of pregnancy as well as pregnant
and lactating women. All subjects completed the study
without any dropouts.
Patients who met the eligibility criteria were enrolled
and their informed consents were obtained. At the
initial visit, a detailed medical history was obtained
from all patients. A thorough systemic examination
was done in all the patients followed by a detailed
ENT examination. After initial examination, each
patient was administered Bresol tablets at a dosage of
two tablets, twice-daily for a period of four weeks.
Primary and Secondary End Points

The predefined primary end points were duration

required for effective relief from symptoms such as
sneezing, nasal congestion, itching of the eyes and
nose, postnasal drip, rhinorrhea and watery eyes. The
predefined secondary safety end points were short- and
long-term safety, as assessed by the incidence of adverse
events and patient compliance to therapy and blood
parameters such as absolute eosinophil count (AEC),
erythrocyte sedimentation rate (ESR), total leukocyte
count and differential count.
Follow-up and Assessment

All the patients were followed-up at weekly intervals

for a period of four weeks, and the symptom score
evaluation was done during each follow-up visit.
A 10point visual analog scale was used to evaluate the
relief from symptoms of allergic rhinitis at all visits.
Indian Journal of Clinical Practice, Vol. 21, No. 1, June 2010

Original ARticle
All the adverse events, either reported or observed by
the patients, were recorded with information about
severity, date of onset, duration and action taken
regarding the study drug. Relation of adverse events
to study medication was predefined as Unrelated
(a reaction that does not follow a reasonable temporal
sequence from the administration of the drug), Possible
(follows a known response pattern to the suspected
drug, but could have been produced by the patients
clinical state or other modes of therapy administered
to the patient) and Probable (follows a known
response pattern to the suspected drug that could not
be reasonably explained by the known characteristics
of the patients clinical state). Patients were allowed to
voluntarily withdraw from the study, if they experienced
serious discomfort during the study or sustained serious
clinical events requiring specific treatment.
Statistical Analysis

Statistical analysis was done using GraphPad Prism

Software, Version 4.03, for Windows (GraphPad

Software, San Diego, California, USA) by repeated

measures of ANOVA (Friedmans test) followed by
Dunnetts multiple comparison post-hoc test for the
analysis of clinical symptom score; incidence of relief
from symptoms in patients were assessed using Fisher
exact test. Analysis of hematological parameters was
carried out using paired Student t test. The minimum
level of significance was fixed at p < 0.05.
Results
Results of the study showed significant improvements
in symptoms such as sneezing, nasal congestion,
itching of eyes and nose, postnasal drip, rhinorrhea,
watery eyes in patients treated with Bresol tablets. The
baseline sneezing score of 7.57 2.73 was reduced to
0.74 1.68 (with a significance of p < 0.01) at the
end of four weeks of treatment (Table 2). Of the 42
patients who presented with sneezing at the beginning
of the study, only eight patients had persistent sneezing
at the end of the treatment - protection of 80.95% and
significance of p < 0.0001 (Table 3).

Table 2. Clinical Relief from Symptoms of Allergic Rhinitis

Symptoms

Week 0

Week 1

Week 2

Week 3

Week 4

Sneezing (n = 42)

7.57 2.73

5.67 2.63
a
p < 0.05

2.41 2.83
a
p < 0.001
b
p < 0.01

1.05 2.31
a
p < 0.001
b
p < 0.001

0.74 1.68
a
p < 0.001
b
p < 0.001

Nasal congestion (n = 40)

7.75 1.91

5.88 2.15

2.05 2.57
a
p < 0.001
b
p < 0.001

1.15 2.12
a
p < 0.001
b
p < 0.001

0.78 1.63
a
p < 0.001
b
p < 0.001

Itching of eyes (n = 23)

6.09 2.45

4.00 2.89
a
p < 0.05

2.00 2.71
a
p < 0.001

1.74 2.73
a
p < 0.001
b
p < 0.05

1.09 1.91
a
p < 0.001
b
p < 0.01

Itching of nose (n = 20)

6.75 2.20

4.55 2.44

2.85 2.76
a
p < 0.001

1.35 1.98
a
p < 0.001
b
p < 0.01

1.20 1.82
a
p < 0.001
b
p < 0.001

Postnasal drip (n = 20)

6.05 1.82

4.35 2.16

2.50 2.37
a
p < 0.001

1.65 2.23
a
p < 0.001
b
p < 0.01

1.35 1.69
a
p < 0.001
b
p < 0.001

Rhinorrhea (n = 23)

7.22 1.95

5.44 2.23

3.17 2.23
a
p < 0.001

1.26 1.79
a
p < 0.001
b
p < 0.001

0.87 1.42
a
p < 0.001
b
p < 0.001
c
p < 0.05

Watery eyes (n = 13)

6.39 2.22

4.92 2.36

3.46 2.82
a
p < 0.05

1.77 1.83
a
p < 0.001
b
p < 0.01

1.15 1.41
a
p < 0.001
b
p < 0.001

Statistical analysis was done by repeated measures of ANOVA using Friedman test followed by Dunnetts multiple comparison post-hoc test.
a
As compared to baseline values; bAs compared to week 1 values; cAs compared to week 2 values.

Indian Journal of Clinical Practice, Vol. 21, No. 1, June 2010

15

Original ARticle
Table 3. Number of Patients Showing Complete Relief
from Symptoms of Allergic Rhinitis at the End of the Study

Table 4. Effect of Bresol Tablets on Total Leukocyte

Count, Differential Leukocyte Count, ESR and AEC

Symptoms

Parameters

No. of patients
Initial
Final

Significance

Protection (%)

End of the study

(after treatment)

Significance

11,030 2,836

9,864 2,180

p < 0.001

Sneezing

42

p < 0.0001

80.95

Nasal congestion

40

10

p < 0.0001

75

Itching of the eyes

23

p < 0.0001

69.57

Neutrophils (%)

65.65 9.24

64.53 7.23

NS

Itching of the nose

20

p < 0.0001

65

Lymphocytes (%)

30.40 10.39

32.62 8.50

p < 0.007

Postnasal drip

20

p < 0.0001

55

Eosinophils (%)

4.62 4.34

3.76 4.29

p < 0.015

Rhinorrhea

23

p < 0.0001

69.57

Monocytes (%)

0.40 1.09

0.35 1.03

NS

Watery eyes

13

p < 0.005

53.85

ESR (mm/h)

19.27 9.77

15.20 5.79

p < 0.0001

Absolute
eosinophil count

423.6 255.8

310 185.9

p < 0.0004

Statistical analysis was done by Fishers exact test.

Nasal congestion score improved from 7.75 1.91

(at baseline) to 0.78 1.63 (at the end of 4 weeks)
with a significance of p < 0.001 (Table 2). Of the 40
patients who presented with nasal congestion at entry,
only 10 patients presented with the symptoms at the
end of the treatment - 75% protection and significance
of p < 0.0001 (Table 3).
The score for itching of eyes of 6.09 2.45 at baseline
was reduced to 1.09 1.91 at the end of the treatment
with a significance of p < 0.001 (Table 2). Similarly,
the scores for itching of the nose and postnasal
drip of 6.75 2.20 and 6.05 1.82 at baseline
reduced to 1.201.82 and 1.35 1.69, respectively at
the end of four weeks of treatment with a significance
of p<0.001. Score for rhinorrhea reduced from
7.221.95 (at baseline) to 0.87 1.42 (at the end
of 4 weeks) with a significance of p < 0.001 and for
watery eyes it reduced from 6.39 2.22 (at baseline)
to 1.15 1.41 (at the end of the treatment; Table 2).
There was also a significant improvement in
hematological parameters such as total leukocyte
count, lymphocytes, eosinophils, ESR and AEC.
Total leukocyte count (cells/mm3) decreased from
11,030 2,836 (at baseline) to 9,864 2,180 (at the
end of 4 weeks). AEC decreased from 423.6 255.8
(at baseline) to 310 185.9 (at the end of 4 weeks)
with a significance of p < 0.0004. ESR values decreased
from 19.27 9.77 (at baseline) to 15.20 5.79 with a
significance of p < 0.0001 (Table 4). No adverse effects
were reported during the study and drug compliance
was excellent.
16

Baseline
(before
treatment)

Total leukocyte
count (cells/mm3)

Statistical analysis is done by Students paired t test.

Discussion
Allergic rhinitis is characterized by a two-phase
allergic reaction - the initial sensitization phase (IgE
formation and triggering of the humoral response) and
the clinical disease phase (manifesting symptoms). The
clinical disease phase can be further subdivided into
two distinct phases, namely early (mediated through
mast cells) and late (cellular infiltration and mediator
release).12 In the early phase, mast cells release mediators
as a result of antigen cross-linking of IgE molecules,
which results in an explosive degranulation of mast
cells, leading to the characteristic symptoms of rhinitis
(rhinorrhea, nasal obstruction and itching, sneezing,
postnasal drip and loss of sense of smell).11
Control of cytokine release from airway epithelial cells
is a primary approach in the management of allergic
rhinitis, and topical corticosteroids with oral antihistamines are the mainstay in the management of allergic
rhinitis. In treatment-resistant patients, the effects of
allergen-specific immunotherapy can be beneficial.13
The present study showed excellent symptomatic
control as evident by significant reduction in the mean
scores for sneezing, nasal congestion, itching of the eyes
and nose, postnasal drip, rhinorrhea and watery eyes
at the end of the study. A significant improvement in
the values of hematological parameters (total leukocyte
count, eosinophil count and AEC count) at the end
of the treatment compared to their baseline values was
observed. There was also a significant reduction in
lymphocyte count and ESR at the end of the study.
Indian Journal of Clinical Practice, Vol. 21, No. 1, June 2010

Original ARticle
Curcumin from C. longa is reported to have
antiallergic property, as tested in an in vitro model of
airway hyperresponsiveness.14 In different animal and
human studies, curcumin-I, -II and -III (components
of C. longa) have been shown to inhibit a number of
molecules involved in inflammation [phospholipase,
lipooxygenase, cyclooxygenase (COX)-1 and -2,
leukotrienes, thromboxane (TX), prostaglandins
(PG), nitric oxide, collagenase, elastase, hyaluronidase,
monocyte chemoattractant protein-1, interferoninducible protein, tumor necrosis factor and interleukin12].15-17
Curcumin is also shown to have immunostimulatory
activity, which increases circulating antibody titer,
plaque forming cells, alpha-esterase positive cells and
phagocytosis.18
The active principles of Zingiber officinale (one of
the constituents of Trikatu) are potent inhibitors of
prostaglandin biosynthesizing enzyme (PG synthetase)
and the structures of these compounds indicate that
the inhibitors would also be active against arachidonate
5lipoxygenase (an enzyme of leukotriene biosynthesis).
Z. officinale inhibits biotransformation of arachidonic
acid comparable to indomethacin.19 Other principles of
Z. officinale, oleoresins ([8]-paradol and [8]-shogaol),
have inhibitory effects on COX-2 enzymes20 and the
mechanism of action is hypothesized by the attenuation
of COX-1/TX synthase enzymatic activity.21
Piper longum (another constituent of Trikatu) is a potent
inhibitor of COX-1 and -2, which are the mediators
of inflammation.22 P. longum is also reported to
retard macrophage recruitment and suppress cytokine
production.23
Emblica officinalis (an important constituent of
Triphala) is reported to possess antiphlogistic,
antispasmolytic and antioxidant activities besides
reducing mucus secretion in the airways.24
Terminalia belerica (another constituent of Triphala)
has potent antifungal activity.25 The herb is also
reported to possess potent antioxidant activity.26
C. rotundus inhibits NO and O2 production in vitro
and the inhibition is due to the suppression of iNOS
protein, as well as iNOS mRNA expression.27
O. sanctum is known to stimulate humoral immunologic response (an increase in antibody titer) and
cellular immunologic response (E-rosette formation
Indian Journal of Clinical Practice, Vol. 21, No. 1, June 2010

and lymphocytosis),28 decrease histamine release from

mast cells (humoral immune responses) and inhibit
leukocyte migration (cell-mediated immune responses).
This immunomodulatory effect is postulated to be
mediated by GABAergic pathways.29 O. sanctum is
also showed potent anti-inflammatory (COX-1 & -2
inhibitory) activity.30
Widely used as mucolytics, benzylamines (bromhexine
and ambroxol) are the semi-synthetic derivatives of
vasicine extracted from A. vasica. These benzylamines
enhance lysozyme levels in respiratory tract secretions
and clear bacilli-laden mucus.31 A. vasica is reported
to have potent anti-inflammatory activity equivalent
to that of hydrocortisone.32 The antitussive activity of
A. vasica was investigated and found to be similar to
codeine, in vitro.33
The herbs present in Bresol tablets is reported to
possess anti-inflammatory, antiallergic, antioxidant,
immunomodulatory and antitussive activities and also
stabilize mast cell and reduce mucus secretion. The
efficacy of Bresol tablets in relieving the symptoms
of allergic rhinitis could be attributed to the
synergistic effects of all the ingredients present in the
formulation.
Conclusion
Results of the study show that Bresol tablet of The
Himalaya Drug Company is effective in relieving the
symptoms of allergic rhinitis as well as in normalizing
the values of AEC and ESR. None of the volunteers
experienced any adverse effects. Therefore, it may be
concluded that Bresol tablet is safe and effective in the
management of allergic rhinitis.
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