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Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya

Journal of Pharmaceutical and Scientific Innovation


www.jpsionline.com
Research Article
COMPARATIVE THERAPEUTIC EFFECTS OF VARIOUS MORPHOLOGICAL FORMS OF NASYA (NASAL
ROUTE OF DRUG DELIVERY) IN PRATISHYAYA (RHINOSINUSITIS) WITH REFERENCE TO NASAL
MUCO-CILIARY FUNCTION
Bhardwaj Atul*
Assistant Professor, Department of Shalakya Tantra, M.S.M. Institute of Ayurveda, B.P.S. Mahila Vishwavidyalaya, Khanpur
Kalan, Sonipat-131305, Haryana, India.
*Email: dratulbhardwaj@gmail.com
Received on: 15/08/12 Revised on: 23/09/12 Accepted on: 05/10/12
ABSTRACT
Different morphological forms of Nasyas (Nasal route of drug administration in Ayurveda) like Taila and Ghrita (lipid based nasal drops), churna (dry fine
powder) and Avpeeda nasya (Aqueous based medicated decoction nasal drops) are commonly used as nasal drugs for the management of rhinological
disorders in Ayurveda and they distinctly behave differently in the nasal cavity when introduced. This present study explores how these different
morphological forms of Nasyas effects the nasal health and mucociliary mechanism in the patients of Pratishyaya i.e. Rhinosinusitis with the help of
Goldmans saccharin test which is carried out at various stages of this study. Clinically, endoscopically and radiologically diagnosed patients of Pratishyaya
i.e. rhinosinusitis, satisfying the inclusion criteria were divided randomly by table method into four groups. A total of 40 patients were subjected in this trial
after ramification into four trial groups with 10 patients in each group. Anu taila nasya, Shadbindu ghrita nasya, Katphala churna nasya and Pippali Avapeeda
nasya respectively were selected for the present study in trial groups I IV as they are the most frequently prescribed drugs in Ayurveda (Indian system of
medicine) for the management of the disease Pratishyaya i.e. Rhinosinusitis. These selected drugs subtly represent medicated oils/lipids, powder insufflations
(errhines) and medicated aqueous base decoction form of nasal drug administration when visualized in morphological appearance and modern perspective.
Goldmans saccharin test, which is used for the present study is a gold standard test for the evaluation of nasal mucociliary function and is directly related to
nasal health. Powder form of nasal administered drug i.e. Katphala Churna nasya (powder form) was found to be most effective in improvement of
endoscopic and radiological parameters of rhinosinusitis. Mucoadhesive properties of Anu Taila nasya and Shadbindu ghrita nasya (both lipid base Nasya)
probably increases the physical weight on the mucosa thus deceases the ciliary transport transiently. Pippalyadi Avpeeda nasya (aqueous base nasal drops) was
found to be most effective in enhancing mucociliary clearance activity.
Key words: Ayurveda (Indian system of medicine), Nasya (Nasal route of drug administration in Ayurveda), Pratishyaya (Rhinosinusitis), Saccharin test,
Mucociliary clearance mechanism (MCCM).

INTRODUCTION
While going through the Ayurvedic literature a vivid
description of the disease Pratishyaya is observed. There is
descriptive mention of this disease with regard to
aetiopathogenesis,
classification,
symptomatology,
complications and management as ancient Ayurveda science
was well versed with the concept of Pratishyaya. The disease
is the most elaborated disorder among all Nasa Rogas
(rhinological disorders) but the description seems to be
scattered at various places. The disease has got localized as
well as somatic effects and accepted as a potential cause of
Kshya roga (emaciation) 1 and thus, the management of
Pratishyaya should never be neglected or delayed in this
respect. Different types type of Pratishyaya when gets
complicated with added difficulties in treatment then a
common
term
Dusta
Pratishyaya
(complicated
rhinosinusitis) is used.2 After evaluating the aetiological
factors, symptomatology and complications of the disease
Pratishyaya it seems quite prudent to accept that these
features has got close proximity and compatibility with most
common rhinological disorder termed as Rhinosinusitis.
Rhinosinusitis affects millions of the population throughout
the globe. Despite the enormity of the problem the
pathophysiology of the disease still eludes the scientific
community. Unfortunately the nose, with its convoluted
architecture, is prone to obstructive diseases. Although the
mucociliary pathways work harmoniously in health, infection
can rapidly throw this delicate mechanism into disarray. 3
Most infection of the paranasal sinuses arise from primary
focus in the nose and ciliary dysfunction being the most
important factor responsible for the genesis of rhinosinusitis.

Anderson in 1974 introduces the use of Saccharin in


estimating time interval between putting this saccharin in the
nasal mucosa and perception of sweet taste as a diagnostic
tool for the measurement of nasal mucociliary function. This
Saccharin test then becomes a gold standard diagnostic
tool for the evaluation of ciliary function worldwide. 4
Three factors, however appears crucial for the normal
physiological functioning of the nose and paranasal sinuses:
normal mucociliary transport, patency of osteomeatal unit
and normal quality and quantity of secretions. Disruption of
any one or more factors can predispose rhinosinusitis.
Mucociliary clearance mechanism (MCCM) is the most
important of all of these factors and is the most important
guiding factor in genesis of rhinosinusitis and is conformed
by various histocytological, beat frequency, viscolastic,
electron microscopic and ciliary dynamic studies of the nasal
mucosa which is pseudostratified ciliary columnar in
appearance histologically. The effect of various
morphological forms of nasya (nasal route of drug
administration) on this mucociliary mechanism does offer
new horizons to explore the mode of action of action of
different nasyas in combating the disease Pratishyaya i.e.
rhinosinusitis.
Different morphological forms of Nasyas used in Ayurveda
like oil/lipid based nasal drops, dry fine powder (churna) and
water based nasal drops (Avpeeda nasya/decoctions/infusions
etc.) behaves differently in the nasal cavity when introduced.
This present study intends to explore how these different
morphological forms of nasyas affect the nasal health and
mucociliary mechanism in the patients of Pratishyaya i.e.
Rhinosinusitis with the help of Goldmans saccharin test
JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


which is carried out at various stages of this study. Anu taila
nasya, Shadbindu ghrita nasya, Katphala churna nasya and
Pippalyadi Avapeeda nasya are selected for the study as they
are frequently prescribed in the management of Pratishyaya
i.e. rhinosinusitis in Ayurvedic system of medicine and
conspicuously represent medicated oils, medicated clarified
butter, powder insufflations (errhines) and medicated aqueous
base form of nasal drugs respectively when visualized in
morphological appearance. The formulations scrutinized for
the present study are mentioned in classical Ayurvedic texts
and the fundamentals of Ayurvedic treatment were deemed
respected in every sense in this endeavour but no work has
been found in Ayurvedic literature regarding affect of various
morphological forms of Nasya on mucociliary clearance
mechanism.
MATERIALS AND METHODS
The present work is randomised, single blind, prospective
and single centre study comprising patients of either sex in
the age group 16-70 years. The patients for the research were
selected from ENT OPD, M.S.M. Institute of Ayurveda,
B.P.S. Mahila Vishwavidyalaya, khanpur kalan, Haryana.
Established
and
diagnosed
patients
satisfying
inclusion/exclusion and criteria of assessment were divided
into four trial groups after having written and informed
consent from the patient to participate in the study on a
recorded and standardized proforma. The patient was also
briefed about the research protocol, duration of trial, route of
administration of drug prior to the consent. An official
permission from institutions research ethical committee and
hospital core committee was also taken before the
commencement of the trial (MSM/EC/SKT/2011/16).
Statistical analysis
The data was analysed for statistical significance by using
statistical package for social sciences (SPSS Inc. Chicago,
USA, 17.0). The studentst test( paired) and one way
analysis of variance (ANOVA) were used to analyze the data
for the level of significance using f ratio. The relatedt test
was used to analyze intra group and ANOVA was used to
find inter group differences in pre/post protocol. For all
analysis the p value used for statistical significance was
0.05 and the ANOVA used for the analysis was one way
ANOVA.
Selection of the patients:
Inclusion criterion:
Clinically, endoscopically and radiologically diagnosed
patients of Pratishyaya i.e. rhinosinusitis.
Patients of age group 16-70 years.
Patients having various clinical features depicted in
criteria of assessment later.
Exclusion criterion:
Patients exhibiting gross anatomical distortion of septum
or ostiomeatal complex impeding diagnostic Endoscopy.
Patients presenting with various complications of sinusitis
viz. intra orbital or intra cranial complications.
Patient having concomitant benign or malignant growth
of nasal cavity with rhinosinusitis.
Patients hypersensitive to local anaesthetic agent i.e.
lignocaine.
Criteria of assessment for the present study
Clinical features (Rhinological)
a) Nasal obstruction/blockage
b) Unilateral/bilateral discoloured nasal discharge

c) Decreased sense of smell


d) Itching/irritation of nasal cavity
Clinical features (Non rhinological)
a) Headache
b) Post nasal drip
c) Itching/irritation of the throat
d) Fullness/pressure of the ears
Grading and scoring system of criteria of assessment:
Visual analogue scale (VAS) was used for the grading and
scoring of clinical features in the present study [Table 1].
Investigational parameters
1) Endoscopic parameters
a) Polypoidal changes in the middle meatus
b) Discharge in the middle meatus
c) Oedema of the middle meatus
d) Crusting of the middle meatus
Done by using autoclavable 0o, 4mm rigid nasal endoscope
with videoscopy unit.
Grading and scoring of endoscopic parameters:
For the present study Lund-Kennedy scale was adopted with
practical modifications which has been recommended and
endorsed by various sinonasal studies and also forwarded by
IOS (international otolaryngology society), USA [Table 2].
This classification represents unilateral disease involvement
and hence for bilateral representation this score should be
doubled. Maximum score possible in case of unilateral
presence of a disease is 4x2 =8, and in case of bilateral
presence the maximum score available was 8x2 =16.
2) Radiological parameter
Haziness of the different sinuses. X-ray PNS (OMs view)
with sitting position and open mouth and/or Coronal CT scan
of PNS with 120 KV and 150 mA with 5mm interval and 2
sec. scan time. The slice thickness was 3mm for osteomeatal
unit and 5mm for other sites. The window width was 2000
for the study.
Grading and scoring of radiological parameters:
For the present study Lund-Mackay scale was adopted with
practical modifications which has been recommended and
endorsed by various sinonasal studies and also forwarded by
IOS, USA [Table 3].
This classification represents unilateral disease involvement
and hence for bilateral representation this score should be
doubled. Maximum score possible in case of unilateral
presence of a disease is 4x2 =8, and in case of bilateral
presence the maximum score available was 8x2 =16.
3) Saccharin mucociliary clearance test
Time interval from instillation of saccharin in nasal valve
area to perception of sweet taste by the patient was
nominated as nasal mucociliary clearance time. This test of
nasal mucociliary function was done as per recommendation
of Andersons classical Saccharin test.
Grading and scoring of nasal mucociliary clearance time
Reproducibility of this test was also established by
performing in 8 patients 2 weeks later after evaluating their
initial MCCT. The reproducibility shows insignificant change
from the initially recorded time value [Table 4].
Study design
Diagnosed patients of Pratishyaya i.e. rhinosinusitis
satisfying the inclusion criteria were randomly by table
method, and divided into following four groups. A total of 46
patients were enrolled in the present trial of which 6 patients
were dropout/lost in follow up [Table 5].
JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


Overall results interpretation
Overall results were adjudged in terms of percentage relief
observed by the patients in pre described criteria of
assessment (rhinological, non rhinological, endoscopic and

radiological parameters). This protocol of outcome of


treatment is in accordance to global rating of response to
treatment protocol [Table 6].

Table 1. Grading and scoring system of criteria of assessment


Clinical feature
Nasal obstruction/blockage

0
No obstruction

1
Mild
obstruction

3
Moderately
Severe

4
severe

5
Very
Severe

Mild nasal
discharge

2
Moderate
/bothersome
obstruction
Moderate
/bothersome

Discoloured nasal discharge

No nasal
Discharge

Moderately
Severe

severe

Very
Severe

Decreased sense of
smell/hyposmia

No hyposmia

Mild
hyposmia

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

Itching/irritation of the
nasal cavity

No itching/
Irritation

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

Headache

No headache

Mild
Itching/
Irritation
Mild
Headache

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

Post nasal drip

No post nasal
drip

Mild post
Nasal drip

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

Itching/irritation of the
throat

No itching/
Irritation

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

fullness/pressure of the ears

No fullness/
Irritation

Mild
Itching/
irritation
Mild
Fullness/
irritation

Moderate
/bothersome

Moderately
Severe

severe

Very
Severe

Table 2. Lund-Kennedy scale (modified) for sinonasal studies


Criteria of assessment/ endoscopic
observation
Score 0
Score 1
Polyps in the middle meatus
Absent
Restricted to middle meatus
Absent
Thin and clear discharge
Discharge in the middle meatus
Oedema of the middle meatus
Absent
Mild-moderate
Crusting in the middle meatus
Absent
Mild-moderate
Table 3. Lund-Mackay scale (modified) for radiological parameters
Criteria of assessment/radiological observations
Score 0
Score 1
No haziness
Mild haziness
Maxillary sinus
Frontal sinus
No haziness
Mild haziness
Ethmoidal sinus
No haziness
Mild haziness
Sphenoid sinus
No haziness
Mild haziness

Mucociliary clearance time


(MCCT)
<,=30 minutes
>,=31-<,=40 minutes
>,=41-<,=50 minutes
>,= 50

Trial group
I
II
III
IV

Score 2
Beyond the middle meatus
Thick and purulent
Moderate-severe
Moderate-severe

Score 2
Complete haziness
Complete haziness
Complete haziness
Complete haziness

Table 4. Nasal mucociliary clearance time:


Grading

Scoring

Normal
Mildly increased
Moderately increased
Severely increased

0
1
2
3

Table 5. Study design and preamble of drug protocol


No. of patients
Dosage
Morphological form
of Nasya
(dissociated)
Anu taila nasya
6 drops in each
(lipid)
10
nostril
Shadbindu ghrita
6 drops in each
nasya (lipid)
10
nostril
Katphala churna
1 Shana(total dose of
nasya (powder)
10
4 gms twice daily)
Pippalyadi avpeeda
6 drops in each
nasya (Aqueous
10
nostril
base)

Duration
of trial

Follow
up
For 2 months

21 days
For 2 months
21 days
For 2 months
21 days
For 2 months
21 days

JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


Table 6. Overall results
Percentage relief
Treatment outcome
Cured
100% relief
Markedly improved
>75% relief
Moderately improved
>,= 50% - <,= 75% relief
Slightly improved
>,= 25% - < 50% relief
Unchanged/ unimproved
< 25% relief
Deteriorated/worsened
Negative % relief
Table 7. Effect of Anu taila nasya in 10 patients of rhinosinusitis in group I
n
Mean
X(d)
%
S.D.+/S.E.+/B.T.relief
B.T.
A.T.
A.T.
10
2.6
1.2
1.4
53.84
0.699
0.221
Nasal obstruction
1.9
0.7
1.2
63.15
0.632
0.2
10
Discoloured nasal discharge
2.7
1.4
1.3
48.14
0.675
0.213
9
Decreased sense of smell/hyposmia
10
1.9
0.7
1.2
63.15
0.632
0.2
Itching/irritation of the nasal cavity
7
2.6
1.3
1.3
50
0.675
0.213
Headache
8
2.3
1.2
1.1
47.82
0.316
0.1
Post nasal drip
8
1.8
0.8
1
55.55
0.471
0.149
Itching/irritation of the throat
7
2.3
1.3
1
43.47
0.667
0.211
fullness/pressure of the ears
10
8.1
4.9
3.2
39.5
2.098
0.663
Endoscopy
10
7.1
4.6
2.5
35.21
1.080
0.342
Radiology
10
1.6
0.8
0.8
44.44
0.422
0.133
Mucociliary clearance time
Signs and symptoms

Table 8. Effect of Shadbindu ghrita nasya in 10 patients of rhinosinusitis in group II


Signs and symptoms
n
Mean
X(d)
%
S.D.+/S.E.+/B.T.relief
B.T.
A.T.
A.T.
10
2.7
0.9
1.8
66.66
0.789
0.249
Nasal obstruction
9
2.1
0.8
1.3
61.90
0.823
0.260
Discoloured nasal discharge
9
2.2
0.7
1.5
68.18
0.707
0.224
Decreased sense of smell/hyposmia
9
3.1
2
1.1
35.48
0.316
0.1
Itching/irritation of the nasal cavity
7
2.3
1.1
1.2
52.17
0.422
0.133
Headache
8
2.6
1.2
1.4
53.84
0.699
0.221
Post nasal drip
8
3.1
1.7
1.4
45.16
0.699
0.221
Itching/irritation of the throat
7
2.9
1.7
1.2
41.37
0.789
0.249
fullness/pressure of the ears
10
6.6
4.2
2.4
36.36
2.171
0.686
Endoscopy
10
5.8
3.9
1.9
32.75
0.316
1
Radiology
10
1.6
0.5
1.1
68.75
0.568
0.180
Mucociliary clearance time
Table 9. Effect of Katphala churna nasya in 10 patients of rhinosinusitis in group III
S.D.+/Signs and symptoms
N
Mean
X(d)
%
S.E.+/B.T.relief
B.T.
A.T.
A.T.
10
3.1
1.3
1.8
58.06
0.632
0.2
Nasal obstruction
10
2.2
0.8
1.4
63.63
0.516
0.163
Discoloured nasal discharge
9
2.9
1.2
1.7
58.62
0.483
0.153
Decreased sense of smell/hyposmia
10
3.2
1.1
2.1
65.62
0.876
0.277
Itching/irritation of the nasal cavity
7
2.5
0.6
1.9
76
0.876
0.277
Headache
9
2.8
1.2
1.6
57.14
0.843
0.267
Post nasal drip
9
2.9
1.2
1.7
58.62
0.675
0.213
Itching/irritation of the throat
7
3.6
1.7
1.9
52.77
0.758
0.233
fullness/pressure of the ears
10
6.8
3.5
3.3
48.52
2.003
0.633
Endoscopy
10
6.4
3.4
3
46.87
1.563
0.494
Radiology
10
2.1
0.6
1.5
71.42
0.707
0.224
Mucociliary clearance time
Table 10. Effect of Pippalyadi Avapeeda nasya in 10 patients of rhinosinusitis in group IV
S.E.+/Signs and symptoms
N
Mean
X(d)
%
S.D.+/B.T.relief
B.T.
A.T.
A.T.
10
2.5
1
1.5
60
0.707
0.224
Nasal obstruction
9
2.4
1
1.4
58.33
0.699
0.221
Discoloured nasal discharge
9
2
0.3
1.7
85
0.823
0.260
Decreased sense of smell/hyposmia
9
2.9
0.6
2.3
79.31
0.823
0.260
Itching/irritation of the nasal cavity
7
3
0.9
2.1
70
0.994
0.314
Headache
7
2.7
1.1
1.6
59.25
0.699
0.221
Post nasal drip
9
2.9
1.1
1.8
62.06
0.135
0.359
Itching/irritation of the throat
7
2.8
1.1
1.7
60.71
0.823
0.260
fullness/pressure of the ears
10
7.7
4.2
3.5
45.45
1.841
0.582
Endoscopy
10
8.2
3.8
4.4
53.65
1.350
0.427
Radiology
1.7
0.3
1.4
82.35
0.699
0.221
10
Mucociliary clearance time

t
value

p
value

6.33
6
6.09
6
6.09
11
6.71
4.74
4.82
7.32
6

P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.05
P<0.001
P<0.001
P<0.001

t
value

p
value

7.22
4.99
6.71
11
9
6.33
6.33
4.81
3.5
19
6.13

P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.05
P<0.001
P<0.001

t
value

p
value

9
8.57
11.13
7.58
6.86
6
7.96
8.14
5.21
6.04
6.71

P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001

t
value

p
value

6.71
6.33
6.53
8.83
6.68
7.24
5.01
6.53
6.01
10.31
6.33

P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001

JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


Table 11. One way ANOVA for comparing inter group efficacy of different morphological forms
Sum
of squares
Criteria of assessment(Signs and
df(degree of freedom)
mean sum
of
Symptoms)
square
Between
Within
Between
Within
Between
Within
groups
group
groups
group
groups
group
1
30.6
3
36
0.333
0.850
Nasal obstruction
0.475
21.3
3
36
0.158
0.592
Discoloured nasal discharge
7.4
36.20
3
36
2.47
1.01
Decreased sense of smell/hyposmia
12.20
37.40
3
36
4.07
1.04
Itching/irritation of the nasal
cavity
42.30
3
36
0.89
1.17
2.68
Headache
47.70
3
36
0.03
1.33
0.08
Post nasal drip
Itching/irritation of the throat
fullness/pressure of the ears
Endoscopy
Radiology
Mucociliary clearance time

4.20
2.70
9.80
7.48
1.3

42.20
59.20
144.60
189.30
12.60

3
3
3
3
3

36
36
36
36
36

1.40
0.90
3.27
2.49
0.433

1.17
1.64
4.02
5.26
0.350

Table 12. Mean of various clinical parameters (after treatment value) in all four groups
Signs and symptoms
Shadbindu ghrita
Katphala churna
Anu taila nasya
(Group I)
(Group II)
(Group III)
Nasal obstruction
1.2
0.9
1.3
0.7
0.8
0.8
Discoloured nasal discharge
Hyposmia
1.4
0.7
1.2
Itching/irritation of the nasal cavity
0.7
2
1.1
1.3
1.1
0.6
Headache
Post nasal drip
1.2
1.2
1.2
Itching/irritation of the throat
0.8
1.7
1.2
fullness/pressure of the ears
1.3
1.7
1.7
Endoscopy
4.9
4.2
3.5
4.6
3.9
3.4
Radiology
Mucociliary clearance time
0.8
0.5
0.6

Outcome of the
treatment
Cured
Markedly improved
Moderately improved
Slightly improved
Unchanged
Deteriorated
Total

Table 13. Overall outcome of the treatment in all four trial Groups
Group I
Group II
Group III
(Anu taila nasya)
(Shadbindu Ghrita nasya)
(Katphala Churna nasya)
0
0
0
0
0
0
2
3
8
8
7
2
0
0
0
0
0
0
10
10
10

OBSERVATIONS AND RESULTS


The treatment in this group consists of Anu tail nasya,
Shadbindu ghrita nasya, Katphala churna nasya and
Pippalyadi Avapeeda nasya by dividing 40 in four trial
groups i.e. I, II, III, IV and having 10 patients and each group
receiving different morphological form of nasya i.e. Taila
(medicated Oil), Grita (medicated clarified butter), Churna
(medicated Powder) and Avpeeda nasya (medicated
juice/decoction) respectively. Pairedt test is used for the
evaluation of effectiveness [Table 7, 8, 9, 10] of individual
groups.
Inter group comparison of effectiveness of therapy in
Group I, II, III, IV between different morphological
forms of nasyas:
The treatment in four different groups consists of Anu taila
nasya, Shadbindu ghrita nasya, Katphala churna nasya and
Pippalyadi Avapeeda nasya by dividing 40 patients of this
group into 4 groups of 10 patients and each group receiving
different morphological form of nasya i.e. taila, grita, churna
and decoction respectively. After exploring the effectiveness
of individual effect in all 4 groups by applying paired t test,
it is also important to explore which morphological form of
Nasya has got more efficiency to combat various signs and
symptoms (criteria of assessment) of Pratishyaya i.e.
rhinosinusitis. As in accordance to research methodology

f
ratio

Sig(p)

0.39
0.27
2.45
3.91

0.795
0.848
0.079
0.016

0.76
0.02

0.525
0.996

1.19
0.55
0.81
0.47
1.24

0.326
0.653
0.495
0.702
0.310

Pippalyadi avpeeda
(Group IV)
1
1
0.3
0.6
0.9
1.1
1.1
1.1
4.2
3.8
0.3

Group IV
(Pippalyadi Avpeeda nasya)
0
0
9
1
0
0
10

guidelines in these comparisons of more than two trial


groups, analysis of variance (ANOVA) was all performed on
all criterion of assessment [Table 11].
The critical f value in case of all groups viz. group I-IV was
2.86. Although in all four groups, Anu taila nasya was found
to be most effective in combating discoloured nasal discharge
and itching/irritation of the throat, Shadbindu ghrita nasya
was found to be most effective in combating nasal
obstruction, Katphala churna nasya was found to be most
effective in combating headache, endoscopic parameters, and
radiological parameters, Pippalyadi avpeeda nasya was
found to be most effective in combating hyposmia,
Itching/irritation of the nasal cavity, post nasal drip, fullness
of the ears and mucociliary clearance time reversal. In inter
group comparison none of the four different morphological
forms of nasyas was observed superior to other as the
difference was found to be statistically insignificant in all
clinical parameters (all calculated f ratios are less than the
critical valve) except itching/irritation of the nasal cavity in
which Group II i.e. Shadbindu ghrita nasya was found to be
most effective (f ratio = 3.91). This particular observation
was done on the basis of comparing means of after treatment
in different trial groups [Table 12].

JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


DISCUSSION
Mucociliary clearance (MCC) is a physiological function of
the nasal cavity and respiratory tract to clear locally produced
debris, excessive secretions or unwanted inhaled particles.
For normal MCC to occur it is necessary that the epithelial
cells are intact the ciliary activity and the rheology of mucus
are normal and that the depth and chemical composition of
the periciliary fluid layer is optimal. For many years drugs
has been administered nasally for both topical and systemic
action. Topical administration includes the treatment of
congestion, rhinitis, sinusitis and related allergic or chronic
conditions. Various morphological forms of drugs are used
for nasal drug delivery in experimental studies or in market
i.e. aqueous nasal drops, oil based nasal drops, nasal sprays,
nasal gel pumps, pressurized metered dose inhalers (MDIs)
and dry powder inhalers. 5 Intranasal delivery is currently
being employed in treatments for migraine, smoking
cessation, acute pain relief, osteoporosis, nocturnal enuresis
and vitamin B12 deficiency 6 in modern system of medicine.
Powder form of nasal drug administration and nasal
health
The transportability of mucus from patients with cystic
fibrosis and bronchiectasis has recently been shown to
increase markedly when incubated with dry powders of
hyperosmotic agents such as sodium chloride, urea, mannitol
and glucose. 7 The reason for this is not known but an
alteration in the rheological properties of the mucus was
suggested. Increasing the Osmolarity of the airway fluid by
inhaling a dry-powder preparation increases mucociliary
clearance in healthy subjects. The mechanism of this increase
in clearance remains unclear but it is likely that
hyperosmolarity stimulates ciliary beat frequency indirectly
through intracellular biochemical changes. Dry powder may
also alter the rheological properties of the mucus as it is
reported to increase transportability of mucus. 8
The present study reiterates the up stated mechanism of
enhancing ciliary beat frequency. Although Pippalyadi
Avapeeda nasya was found to be most effective in enhancing
mucociliary beat frequency which was evaluated by
Goldmans Saccharine test among all the groups, Katphala
Churna nasya also increased ciliary beat frequency which is
reflected by analyzing the overall results [Table 13]. This
effectiveness of Katphala Churna nasya can be explained by
the wide spreading property of a powder on inhalation and
inherent trait of possibility of reaching the all important
osteomeatal complex which is the key area in genesis of
rhinosinusitis and always needs to be addressed in each and
every case of rhinological disorders. Modern rhinology
firmly believes that reversal of ciliary beat frequency will
surely reverse the rhinosinusitis as pathology. Katphala
Churna nasya was also found to most effective in
improvement in endoscopic and radiological parameters in
intergroup comparison which is directly related to nasal
mucociliary function.
Oil/lipid base nasal drops and nasal health
Oil/lipid base nasal drops are high viscosity thickened
solutions or suspensions. The advantages of oily nasal drops
includes reduction of post nasal drip due to high viscosity,
reduction of taste impact due to reduced swallowing,
reduction of anterior leakage of the formulation, reduction of
irritation by using soothing/emollient excipients and target
delivery to mucosa for better absorption. 9

The intranasal route may be a viable alternative for selfadministration, whereby these limitations could be overcome.
However, the problem associated with nasal delivery of
aqueous nasal drops is lower retention time of solution in
nasal cavity (15 minutes) resulting in lower bioavailability as
well as lower transfer of drug directly to the brain through the
olfactory pathway. 10 Hence, a formulation that would
increase residence time in the nasal cavity and at the same
time increase absorption of the drug would be highly
beneficial in all respects. The use of lipid base nasal drops
can lengthen the residence time and enhance bioavailability
of drugs delivered to the nasal cavity. 11 Lipid formulations
that provide in situ gelling property in nasal cavity were
designed to delay clearance of the formulations to give
optimum mucoadhesive strength. 12 Further increase in
contact time did not affect the mucoadhesive strength,
whereas decreased contact time resulted in less mucoadhesive
strength resulting from insufficient time for entanglement of
polymer chains with mucin in the nasal cavity. The
microscopic observations indicate that the optimized
formulation has no significant effect on the microscopic
structure of mucosa. The epithelium layer was intact and
there were no alterations in basal lamina with lipid treated
nasal mucosa. Thus lipid formulations seem to be safe with
respect to nasal administration. Lipid base nasal drops
favourable rheological and mucoadhesive properties to allow
the formulation to gel and adhere to the nasal mucosa after
intranasal instillation, thereby decreasing clearance of the
formulation at the site of instillation and enhancing drug
absorption. Oil based nasal drops is a promising nasal drug
delivery system for the sinonasal disorders, which would
enhance nasal residence time owing to increased viscosity
and mucoadhesive characteristics; furthermore, it also
exhibited a permeation enhancing effect.
This present study also supports the fact that mucoadhesive
properties of Anu Taila nasya and Shadbindu ghrita nasya
probably enhance the absorption of the drug by enhancing
contact time with mucociliary belt but unfortunately at the
same time they increases the physical weight on the mucosa
thus deceases the ciliary transport transiently. In the active
stage of inflammation of nasal mucosa i.e. rhinosinusitis
when the nasal and sinuses are already overloaded with
exudates/transudates because of capillary bed dilatation and
active secretion from goblet cells it is not prudent enough to
still overload the already diseased cilias with oil based nasal
drops (both Taila and Ghrita are lipid based nasal drops in
morphological point of view). This is the reason why Nasya
karma (nasal route of drug administration) is condemned in
active stage (Aama avastha) of the diseases in Ayurvedic
classical texts which is well supported by modern researches
also.
In the present study also both lipid based nasal drops i.e. Anu
Taila nasya and Shadbindu Ghrita nasya has got least effect
on nasal mucociliary clearance time, but when inter group
comparison are made although this difference is found to be
statistically insignificant. In overall result comparison also
Anu Taila nasya and Shadbindu Ghrita nasya are found to be
least effective in intergroup comparison. Apart from this fact
radiological and endoscopic parameters are also least effected
by these two trial groups.
Aqueous base nasal drops and nasal health
Aqueous preparations are the most widely used dosage forms
for nasal administration of drugs. They are mainly based on
JPSI 1 (5), Sept Oct 2012, 58-64

Bhardwaj Atul : Therapeutic effects of various morphological forms of Nasya in Pratishyaya


aqueous state formulations. Their humidifying effect is
convenient and useful, since many allergic and chronic
diseases are often connected with crusts and drying of
mucous membranes. Microbiological stability, irritation and
allergic rhinitis are the major drawbacks associated with the
water-based dosage forms because the required preservatives
impair mucociliary function and the reduced chemical
stability of the dissolved drug substance and the short
residence time of the formulation in the nasal cavity are
major disadvantages of liquid formulations. In the present
study Pippalyadi Avpeeda nasya was found to be most
effective in enhancing mucociliary clearance activity and
resolving the signs and symptoms of Rhinosinusitis in Group
IV. This observation is further supported by the fact that this
group is found to be most effective in overall results.
Incomplete absorption of some drugs following oral
administration and first-pass metabolism, results in a low
absolute bioavailability. Unfortunately, potential drugs for
the treatment of most brain diseases are therefore often not
able to cross these barriers. 11 As a result, various drug
delivery and targeting Strategies are currently being
developed to enhance the transport and distribution of drugs
into the brain. Nasal drug delivery is an emerging technique
and even better option to transport the drug directly to brain
bypassing the metabolism. The Delivery from nose to central
nervous system occurs within minutes along with both the
olfactory and trigeminal neural pathways. 13
CONCLUSION
Analysis of mucociliary clearance can provide grounds for
suspected diagnosis of certain diseases of rhinology.
Goldmans saccharin test, which is used for the present study
is a gold standard test for the evaluation of nasal mucociliary
function and hence directly related to nasal health. Saccharine
test is useful for scientific investigations of nasal mucociliary
function, easy to perform, without the need of sophisticated
equipment, and dont cause much subject discomfort.
Different morphological forms of nasyas like lipid based
nasal drops, dry fine powder (Churna) and aqueous based
nasal drops (Avpeeda nasya)) tends to affect the ciliary
epithelium differently in the nasal cavity when administered.
Inhaling a dry-powder preparation increases mucociliary
clearance in patients of Pratishyaya and dry powder may also
alter the rheological properties of the mucus and certainly
increases transportability of mucus. In the present study
Katphala Churna Pradhmana nasya was also found to most
effective in improvement in endoscopic and radiological
parameters in all the groups, which subtly is directly
corresponds to improvement in ciliary function. In the present
study also both lipid based nasal drops i.e. Anu Taila nasya

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and Shadbindu Ghrita snehana nasya has got least effect on


nasal mucociliary clearance in all the trial groups.
This present study also supports the fact that mucoadhesive
properties of Anu Taila Sneha nasya and Shadbindu ghrita
Snehana nasya probably enhance the absorption of the drug
by enhancing contact time with mucociliary belt but at the
same time they increases the physical weight on the mucosa
thus deceases the ciliary transport transiently. Aqueous
base/decoctions form of nasal administration of drugs
frequently requires preservatives which probably impair
mucociliary function and the reduced chemical stability of
the dissolved drug substance and the short effective contact
time of these formulations in the nasal cavity are major
disadvantages of aqueous formulations. The present effort is
a pilot study and the inferences drawn needs to be
strengthened by organizing a large sample study having
different morphological forms of drugs administered through
nasal cavity.
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How to cite this article:


Atul Bhardwaj, Comparative therapeutic effects of various morphological
forms of Nasya (Nasal route of drug delivery) in Pratishyaya (Rhinosinusitis)
with reference to Nasal Muco-ciliary function. J Pharm Sci Innov. 2012;
1(5): 58-64.

JPSI 1 (5), Sept Oct 2012, 58-64

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