Evaluation of NEEM GUARD( A herbal preparation) as a versatile
healer
INTRODUCTION :
“Neem Guard” is a poly
herbal formulation presented in capsule form by M/s. Goodcare
Pharma Pvt. Ltd, Kolkata – 700006. This is a very simple
formula with renowned herbs used in various skin diseases and
found to be immunomodulator in the recent research. For the
purpose of therapeutic evaluation of the said drug in the
patients suffering from skin diseases, the present clinical
trial was initiated.
AIMS AND OBJECTS :
-
To study the response of the drug “Neem
Guard” in skin diseases in general with a motto to study
the specific effect of the drug in particular skin diseases,
if any.
-
To study the immuno-response of the drug
particularly on IgE.
-
To study the safety and toxicity of the
drug, if any.
MATERIAL AND METHODS :
Total 57 patients of skin
diseases were registered during the course of the trial. The
study consists clinical patterns in skin disease and management
of the disease with Neem Guard capsule. Out of 57 cases 35 cases
had completed the total tenure of the treatment and rest of
cases had discontinued at different point of time.
PLACE OF STUDY :
The present clinical study
was undertaken at Shyamadas Vaidya Sastra Pith Hospital attached
to the Institute of Post Graduate Ayurvedic Education &
Research, Kolkata – 700009, during January 2006 to December
2006.
SELECTION OF CASES :
All the patients selected
for the present study were interrogated and detailed history was
recorded in the case record form. All the patients were
thoroughly examined and findings were recorded to establish the
final diagnosis. The selection criteria as noted below were
followed:-
For the purpose
of the present study, patients were registered as per the
following criterias:
(i) Age – 20 to 60 years
(ii) Sex – Both sexes
(iii) Subjective features
(a) Classical
Clinical Features
(iv) Objective Criterias
(a) Routine
Haematological Test
(b) PPBS
(c)
Immunoglobulin (IgE)
DRUG SELECTED FOR THE STUDY :
For the purpose of the
Clinical Trial in this study, “Neem Guard” capsules a poly
herbal compound formulated by M/s. Goodcare Pharma Pvt. Ltd,
Kolkata – 700006, approved by the drug control, West Bengal
has been selected.
METHOD OF DRUG ADMINISTRATION :
The present study was
carried out in two different groups, i.e. trial group and
control group, who were randomly divided.
To all the patients of
trial group Neem Guard capsule the trial drug was given in the
dose of two capsules twice a day, morning and evening with water
for a period of sixty days.
To all the patients of
control group Placebo capsules containing sugar of milk was
given in the similar way as in trial group.
FOLLOW UP :
Follow up study was
conducted in all cases at interval of two weeks for 60 days when
the subjective features were observed. Immunoglobulin E (IgE)
level was estimated before the treatment and after 60 days of
treatment.
CLINICAL PATTERN :
The present study includes
57 cases in total who have symptoms of skin diseases. Out of
this cases 35 cases had completed the full tenure of the
treatment schedule, i.e. 60 days and 22 cases had discontinued
the treatment at different times. Patients suffering from skin
diseases and registered for the present study were divided into
two groups viz. trial group and control group. Trial group
consist 38 patients out of which 25 patients had completed the
full schedule of treatment and 13 patients had dropped out.
Similarly the control group had consisted 19 cases out of which
10 patients had completed the full tenure of treatment and 9
patients had dropped out. The clinical pattern will be discussed
in all 57 cases but result will be analysed on observation of
findings of 35 patients.
Age Incidence:
Patients of the present
study were from 21 to 60 years of age. Patients of different age
group as found in this study are given in Table No. 1
Table No. 1:
Showing the incidence of different age group
|
Sl.No
.
|
Age groups (years)
|
No. of Patients
|
Percentage
|
|
1.
|
21 – 30
|
28
|
49.13
|
|
2.
|
31 – 40
|
17
|
29.82
|
|
3.
|
41 – 50
|
8
|
14.03
|
|
4.
|
51 – 60
|
4
|
7.02
|
|
|
Total
|
57
|
100%
|
Sex Incidence:
Patients of both sexes were
registered for the present study. The sex groups are given in
Table No.2
Table No.2:
Showing the Incidence of Sex
|
Sl.No
. |
Age
groups (years)
|
No.
of Patients
|
Percentage
|
|
1.
|
Male
|
31
|
54.39
|
|
2.
|
Female
|
26
|
45.61
|
|
|
Total
|
57
|
100%
|
Religion Incidence:
Patients of various
religions were included in this study. Patients belonging to
different religion are shown in table No. 3
Table No. 3:
Showing the Incidence of Religion
|
Sl.No. |
Religion
|
No. of Patients
|
Percentage
|
|
1.
|
Muslim
|
25
|
43.85
|
|
2.
|
Hindu
|
28
|
49.12
|
|
3.
|
Christian
|
04
|
7.03
|
|
|
Total
|
57
|
100%
|
Occupational Incidence:
In this study patients
belonging to various occupations were included. The occupational
history as recorded are shown in Table No. 4
Table No. 4:
Showing the Incidence of Occupation
|
Sl.
No. |
Occupation
|
No. of Patients
|
Percentage
|
|
1.
|
Service
|
8
|
14.04
|
|
2.
|
House wives
|
10
|
17.54
|
|
3.
|
Labour
|
18
|
31.57
|
|
4.
|
Cultivator
|
10
|
17.54
|
|
5.
|
Student
|
2
|
3.51
|
|
6.
|
Businessmen
|
6
|
10.53
|
|
7.
|
Misc.
|
3
|
5.27
|
|
|
Total
|
57
|
100%
|
Economical Status
Incidence:
In this study patients of
different income group were recorded and shown in Table No. 5
Table No. 5:
Showing the Incidence of Income Status
|
Sl.
.No. |
Income Status
|
No. of Patients
|
Percentage
|
|
1.
|
LIG
|
40
|
70.17
|
|
2.
|
MIG
|
14
|
24.56
|
|
3.
|
HIG
|
3
|
5.27
|
|
|
Total
|
57
|
100%
|
Educational Status:
When educational status was
enquired, patients of both literate and illiterate groups were
found in this series. The educational status as found is given
in Table No. 6.
Table No. 6:
Showing the Incidence of Educational Status
|
Sl.
No. |
Educational Status
|
No. of Patients
|
Percentage
|
|
1.
|
Illiterate
|
7
|
12.28
|
|
2.
|
Primary
|
15
|
26.32
|
|
3.
|
Madhyamik
|
19
|
33.33
|
|
4.
|
Higher secondary
|
9
|
15.79
|
|
5.
|
Graduate
|
6
|
10.53
|
|
6.
|
Post Graduate
|
1
|
1.75
|
|
|
Total
|
57
|
100%
|
Rural Urban Incidence:
This study included
patients from Urban and Rural areas and shown in Table No. 7
Table No. 7: Showing
the incidence of Rural and Urban
|
Sl.
No. |
Rural / Urban
|
No. of Patients
|
Percentage
|
|
1.
|
Rural
|
17
|
29.83
|
|
2.
|
Urban
|
40
|
70.17
|
|
|
Total
|
57
|
100%
|
Incidence of Diet Habit:
Patients included in the
present study were found to have both types of diet habits
(vegetarian and non-vegetarian), which are presented in Table
No. 8
Table No. 8:
Showing the incidence of Diet Habits
|
Sl.
No. |
Diet Habits
|
No. of Patients
|
Percentage
|
|
1.
|
Non-vegetarian
|
49
|
85.96
|
|
2.
|
Vegetarian
|
8
|
14.04
|
|
|
Total
|
57
|
100%
|
Incidence of Nature of
Work:
In this trial nature of
work were studied which are presented in Table No. 9.
Table No. 9:
Showing the incidence of Nature of Work
|
Sl.
No. |
Nature of Work
|
No. of Patients
|
Percentage
|
|
1.
|
Sedentary
|
25
|
43.86
|
|
2.
|
Moderate
|
28
|
49.12
|
|
3.
|
Hardworker
|
4
|
7.02
|
|
|
Total
|
57
|
100%
|
Incidence of Marital
Status:
In this study married and
unmarried, both patients are included which are presented in
Table No. 10.
Table No. 10:
Showing the incidence of Marital Status
|
Sl.
No. |
Marital Status
|
No. of Patients
|
Percentage
|
|
1.
|
Unmarried
|
21
|
36.85
|
|
2.
|
Married
|
36
|
63.15
|
|
|
Total
|
57
|
100%
|
RESULT AND OBSERVATION:
In this study 57 cases were
registered from the out patient department of Post Graduate
Ayurveda Education and Research, Kolkata – 700009. The
patients were selected following the inclusion, exclusion
criterias. The patients suffering from various type of skin
diseases were included in this study. In this study the patients
were divided in six groups according to the disease. Each of the
disease group was further subdivided into two groups randomly,
viz. trial group and control group. The number of cases as
registered in each disease group are presented in the following
table.
Table No. 11:
Showing various types of skin diseases registered in that study
|
Sl.
No. |
Name of Disease
|
No. of Patients
|
|
Group A (Trial
Group)
|
Group B (Control
Group
|
|
1.
|
Acne
|
6
|
3
|
|
2.
|
Allergic dermatitis
|
6
|
3
|
|
3.
|
Contact dermatitis
|
6
|
2
|
|
4.
|
Scabies
|
2
|
2
|
|
5.
|
Urticaria
|
10
|
5
|
|
6.
|
Wet Eczema
|
8
|
4
|
|
|
Total
|
38
|
19
|
Patients are observed in
terms of subjective improvement before treatment during
treatment and after treatment.
The response of treatment
on subjective criterias as observed in before and after
treatment in six different disease groups of patients are
presented below:
Response of treatment on
Acne:
In this group six patients
were registered in trial group out of which 4 patients had
completed the treatment schedule and three patients in control
group of which two patients had completed the tenure of
treatment. The response of treatment in both group of Acne
patient as observed are presented the Table No. 12.
Table No. 12:
Showing response of treatment on Acne
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Lesion
|
4
|
1
|
75.00
|
2
|
2
|
0.00
|
|
Scales
|
3
|
1
|
66.67
|
2
|
2
|
0.00
|
|
Black Head
|
2
|
1
|
50.00
|
1
|
1
|
0.00
|
|
Scarring
|
3
|
0
|
100.00
|
1
|
1
|
0.00
|
|
Pain
|
1
|
0
|
100.00
|
2
|
2
|
0.00
|
Response of treatment on
Allergic Dermatitis:
In this group six patients
were registered in trial group out of which four patients had
completed the treatment schedule and three patients in control
groups of which two patients had completed the tenure of
treatment. The response of treatment in both groups of Allergic
Dermatitis. Patients as observed are presented the Table No. 13.
Table No. 13:
Showing response of treatment on Allergic Dermatitis
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Itching Sensation
|
4
|
2
|
50.00
|
2
|
2
|
0.00
|
|
Burning Sensation
|
3
|
1
|
66.67
|
1
|
1
|
0.00
|
|
Ulcers
|
2
|
1
|
50.00
|
1
|
1
|
0.00
|
|
Black Heads
|
3
|
1
|
66.67
|
2
|
2
|
0.00
|
Response of treatment on
Contact Dermatitis:
In this group six patients
were registered. In trial group out of which four patients had
completed the treatment schedule and two patients in control
group of which one patient had completed the tenure of
treatment. The response of treatment in both group of contact
dermatitis patients as observed are presented the Table No. 14.
Table No. 14:
Showing response of treatment on Contact Dermatitis
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Eruption
|
4
|
1
|
75.00
|
1
|
1
|
0.00
|
|
Burning Sensation
|
3
|
1
|
66.67
|
1
|
1
|
0.00
|
|
Tingling Sensation
|
2
|
0
|
100.00
|
1
|
1
|
0.00
|
|
Lesion
|
4
|
2
|
50.00
|
1
|
1
|
0.00
|
Response of treatment on
Scabies:
In trial group two patients
were registered in trial group and they had completed the
treatment schedule and 2 patient in control group of which they
had not completed. The response of treatment in both group of
scabies patients as observed are presented the Table No. 15.
Table No. 15:
Showing response of treatment on Scabies
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Pruritus
|
1
|
1
|
00.00
|
0
|
0
|
0.00
|
|
Itching Sensation
|
2
|
1
|
50.00
|
0
|
0
|
0.00
|
|
Burning Sensation
|
1
|
1
|
00.00
|
0
|
0
|
0.00
|
|
Ulcers
|
1
|
1
|
00.00
|
0
|
0
|
0.00
|
Response of treatment on
Urticaria:
In this group 10 patients
were registered in trial group out of which six patients had
completed the treatment schedule and 5 patients in control group
of which two patients completed the tenure of the treatment. The
response of treatment in both group of urticaria patients as
observed are presented the Table No. 16.
Table No. 16:
Showing response of treatment on Urticaria
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Pruritus
|
6
|
2
|
66.67
|
2
|
2
|
0.00
|
|
Itching Sensation
|
4
|
1
|
75.00
|
1
|
1
|
0.00
|
|
Burning Sensation
|
5
|
2
|
60.00
|
2
|
2
|
0.00
|
|
Ulcers
|
4
|
2
|
50.00
|
1
|
1
|
0.00
|
Response of treatment on
Wet Eczema:
In this group eight
patients were registered in trial group out of which 5 patients
had completed the treatment schedule and 4 patients in control
group of which 3 patients had completed the tenure of treatment.
The response of treatment in both group of Wet Eczema patients
as observed are presented the Table No. 17.
Table No. 17:
Showing response of treatment of Wet Eczema
|
Signs &
symptoms
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% improvement
|
|
Pain
|
3
|
2
|
33.33
|
2
|
2
|
0.00
|
|
Ulcers
|
5
|
2
|
60.00
|
3
|
3
|
0.00
|
|
Pruritus
|
5
|
2
|
60.00
|
2
|
2
|
0.00
|
|
Secretion
|
4
|
1
|
75.00
|
3
|
3
|
0.00
|
TOTAL RESPONSE ON SUBJECTIVE FEATURES:
After observation of the
response of treatment in different diseased groups, the response
of the treatment was also observed on individual symptoms. For
this purpose the clinical features of different skin-diseases,
were jointly considered and the observations are presented in
the Table No. 18.
Table No. 18:
Showing the total response of the treatment on subjective
features
|
Sl.
No.
|
Clinical
Feature
|
T r i a l
G r o u p
|
C o n t r o l
G r o u p
|
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% Relief
|
No. of Patients
Before Treatment
|
No. of Patients
After Treatment
|
% Relief
|
|
1.
|
Lesion
|
12
|
5
|
58.33
|
4
|
4
|
No improvement
|
|
2.
|
Scales
|
3
|
1
|
66.66
|
2
|
2
|
No improvement
|
|
3.
|
Black Heads
|
5
|
2
|
60.00
|
4
|
4
|
No improvement
|
|
4.
|
Scaring
|
3
|
0
|
100.00
|
2
|
2
|
No improvement
|
|
5.
|
Pain
|
4
|
2
|
50.00
|
14
|
14
|
No improvement
|
|
6.
|
Itching Sensation
|
6
|
3
|
50.00
|
2
|
2
|
No improvement
|
|
7.
|
Burning Sensation
|
11
|
4
|
63.64
|
3
|
3
|
No improvement
|
|
8.
|
Ulcers
|
8
|
4
|
50.00
|
4
|
4
|
No improvement
|
|
9.
|
Eruption
|
4
|
1
|
75.00
|
1
|
1
|
No improvement
|
|
10.
|
Tingling Sensation
|
2
|
0
|
100.00
|
1
|
1
|
No improvement
|
|
11.
|
Secretion
|
4
|
1
|
75.00
|
3
|
3
|
No improvement
|
|
12.
|
Redness
|
5
|
2
|
60.00
|
2
|
2
|
No improvement
|
|
13.
|
Pruritus
|
12
|
5
|
58.33
|
4
|
4
|
No improvement
|
Apart of the subjective
improvements as observed in different diseases groups, the
objective criteria, i.e, estimation of IgE level was also
estimated before and after treatment. As the number of cases in
disease groups were less so a generalized response of the
treatment on IgE level was observed and presented statistically
in both trial group and control group separately in Table No. 19
and 20 respectively.
Table No. 19:
Showing the response of treatment on IgE level in trial group.
|
IgE
|
Before Treatment
|
After Treatment
|
Decreased Value
|
|
Mean
|
646.12
|
547.32
|
98.80
|
|
SD ±
|
291.29
|
245.82
|
101.35
|
|
SE ±
|
58.25
|
49.16
|
20.26
|
|
t
|
|
|
4.87
|
|
p
|
Highly significant
<0.001
|
Table No. 20:
Showing the response of treatment on IgE level in control group
|
IgE
|
Before Treatment
|
After Treatment
|
Increased Value
|
|
Mean
|
610.00
|
638.90
|
-28.10
|
|
SD ±
|
163.65
|
171.63
|
18.05
|
|
SE ±
|
51.75
|
54.27
|
5.71
|
|
t
|
|
|
-4.92
|
|
p
|
Insignificant
|
From both of the above
tables, it is revealed that positive response was found in trial
group whereas negative response was found in control group. The
mean IgE level in the trial group before treatment was 642.12 IU/ml
was found to reduced to 547.32 IU/ml. The p value was found
highly significant. On the other hand the p value in control
group was insignificant.
DISCUSSION
In the present clinical
study total 57 cases suffering from various types of skin
diseases were included. Out of all the patients 22 patients had
discontinued the total treatment schedule at different time of
treatment and 35 cases (trial group consisted 25 cases and the
control group was 10 patients) had completed the course of
treatment and could be followed up properly during the treatment
schedule of 60 days.
The trial drug “NEEM
GUARD” capsules were given to all the patients of trial
group in the dose of 2 capsules twice daily for a period of 60
days and the control group patients were given the placebo
capsule in the same dose for similar duration.
The effect of the treatment
on the patients of skin diseases was firstly evaluated on the
basis of the specific diseases. The response of the treatment
was assessed in terms of subjective improvement in each disease
groups. In this study patients were registered from six diseased
groups, viz. acne, allergic dermatitis, contact dermatitis,
scabies, urticaria, wet eczema.
In acne group of patients
positive response was noticed in trial group whereas control
group had shown no response. Patients of trial group had shown
100% relief from scarring and pain, 75% relief from lesion,
66.67% from scales and 50% relief from black heads.
In the group of patients
suffering from allergic dermatitis had shown more than 50%
relief in all the subjective features in the trial group whereas
any improvement was not noticed in control group.
The response of treatment
in contact dermatitis has shown 100% improvement in tingling,
75% improvement in eruption, 66.67% in burning sensation and 50%
improvement in lesion among trial group patients. Among control
group of patients any improvement was not noticed.
In scabies group of
patients the response of treatment was very minimum. The trial
group of patients had shown 50% improvement only in itching
sensation, there was no improvement on other subjective
features. The control group of patients had shown no response.
In patients suffering from
urticaria, had shown good response in trial group and zero
response in control group. In trial group 75% improvement from
itching sensation, 66.67% from pruritis, 60% from burning
sensation and 50% from ulcer was observed.
In wet-eczema, good
response was observed in trial group and no response in control
group of patients. In trial group 75% improvement was noticed in
secretion, 60% improvement in ulcer and pruritis and only 33.33%
improvement from pain observed.
When the response of
treatment in individual disease group was compared on the basis
of subjective improvements. It was observed that the response of
treatment with “NEEM GUARD” capsule in Acne was 78.33%, in
contact dermatitis 72.92%, in urticaria 62.92%, in allergic
dermatitis 58.34%, in wet eczema 57.08% and in scabies 12.50%.
In this study we have
observed the effect of treatment on IgE to assess the
immunological response. The effect of treatment on skin diseases
on general was taken into consideration and the response on IgE
level in trial group was found highly significant (p <0.001)
statistically. Similarly the response of treatment on IgE level
in control group was observed and found insignificant.
During the clinical study
of the “NEEM GUARD” capsules in skin diseases any clinical
side effect was not noticed.
CONCLUSION
The product “NEEM GUARD” capsule has been
found to be effective on lowering IgE level particularly in case
of skin diseases as revealed from the study. It has also been
found to be an effective product in some selective skin diseases
like acne, contact dermatitis, urticaria, allergic dermatitis,
wet eczema where the product “NEEM GUARD” capsule can safely
be prescribed. The effect of the product on scabies was not
encouraging. Further longtime study is recommended with specific
skin disease.
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