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Clinically Tested Products


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 :

  1. 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.

  1. To study the immuno-response of the drug particularly on IgE.

  1. 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.