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Clinical Trial Report of STRESS GUARD In Stress Disorder 

INTRODUCTION :

Most people find it difficult to define stress, yet they can experience it often. In general term, stress can be defined as an excessive demand on physical and mental energy, often leading to anxiety anger, distress, fear, irritability and, frustration. This causes in increase in the secretions of pituitary, adrenal and thyroid hormones angiotension secretion from kidneys. All these lead to rise in the cholesterol levels. as well as rise in blood pressure.

A stressful life styles, resulting from day to day problems of finance, education, family and inter personal relationships, as also the demand of work, travel, insecurity job and business, and an urge to exceed and accomplish more than what we already possess-all lead to a degree of stress that results in slow but progressive damage to our different system.

So reducing the stress level can not only protect from the, disease but also enhance our quality of life enormously.

According to latest health report,' stress is said to be one of the largest Killer of man today'. It is now becoming, more accepted as being crucial related to our total health physical, mental and emotional.

Two powerful body systems cope with stress. The nervous system control the rapid body changed, while the endocrine system regulates by releasing hormones into the blood. The adrenal activates the sympathetic nervous system, reducing the normalizing effects of body function. This increases the metabolic rate. Heart-rate, circulation and blood pressure.

AIMS AND OBJECTS:

To evaluation the therapeutic value of "STRESS GUARD" Capsule in the patients of stress disorders, the present clinical trial was undertaken. 'Total 45 cases have included in this study. Who were studies in different groups, viz., trial group and control group. Trial group included 30 patients to whom STRESS GUARD, trial drug was administered. Control group included 15 patients, to whom placebo was administered in the similar way.

MATERIAL AND METHOD :

45 patients of stress disorder 'were 'registered during the course of trial. The study consisted clinical patterns in stress disorder and the management of the particular conditions with "STRESS GUARD" Capsule.

Out of 30 patients of the trial group, 26 cases had completed the full treatment. Schedule (i.e., 60 days) till now and remaining, 4 cases had discontinued the course of treatment.

The control group included 15 patients, out of which, 10 patients, followed the full term treatment (i.e. 60 days) and rest 5 patient had discontinued the course of treatment.

The clinical pattern were studied in all 45 cases for incidence of age, sex (male & female), religion, occupation, economic status, educational status, social status and symptoms of stress disorders following the incidence of blood cortisol, which will be presented in the final reports.

Selection of Cases :

All patients selected for study were interrogated and the details history was recorded in the prescribed case history sheet. All patients were thoroughly examined and findings were, also recorded. To establish the final diagnosis, the blood Cortisol was done and routine examination of Blood, Stool and Urine etc. were also  done. In addition to the observation of subjective features.

Criteria of Final Diagnosis :

All the patients included in clinical study were carefully examined and records were maintained with detail clinical history. The individual who have symptoms of stress disorders with or without raised Blood Cortisol levels were Subjected to clinical trial.

Method of Drug Administration :

The drug "STRESS GUARD" was administered orally to the patients of the trial group in the form of capsules prepared and supplied by "HERBS INDIA", 1,Gupta Lane, Kolkata-700006". The patients of stress disorders taken for the study, were administered 2 capsules (Each 500 mg) twice daily morning and evening with water for a period 60 days.

'Placebo' Capsule was administered orally to the patients of control group. in the similar way which was also prepared and supplied by the 'HERBS INDIA, 1, Gupta Lane, Kolkata-700006'.

Diet :

Any specific diet schedule was not prescribed to the patients.

Follow Up :

Follow up study was conducted in a cases at interval of 15 days for 2 months (60 days), Blood Cortisol was done in each cases before treatment and after 2 months (60 days) of treatment. Cortisol was done in each cases before treatment and after 60 days of treatment.

CLINICAL PATTERN:

The present study consists of total 45 cases who have symptoms of stress disorders and completed the full course of treatment schedule (i.e. 60 days). Though we had registered 45 cases for the present study, out of which 10 cases (5 patient trial group and 5 patient control group) had not completed the full course of treatment. So the clinical pattern will be discussed on 45 cases. But the result will be analyzed observation of the findings of 36 cases (i.e. 26 patient in trial group and 10  patients in control group).

Age Incidents :

Patient of the present study were from 20 to 60 years of age. Patients of different age group 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

21-35

15

33.33

2

36-50

20

44.45

3

51& Above

10

22.22

Total

45

100.00

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.

Sex

No. of Patients

Percentage

1

Male

37

82.22

2

Female

08

17.78

Total

45

100.00

Religion Incidents :
 
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

04

08.89

2

Hindu

38

84.44

3

Christian

03

06.67

Total

55

100.00

Occupation Incidents :

In this study patients belonging to various occupations were included and shown in Table No. 4.

Table No. 4 showing the incidence of Occupation

Sl. No.

Religion

No. of Patients

Percentage

1

Service

09

20.00

2

House-Wives

06

13.33

3

Labour

03

06.67

4

Cultivator

06

13.33

5

Student

09

20.00

6

Businessman

08

17.78

7

Retired

04

8,89

Total

30

100.00

Economic Status :

In this study patients of different income groups 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

L. 1. G.

30

66.67

2

M. 1. G.

15

33.33

Total

45

100.00

Educational Status :
 
When educational status was enquired, patients of both literate and illiterate were found in this series. The educational status as found are given in Table No. 6

Table No. 6 showing the incidence of Educational Status

Sl. No.

Religion

No. of Patients

Percentage

1

Illiterate

3

06.67

2

Primary

16

35.56

3

Madhyamik

7

15.56

4

Higher Secondary

6

13.33

5

Graduate

11

24.44

6

Post Graduate

02

04.45

Total

55

100.00

Rural and urban Incidents :
 
This study included patients from urban and rural areas 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

37.78

2

Urban

28

62.22

Total

45

100.00

Incidence of Diet Habits:

Patients included in the present study were found to have both types of diet habits (Vegetarian & 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

34

75.56

2

Vegetarian

11

24.44

Total

45

100.00

Incidence of Nature of Work :

In this trial study 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

55.55

2

Moderate

12

26.67

3

Hard worker

08

17.78

Total

45

100.00

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

10

22.22

2

Married

35

77.78

3

Hard worker

08

17.78

Total

45

100.00

RESULT AND OBSERVATION :

Response of Treatment in Group A (Trial Group) :

Group-A or Trial group consisted of 30 patients, out of which four patients had discontinued and 26 cases had completed the treatment schedule of 60 days. Patients were observed in terms of subjective criteria's before treatment, during treatment and after treatment. The response of treatment on subjective criteria's as observed before treatment and after treatment are presented below in Table No. 11.

Sl. No.

Symptoms

No. of Pt. before treatment

No. of Pt. after
treatment

Percentage of relief

1

Anorexia

2- 5

16

64.00

2

Apprehension

24

17

70.83

3

Breathlessness

24

16

66.67

4

Constipation

20

16

80.00

5

Diarrhea

26

17

65.39

6

Disinterest of life

24

18

75.00

7

Dizziness

20

14

70.00

8

Fatigue

24

19

79.16

9

Frequency of micturation

20

12

60.00

10

Headache

22

12

54.55

11

Hopelessness/Helplessness

20

14

70.00

12

Inability to work

25

16

64.00

13

Insomnia

20

12

60.00

14

Lack of concentration

20

13

65.00

15.

Lack of self confidence

21

13

61.10

16.

Loss of libido

20

8

40.00

17.

Loss of weight

20

09

45.00

18.

Pain-chest/Abdomen

18

10

55.56

19.

Recurrent thought for death /suicide

18

12

66.67

20.

Slowing of thinking

20

09

45.00

21.

Slowing of speed

21

11

52.39

22.

Skin rashes /ulcer

11

5

45.46

23.

Sweating

22

14

63.64

24.

Tremor

15

09

60.00

It is revealed from the above table that more than 70% of relief was observed in symptoms like apprehension, disinterest of life, fatigue, hopelessness, dizziness and constipation than 50% of relief was observed in symptoms like recurrent thought for death, diarrhea, inability to work, anorexia, sweating, lack of concentration, lack of self confidence, frequency of micturition, insomnia, tremor, pain in chest or abdomen, headache etc. In other symptoms, the relief found was less than 50%.

In all patients who had completed the treatment schedule of 60 days, were also observed in terms of improvements on objective features (Estimation of Blood Cortisol Level AM). The level of cortisol was estimated before treatment and after treatment. The observations are presented statistically in table no. 12.

 

Sl. No.

Schedule of Examination

Mean

SD±

SE±

t

p

1

Before Treatment

289.81

92.20

18.08

16.03

< 0.001

2

Vegetarian

254.92

71.81

14.08

18.11


It is clear from the above table that in trial group (Group A) the mean level of cortisol before treatment was 289.81 ng/dI and reduced to 254.92 ng/dI (mean level) after treatment. The P-value is highly significant.

Response of treatment in Group '13' (Control Group)

Group B or Control Group consisted of 15 patients out of which 5 patients had discontinued the treatment and 10 patients had completed the treatment schedule of 60 days. Patients were observed in terms of subjective features (as in trial group A) before treatment, during treatment and after treatment. The response of the treatment on subjective criteria's as observed before the treatment and after the treatment are presented below in table no. 13.

Table No.13 Showing the response of treatment on subjective features of stress disorder in control group 'Group 13'

Sl. No.

Symptoms

No. of Pt. before treatment

No. of Pt. after treatment

Percentage of relief

1

Anorexia

8

8

00.00

2

Apprehension

6

7

-16.67

3

Breathlessness

6

6

00.00

4

Constipation

8

8

00.00

5

Diarrhea

8

9

-12.50

6

Disinterest of life

5

7

-40.00

7

Dizziness

20

6

-50.00

8

Fatigue

4

5

-25.00

9

Frequency of micturation

7

7

00.00

10

Headache

9

11

-22.22

11

Hopelessness/Helplessness

4

6

-50.00

12

Inability to work

5

6

-20.00

13

Insomnia

10

8

-25.00

14

Lack of concentration

7

8

-14.29

15.

Lack of self confidence

9

9

00.00

16.

Loss of libido

3

3

-00.00

17.

Loss of weight

6

 7

-16.67

18.

Pain-chest/Abdomen

4

4

00.00

19.

Recurrent thought for death /suicide

7

7

00.00

20.

Slowing of thinking

5

5

00.00

21.

Slowing of speed

21

4

00.00

22.

Skin rashes /ulcer

2

2

00.00

23.

Sweating

6

7

-16.67

24.

Tremor

3

3

-00.00

The responses of treatment on subjective features in patients of Group B (control group) as revealed from the above table, it is found that there was no relief in subjective features. Moreover, negative relief was observed in some of the subjective features like dizziness, helplessness, insomnia, fatigue, disinterest of life, headache.

In the patients of group B (control group) who had completed the treatment schedule of 60 days, were also observed in terms of improvements on objective features (estimation of Blood Cortisol level-AM). The level of cortisol was estimated before treatment and after treatment. The observations are presented statistically in table no.14.

Table No. 14 Showing response of treatment on cortisol level (AM ng/dl) of blood in patients of stress disorders in control group B (N=10).

Sl. No.

Schedule of Examination

Mean

SD±

SE±

t

p

1

Before Treatment

266.30

88.54

27.10

16.03

10.93

2

Vegetarian

311.40

86.55

8.66

18.11

35.96

The response of treatment on cortisol level in group B (control group) shows that the mean cortisol level which was 266.30 ng/dI before treatment had increased upto 311.40 ng /dI after treatment. This indicates that there was no improvement in control group.

DISCUSSION:

In the Present clinical study, 45 patients suffering from stress-disorders were included. The total cases were a randomly divided into two groups viz. (1) Group A (Trial group) consisted of 30 patients to whom "STRESS GUARD", the trial drug was given for a period of 60 days; (2) Group B (Control Group) consisted of 15 cases to whom placebo was given for 60 days. Out of these cases 4 cases could not be followed in Group A (Trial Group) and 5 cases in Group B (Control Group). 26 cases in Group A (Trial Group) and 10 cases in group B (Control Group) could be followed up properly.

In trial group to all the patients "STRESS GUARD" Capsules (each 500 mg) was given in the dose of 2 capsules twice daily morning and evening with water for a period of 60 days. Similarly in Control Group to all the cases 'PLACEBO' capsule (each 500 mg) was given in the dose of 2 caps twice daily morning and evening with water.

The effect of treatment on both the group of patients were assessed at the end of the treatment. The response of the treatment was observed mainly on subjective improvements. At the end of the treatment, the result was assessed in terms of excellent improvement, good improvement and poor improvement. The patients were included under good response group when they showed more than 70% relief of subjective features. The patients were included under good response group when they showed between 51 to 70% relief of subjective feature and patients showing relief of subjective features below 51% were leveled under poor response group. In consideration to the effects of the drug in Trial Group 19.23% cases were included under excellent response group, 69.23% under good response groups and 11.54% in poor response group.

In the trial group in most of the cases of the cortisol level was found to be reduced. The effects of the treatment on cortisol levels in patient of group A (Trial Group) have been statistically analyzed and found highly significant (P < 0.001).

Any improvement in patients of Control Group (Group B) was not found when the effect of the treatment on subjective criteria's were analyzed. When the effect on cortisol level was observed, it was seen that the mean cortisol value which was 266.30 ng/dI before treatment had increased up to 311.40 ng/dl after treatment.

When the response of treatment in both the groups were analysed and compared, it is revealed that, there is definite improvement in the patients of Group A or Trial Group, treated with "STRESS GUARD".

During the clinical study of the 'STRESS GUARD' Capsules, none of the patients had shown any side effects.



CONCLUSION:

The drug "STRESS GUARD" Capsule has been found to be an effective drug on stress disorders. The result in the trial group has shown encouraging results. After 60 days of treatment along with the improvements of the subjective criterias significant response was also noticed on objective criteria, particularly on serum cortisol level in trial group. Hence 'STRESS GUARD' can safely be prescribed in cases of stress.

ACKNOWLEDGEMENT

We sincerely acknowledge Dr. P.K. Mukherjee, Project Officer and Assistant Director (Ayurveda) for sanctioning permission to conduct the trial at Institute of Post Graduate Ayurvedic Education & Research at Shayamadas Vaidyasastrapith Hospital, Kolkata - 700009. We further acknowledge M/s. HERBS INDIA, 1, Gupta Lane, Kolkata -700006, for their financial support for this trial.

Research Scholar
 Dr. Mofizuddin Ahmed
Co-investigator
Dr. P.C. Tripathi



Principal Investigator
Dr. B. P. Shaw