Clinical Trial Report of DIABETGUARD GRANULES
INTRODUCTION:
Diabetes mellitus is a very
common constitutional disease known since the ancient days. It
is a heterogeneous primary disorder of carbohydrate metabolism
with multiple etiological factors that generally involve
absolute or relative insulin deficiency or insulin resistance or
both. Due to advancement of the present civilization,
urbanization, physical inactivity, over nutrition, chronic under
nutrition, obesity, stress, drug abuses etc. the diabetes is
becoming commoner day by day. It has world wide distribution. So
far about 98.9 million sufferers of diabetes mellitus are in the
world of which Asian countries contribute 46.9 millions, almost
50% diabetes of the world. About 20 million are in India.
AIM AND OBJECT:
To evaluate the therapeutic
value of DIABET GUARD granules in the patients of DIABETES
MELLITUS, the present clinical trial was undertaken. Total 59
cases have been registered for this study. Trial group included
46 cases to whom DIABET GUARD granules, trial product was
administered and 13 cases included under control group to whom
placebo was given.
MATERIAL AND METHOD:
Total 59 patients of
DIABETES MELLITUS were registered during the course of trial.
The study consists clinical patterns in Diabetes – Type 2 and
the management of the particular condition with the DIABET GUARD
granules and the effect of placebo in a control group. In this
trial 59 cases were registered, among them 40 cases completed
the total tenure of treatment and 19 cases had discontinued. 59
cases were randomly divided in two groups, viz trial group and
control group. Trial group consisted of 46 cases, out of which
14 cases had dropped out. Control group consisted of 13 cases,
out of which 5 cases had discontinued during the study period.
The clinical patterns were
studied in all the 59 cases for incidence of Age, Sex, Religion,
Occupation, Economic Status, Education and Social Status etc.
SELECTION OF CASES:
All the patients selected
for the study were interrogated and detailed history were
recorded in the case record form. All the patients were
thoroughly examined and findings were recorded. To establish the
final diagnosis the fasting blood sugar and the Post Prandial
Blood Sugar (after 75gm of glucose intake), urine for sugar,
were 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 diabetes with raised Blood Sugar (Post Prandial)
levels above 180 mg/dl were subjected to clinical trial.
METHODS OF DRUG ADMINISTRATION:
The drug DIABET GUARD
granules was prepared and supplied by Goodcare Pharma Pvt. Ltd.
for the study in this trial. The patients taken for the study
were suffering from diabetes type 2 and the drug was
administered in the dose of 1 tsf (6gm) twice daily before meal
orally for 90 days with water, to all the cases of trial group.
To all the patients of control group placebo was given in a
similar pattern.
FOLLOW UP:
Follow up study was
conducted in all cases at interval of 4 week for 3 months (90
days). Blood Sugar, Fasting & Post Prandial, urine sugar
level, body weight was done in each before treatment and after
each month of treatment for 3 months. Finally the result was
compared with pretreatment and post treatment observation.
CLINICAL PATTERN:
The present study consists
of total 59 cases who have symptoms of diabetes – among them
40 cases completed the full course of treatment schedule (i.e.
90 days) and 19 cases had not completed the full course of
trial. But the clinical pattern will be discussed in all 59
cases. The result will be analyzed on observation of the
findings of 40 cases.
Age Incidence:
Patients of the present
study were from 31 to 70 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.
|
31 – 40
|
15
|
25.42
|
|
2.
|
41 – 50
|
22
|
37.29
|
|
3.
|
51 – 60
|
14
|
23.73
|
|
4.
|
61 – 70
|
08
|
13.56
|
|
Total
|
59
|
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
|
38
|
64.40
|
|
2.
|
Female
|
21
|
35.60
|
|
Total
|
59
|
100.00
|
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
|
42.38
|
|
2.
|
Hindu
|
19
|
32.20
|
|
3.
|
Christian
|
15
|
25.42
|
|
Total
|
59
|
100.00
|
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
|
14
|
23.73
|
|
2.
|
Housewives
|
9
|
15.25
|
|
3.
|
Labour
|
9
|
15.25
|
|
4.
|
Cultivator
|
6
|
10.17
|
|
5.
|
Student
|
3
|
05.09
|
|
6.
|
Businessmen
|
13
|
22.03
|
|
7.
|
Retired
|
5
|
08.48
|
|
Total
|
59
|
100.00
|
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
|
26
|
44.07
|
|
2.
|
MIG
|
21
|
35.59
|
|
3.
|
HIG
|
12
|
20.34
|
|
Total
|
59
|
100.00
|
Educational Status:
When educational status was
enquired, patients of both literate and illiterate group 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.
|
Educational Status
|
No. of Patients
|
Percentage
|
|
1.
|
Illiterate
|
14
|
23.73
|
|
2.
|
Primary
|
11
|
18.64
|
|
3.
|
Madhyamik
|
11
|
18.64
|
|
4.
|
Higher Secondary
|
10
|
16.95
|
|
5.
|
Graduate
|
07
|
11.87
|
|
6.
|
Post Graduate
|
06
|
10.17
|
|
Total
|
59
|
100.00
|
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
|
23
|
38.98
|
|
2.
|
Urban
|
36
|
61.02
|
|
Total
|
59
|
100.00
|
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
|
83.05
|
|
2.
|
Vegetarian
|
10
|
16.95
|
|
Total
|
59
|
100.00
|
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
|
30
|
50.85
|
|
2.
|
Moderate
|
22
|
37.29
|
|
3.
|
Hardworker
|
07
|
11.86
|
|
Total
|
59
|
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
|
12
|
20.34
|
|
2.
|
Married
|
47
|
79.66
|
|
Total
|
59
|
100.00
|
RESULT AND OBSERVATION:
Response of treatment in
trial group (Group A)
Trial group consisted of 46
patients, among them 32 cases had completed the full tenure of
trial and 14 cases had not completed the full trial. All the
cases were given the DIABET GUARD granules in the dose of 1 tsf
(6gm) twice daily before meal for 90 days, with water.
Patients were observed in
terms of subjective improvements before treatment, during
treatment and after treatment. The response of treatment of
subjective criterias as observed before treatment and after
treatment in 32 cases are presented below in table no. 11
Table No. 11 :
Showing the response of treatment on subjective features of
Diabetes Mellitus (n=32) in trial group.
|
Sl. No.
|
Symptoms
|
No. of patients
before treatment
|
No. of patients
relieved after treatment
|
Percentage of
relief
|
|
1.
|
Polyurea
|
28
|
19
|
67.86
|
|
2.
|
Polydipsia
|
27
|
18
|
66.67
|
|
3.
|
Poly Phagia
|
22
|
16
|
72.73
|
|
4.
|
Pruritus
|
14
|
10
|
71.43
|
|
5.
|
Vertigo
|
28
|
19
|
67.86
|
|
6.
|
Inability to work
|
24
|
17
|
70.83
|
|
7.
|
Tingling Sensation/
Numbness
|
22
|
13
|
59.10
|
|
8.
|
Excessive weight
losses
|
26
|
15
|
57.10
|
|
9.
|
Excessive
perspiration
|
28
|
18
|
64.28
|
|
10.
|
Excessive sleep
|
20
|
14
|
70.00
|
|
11.
|
Excessive tiredness
|
24
|
16
|
66.67
|
|
12.
|
Loss of Memory
|
20
|
14
|
70.00
|
|
13.
|
Loss of libido
|
26
|
4
|
15.39
|
|
14.
|
Joint pain
|
25
|
17
|
68.00
|
|
15.
|
Malaise
|
28
|
20
|
71.43
|
In all patients who had
completed the treatment schedule of 90 days, were also observed
in term of improvements on objective features like estimation of
fasting blood sugar. Post prandial blood sugar level, urine
sugar level body weight. All the objective features was
estimated before treatment and after treatment. The observations
are presented statistically in table no. 12 to 15.
Table No. 12 :
Showing the response of treatment on Fasting Blood Sugar level
in patients of diabetes mellitus (n= 32) in trial group.
|
FBS
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
242.06
|
146.53
|
95.53
|
|
SD ±
|
59.002
|
57.50
|
13.38
|
|
SE ±
|
10.43
|
10.16
|
2.36
|
|
t
|
|
|
40.47
|
|
p
|
|
|
> 0.001
|
It is revealed from the
above table that the mean fasting blood sugar level was 242.06
mg/dl before treatment and that was reduced to 146.53 mg/dl
after treatment and the p value is highly significant
(>0.001).
Table No. 13 :
Showing the response of treatment on post prandial blood sugar
level in patients of diabetes mellitus (n=32) in trial group.
|
PPBS
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
300.34
|
186.40
|
113.56
|
|
SD ±
|
69.62
|
67.40
|
19.61
|
|
SE ±
|
12.30
|
11.91
|
3.46
|
|
t
|
|
|
32.82
|
|
p
|
|
|
>0.001
|
From the above table it is
clear that mean PP Blood Sugar level was 300.34 mg/dl before
treatment which reduced to 186.40 mg/dl after treatment and the
decreased mean PPBS is 113.56 mg/dl and the p value is highly
significant (>0.001).
Table No. 14 :
Showing the response of treatment on urine sugar in patients of
diabetes mellitus (n=32) in trial group.
|
Urine Sugar
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
2.96
|
1.09
|
1.87
|
From the above table it is
revealed that the mean urine sugar before treatment was 2.96
mg/dl which reduced to 1.09 mg/dl after treatment. So the
improvement was 63.17%.
Table No. 15 :
Showing the response of treatment on Body weight in patients of
diabetes mellitus (n=32) in trial group.
|
Body Weight
|
Before treatment
|
After treatment
|
Increased value
|
|
Mean
|
48.00
|
50.34
|
2.34
|
|
SD ±
|
7.57
|
7.49
|
0.78
|
|
SE ±
|
1.33
|
1.32
|
0.13
|
|
t
|
|
|
18.02
|
|
p
|
|
|
>0.001
|
From the above table it is
clear that the mean body weight was 48.00 kg before treatment
which increased to 50.34 kg after treatment and the p value is
highly significant (>0.001).
Response of treatment in
control group (Group B)
Control group (Group B)
consisted of 13 patients out of which 5 patients had
discontinued the treatment and 8 patients had completed the
treatment schedule of 90 days. All the patients were given
placebo in the dose of 1 tsf (6 gm) twice daily before meal.
Patients were observed in terms of subjective features before
treatment during treatment and after treatment. The response of
the treatment on subjective criterias as observed before the
treatment and after the treatment in 8 cases are presented in
table no. 16.
Table No. 16 :
Showing the response of treatment on subjective features of
Diabetes Mellitus (n=8) in control group.
|
Sl.No.
|
Symptoms
|
No.of patients
before treatment
|
No.of patients
relieved after treatment
|
|
1.
|
Polyurea
|
05
|
00
|
|
2.
|
Polydipsia
|
06
|
00
|
|
3.
|
Poly Phagia
|
07
|
-01
|
|
4.
|
Pruritus
|
06
|
-01
|
|
5.
|
Vertigo
|
06
|
00
|
|
6.
|
Inability to work
|
04
|
-01
|
|
7.
|
Tingling Sensation/
Numbness
|
06
|
00
|
|
8.
|
Excessive weight
losses
|
07
|
00
|
|
9.
|
Excessive
perspiration
|
06
|
-01
|
|
10.
|
Excessive sleep
|
06
|
00
|
|
11.
|
Excessive tiredness
|
06
|
00
|
|
12.
|
Loss of Memory
|
05
|
|
|
13.
|
Loss of libido
|
07
|
00
|
|
14.
|
Joint pain
|
06
|
-01
|
|
15.
|
Malaise
|
07
|
00
|
The responses of treatment
on subjective features in patients of control group as shown in
the above table, it is found that there was no relief in
subjective features. Moreover, negative response was noted in
some of the subjective features like polyphagia, pruritus,
inability to work, excessive perspiration and joint pain etc.
In the patients of control
group who had completed the treatment schedule of 90 days. Were
also observed in terms of improvements on objective features
like estimation of fasting blood sugar, post prandial blood
sugar, urine sugar, body weight. All the objective features were
estimated before treatment and after treatment. The observations
are presented statistically in table no. 17 to 19.
Table No. 17:
Showing the response of treatment on Fasting Blood Sugar level
in patients of diabetes mellitus (n=08) in control group.
|
FBS
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
189.00
|
230.00
|
-41.00
|
|
SD ±
|
13.09
|
27.61
|
17.49
|
|
SE ±
|
04.62
|
09.76
|
06.18
|
|
t
|
|
|
-06.63
|
|
p
|
|
|
insignificant
|
It is revealed from the
above table that the mean fasting blood sugar level was 189.00
mg/dl before treatment and that was increased to 230.00 mg/dl
after treatment and the p value is insignificant.
Table No. 18:
Showing the response of treatment of post prandial blood sugar
level in patients of diabetes mellitus (n=08) in control group.
|
PPBS |
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
253.50
|
284.87
|
-31.37
|
|
SD ±
|
35.07
|
38.65
|
11.57
|
|
SE ±
|
12.40
|
13.66
|
04.09
|
|
t
|
|
|
-07.67
|
|
p
|
|
|
insignificant
|
From the above table it is
clear that mean PP blood sugar level was 253.50 mg/dl before
treatment which increased to 284.87 mg/dl after treatment and
the increased mean PPBS is 31.37 mg/dl and the p value is
insignificant.
Table No. 19:
Showing the response of treatment on urine sugar in patients of
diabetes mellitus (n=08) in control group.
|
Urine Sugar
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
02.25
|
03.25
|
-01.00
|
From the above table it is
revealed that the mean urine sugar before treatment was 02.25
mg/dl which increased to 03.25 mg/dl after treatment. So there
was no improvement noticed.
DISCUSSION :
In the present study 59
patients suffering from diabetes mellitus (type 2) were
included. The total cases were randomly divided in two groups
viz. trial group (Group A) and control group (Group B). Trial
group consisted of 46 patients to whom DIABET GUARD granules,
the trial drug was given for a period of 90 days. In the present
series out of 46 cases of trial group 14 cases had discontinued
the treatment and 32 cases could be followed up properly during
the treatment schedule (i.e. 90 days).
Control group (Group B)
included 13 patients, out of which 5 patients had discontinued
the treatment and 8 patients could be followed for 90 days.
To all the patients of the
trial group DIABET GUARD granules, the trial drug was given in
the dose of 1 tsf (6 gm) twice daily before lunch and dinner
with water, orally for a period of 90 days. In control group, to
all the cases placebo granules were given in the dose of 1 tsf
(6 gm) twice daily before lunch and dinner with water, orally
for a period of 90 days.
The effect of the treatment
on both these group of patients were evaluated during the
treatment and assessed at the end of the treatment. The response
of the treatment was observed on subjective improvement and
objective improvements. At the end of the treatment, the result
was assessed in term of excellent improvement, good improvement
and poor improvement. The patients were included under excellent
response group when they showed more than 70% relief of
subjective features with reduction of PPBS. The patients were
included under good response group when they showed relief of
subjective features between 51 to 70% relief with reduction of
PPBS. Patients showing relief of subjective features below 51%
and reduction of PPBS were labeled under poor response group. In
consideration to the effect of the drug in trial group 31.25%
cases were included under excellent response group, 43.75% under
good response group and 25% under poor response group.
In this study it was
interesting to note that almost all the cases had responded to
the treatment which was observed by reduction of the blood sugar
level. The effect of the treatment on fasting and post prandial
blood sugar level, in all the patients of the study have been
statistically analysed and found highly significant. The mean
fasting blood sugar level which was 242.06 mg/dl before
treatment was reduced to 146.53 mg/dl after treatment. Similarly
the PPBS before treatment was 300.34 mg/dl and reduced to 186.40
mg/dl after treatment.
Any improvement in patients
of control group was not found when the effect of the treatment
on subjective criterias and objective criterias were analysed.
The response observed was insignificant.
When the response of the
treatment in both the groups were analysed and compared it was
revealed that there is definite improvement in the patients of
diabetes mellitus treated with DIABET GUARD granules.
During the clinical study
of the DIABET GUARD granules any clinical toxicity was not
recorded.
CONCLUSION :
The drug “DIABET GUARD” granules has been
found to be an effective drug on diabetes mellitus type 2 the
result has shown encouraging result after 4 week of treatment
particularly on the subjective criterias. After 90 days of
treatment along with the improvement of subjective criterias
significant response was also noticed on objective criterias,
particularly on PPBS level. Hence, “DIABET GUARD” granules
can be prescribed in diabetes mellitus type 2.
|
