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Scientifically Proven

Clinically Tested

Toxicologically Tested

EXCLUSIVE BENEFITS OF BGR-34


Potential DPP-4 inhibitor with
cardioprotective action
Scientifically proven,
optimized formulation
Regulates
glucose homeostasis

Enriched with 34 vital


Phytoconstituents, derivatives

C.S.I.R.

Council of Scientific
& Industrial Research

Converts
proinsulin to insulin

MINISTRY OF SCIENCE & TECHNOLOGY

BGR-34 contributes to the


maintenance of normal
Daruharidra
Improves health
& functioning
of pancreas,
naturally.

Vijaysar
Rich in flavonoids ,
strengthens the cells
and help maintain
normal blood
glucose level

Giloy
A unique herb to
improve immunity.
Helps improve
resistance to
infections

Exerts
Anti-oxidant Action

BLOOD GLUCOSE

METABOLISM
and Restores Quality of Life

Majeeth
Powerful anti-oxidant
activity. Helps protect
vital organs from
oxidative damage

Methika
One of the
best sources of
Micro-nutrients.
Nourishes & tones
the vital organs

Gudmar
Maintains
post-prandial
blood glucose level
by delaying glucose
absorption

Dosage : Tablets : 2 tablets twice a day, Granules: teaspoonful twice a day, half
half an hour before meals
an hour before meals
or as directed by Physician.

Brings Revolution, with a

BREAKTHROUGH PHYTORESEARCH
of the Decade

also reduces the chances of


Long Term Complications
AIMIL/PD/LIT20/BGR/Q3/2015

Reduces level of
glycosylated Hb

JOINTLY DEVELOPED BY
THE SCIENTISTS OF

CSIR- NBRI & CSIR- CIMAP


NATIONAL BOTANICAL
RESEARCH INSTITUTE
(LUCKNOW)

CENTRAL INSTITUTE OF
MEDICINAL & AROMATIC
PLANTS, (LUCKNOW)

RESEARCH TECHNOLOGY TRANSFERRED TO

BLOOD
GLUCOSE
REGULATOR
TO MANAGE THE LIVES OF SUFFERING DIABETICS

lh,lvkbZvkj&jk"Vh; ouLifr vuqla/kku laLFkku


CSIR-National Botanical Research Institute
oSKkfud rFkk vkS|ksfxd vuqla/kku ifjkn] ubZ fnYyh
jk.kk izrki ekxZ] y[ku & 226 001] m-iz-] Hkkjr
(Council of Scientific & Industrial Research, New Delhi)
Rana Pratap Marg, Lucknow- 226 001, U. P., India

MkW- pUnz 'ks[kj ukSfV;ky

VkVk buksos'ku QSyks] ,Q,u,] ,Q,u,,llh] ,Q,u,,,l

funs'kd
Dr. Chandra Shekhar Nautiyal
TATA Innovation Fellow, FNA, FNASc, FNAAS

Director

FOREWORD

Launching Ceremony at Vigyan Bhawan,


New Delhi.
Hon'ble vice president of India
Mr. M. Hamid Ansari with
Dr. C. S. Nautiyal, Director, CSIR-NBRI.
Phones : (Off.) (0522) 2205848, EPABX Phone : (0522) 2297800 to 2297999 Fax : (0522) 2205839, Post Box No. 436, Lucknow
e-mail : director@nbri.res.in, csnnbri@yahoo.com, Website : http://www.nbri.res.in

Research product of MINISTRY OF SCIENCE & TECHNOLOGY

BLOOD GLUCOSE REGULATOR


C.S.I.R.

Insulin

Glucose

Acts as DPP-4 inhibitor to


effectively manage Diabetes

Strengthens -cell functional


Capacity

Inhibition of DPP-4 provides improved


glucose tolerance, increases insulin
secretion in response to oral glucose and
decreases blood glucose level effectively. Berberis aristata (Daruharidra)

Protects -cells from damage, promotes


repairative regeneration of cells, thus
increases insulin production by improving
the functional capacity of -cells- Gymnema
sylvestre (Gudmar)

Modulates Insulin release,


exerts insulinogenic effect
Increases the c AMP content of the -islets, which
helps in repair and revival of -cells of pancreas,
increases insulin release & converts
proinsulin to insulin. - Pterocarpus
marsupium (Vijaysaar)

Insulin Receptor

Glucose
Channel

Normal
body cell
Body
cell with
Diabetes

Increased Blood
Glucose Level

to manage the lives of suffering Diabetics

Manages glucose
absorption &
uptake
Supplements bioactive
constituents like
galactomannan, reduces
post prandial glucose level
because of its property to
delay intestinal absorption
of glucose and benefits in
blood glucose management Trigonella foenum-graecum
(Methi)

Exerts Cardioprotective Action


Boosts body defence system & anti-oxidant
mechanism to protect the cardiovascular
system by supplementing essential phytoconstituents - Tinospora cordifolia (Giloe)

Nourishes & Strengthens


vital organs
Regulates blood glucose through mitigating
oxidative stress, promoting insulin secretion.
It helps to restore anti-oxidant enzymes like
SOD, catalase, glutathione peroxidase etc. to
nourish & protect the vital organs - Rubia
cordifolia (Majeeth).

What is special
about BGR-34?
BGR-34 is a novel,
natural DPP-4 inhibitor
and unlike other DPP-4
inhibitors in market, BGR34 exerts cardioprotective
action. It also exerts
powerful anti-oxidant
action, helps prevent
development of triopathic complications. An
optimized concentration
of synergistically acting
extracts makes BGR-34
highly efficacious in
management of
Diabetes.

Research product of MINISTRY OF SCIENCE & TECHNOLOGY

Improves Insulin action by activating AMPK

C.S.I.R.
Effectively controls diabetes by inhibiting DPP-4
(GLP-1 & GIP)

Berberine from Berberis aristata (Daruharidra) has been shown to have a


significant beneficial effect on diabetes mellitus type-2, and may be as effective
as metformin (500 mg /day). Berberine acts through several mechanisms,
including insulin mimicking action, improving insulin action by activating
AMPK, reducing insulin resistance through protein kinase C-dependent upregulation of insulin receptor expression inducing glycolysis, and on incretins
by promoting GLP-1 secretion and modulating its release, by inhibiting DPP-4.
(Natural Medicine Journal 2(10), 5-6, 2010)

Berberine (Berberis aristata)


Acts as
DPP-4 inhibitor

Increases insulin secretion and improves oral glucose tolerance


Berberine from Berberis aristata (Daruharidra) has been shown to
antagonize the hyperglycaemic action of glucose and the
gluconeogenic action of alanine in experimental subjects and on
hepatocyte cell lines. It seems to decrease insulin resistance by
raising insulin sensitivity. The DPP IV inhibitory activity could explain
the anti-diabetic activity of berberine including the decrease of
fasting blood glucose level, the increase in insulin secretion and the
improvement in oral glucose tolerance tests (OGTT) was observed in
experimental subjects. (Journal of Enzyme Inhibition and Medicinal Chemistry, 24(5): 1061-

Blocks DPP4 enzymes activity


Increases
GLP-1 level
(A Gut hormone)

1066, 2009 )

DPP-4 on brush
border of intestine

Provides Protection from


oxidative damage

GLP-1
GIP
Retards glucose
absorption

Controls
Blood Sugar Level

80

% Inhibition

Increases
Glucose uptake
& Storage by
muscles

Increases
insulin secretion
Enhances
Insulin sensitivity

% Inhibition

(J Natural Products, 4; 158-163, 2011)

Decreases glucose
production by liver
(Decreases gluconeogenesis)

DPP-4 : Dipeptidyl peptidase-4


GLP-1 : Glucagon-like peptide-1
AMPK : Adenosine monophosphate-activated
protein kinase
GIP : Gastric inhibitory peptide

Reduces feeling
of hunger
(Increases satiety)

In a study Berberis aristata (Daruharidra) extract showed high DPP-IV


inhibitory potential. The reason to observe high inhibitory activity of Diprotin
A, the standard DPP-4 inhibitor, was due to its tripeptide specificity and purity.
Berberine significantly reduced fasting blood glucose, HbA1c and
triglycerides in type 2 diabetic patients. It lowered blood glucose level
through increasing insulin receptor expression. Berberine is
preferred over metformin for hyperglycaemic patients with liver
diseases.

60
40
20
0
-1.0

80
60
40
20
0

-1.5

0.0

0.5

1.0

Log Conc.

Figure-1: DPP-4 inhibitory activity of Diprotin A,


the standard DPP-4 inhibitor

0.0

0.5

1.0

1.5

2.0

Log Conc.
Figure-2: DPP-4 inhibitory activity of Berberis aristata ext.

Research product of MINISTRY OF SCIENCE & TECHNOLOGY

Converts Pro-insulin
to insulin

C.S.I.R.
Repairs & Revives -cells, Enhances Insulin Release
A study conducted with Pterostilbene, a constituent derived from Pterocarpus marsupium
(Vijaysar) showed hypoglycemic activity in experimental subjects because of presence of tannates
in the extract. Marsupin, pterosupin and liquiritigenin obtained from
vijaysar showed antihyperlipidemic activity. ()Epicatechin, its active
Flavonoid
principle, has been found to be insulinogenic, enhancing insulin release
fraction from
by converting proinsulin to insulin. Like insulin, () epicatechin
stimulates oxygen uptake in fat cells and tissue slices of various organs,
Pterocarpus
increases glycogen content of experimental subjects diaphragm
marsupium (Vijaysar)
in a dose-dependent manner.

exerts pancreatic cell


regranulation

(J. Clin. Biochem. Nutr., 40, 163173, 2007)

Pancreas

(-) Epicatechin, an active principle in


the extract of Pterocarpus
marsupium (Vijaysaar) increases the
cAMP content of the -islets which is
associated with the increased insulin
release, conversion of proinsulin to
insulin and cathepsin B activity. The
response of the -islets to the
(-)epicatechin stimulation is more
pronounced in immature (one month
old) than in mature (12 month old)
experimental subjects.

A multicentric trial was carried out to compare the blood glucose


lowering effect of Pterocarpus marsupium (Vijaysaar) with
pharmacological agent of sulphonyl urea group (Tolbutamide). A
total of 365 newly diagnosed or untreated patients with type 2
diabetes mellitus whose fasting blood glucose was< 12.8 mmol/ l
were randomized to receive either the trial drug or the standard
pharmacological agent for duration of 36 weeks with 4 weekly
clinic attendance for review and collection of drug. There were 172
patients in vijaysar treated group and 177 patients in the
tolbutamide group. 86% in Pterocarpus marsupium (Vijaysaar)
and 94% in tolbutamide group maintained glycaemic
control.Thus, it is concluded that vijaysar is effective in blood
glucose lowering effect with its hypoglycaemic effect being
comparable to that of tolbutamide in treatment of patients with
type 2 diabetes and it is free from any significant side effects.

(Indian J.Exp. biol. 29(6): 516-520, 1991)

(Diabetologica Croatica, 34-1, 2005)

Blood Glucose (mmol/l)

HbA1c (%)
Drug
Group

Baseline

Vijaysar
(n=45)

10.5

Tolbutamide
(n=45)

10.5

Parameter

At 36
weeks
8.9
8.7

Mean fall
(95%C.I)

Fasting

1.6*
1.8*

Postprandial

* P<0.001 C.I : Cofidence interval

Vijaysar
(Pterocarpus marsupium)

A rich source of
(-)epicatechin

Repairs
& Revives
-cells
of islets
of Pancreas

Increases
glucose
mediated
insulin
secretion

Increases
glucose
utilisation
in tissues

Drug
group

At
Baseline

At 36
weeks

Mean fall
(95%C.I)

Vijaysar
(n=172)

9.4

7.0

2.4

Tolbutamide
(n=177)

9.4

6.7

2.7

Vijaysar
(n=172)

13.9

9.6

4.3

Tolbutamide
(n=177)

13.8

9.4

4.4

Helps
Control
Diabetes
Mellitus

Research product of MINISTRY OF SCIENCE & TECHNOLOGY

Inhibits activity of -amylase & -glucosidase

Activates insulin receptor


substrate - associated,
phosphoinositide 3-kinase
activity
The administration of Trigonella
foenum-graecum (Methi) extract
significantly decreased plasma glucose,
insulin resistance and lipid parameters
i n b o t h p reve n t ive a n d c u ra t ive
studies.The effect on glycaemia in High fat
diet (HFD) experimental subjects can be
attributed to reduced insulin resistance
or altered glucose metabolism. This could
be related to modulation of insulin action,
or to extra-pancreatic effects, such as the
regulation of glucose uptake from the
intestinal lumen by the delay of
carbohydrate digestion or absorption.
A n a c t ive c o m p o u n d
4-hydroxyisoleucine stimulates glucosedependant insulin release in muscle and
liver by activating insulin receptor
substrate-associated phosphoinositide-3
kinase activities. Trigonella foenumgraecum (Methi) improved Diabetes by
promoting adipocyte differentiation and
inhibiting inflammation in adipose tissue,
possibly through diosgenin- related
decreased insulin resistance. In type 2 or
type 1 diabetic patients, fenugreek has
been shown to improve the control of
diabetes and reduce hypergly- cemia.
(J. Ethnopharmacol 142, 516-522, 2012)
Effects of TFG extract on Plasma Glucose

Weight
Plasma Glucose
Triglycerides

Blood Glucose
Concentration

200
150
100

(J biol. Agri. Healthcare 1(2), 50-55, 2011)

Reduces intestinal
absorption of glucose
Trigonella foenum-graecum (Methi) seeds
contain 45% to 60% carbohydrate
( ga l a c to m a n n a n ) , 6 % to 1 0 % l i p i d
(polyunsaturated fatty acids), and 20% to
30% protein (4-hydroxyisoleucine) being
one of the major amino acids.
Galactomannan, a polysaccharide polymer
that dissolves in water because of the
presence of galactose side chain, has been
reported to reduce postprandial blood glucose
response because of its viscous property and has
the potential to reduce intestinal absorption of low
concentrations of glucose and benefit in blood glucose
management.
(Nutrition res., 29, 49-54, 2009)

50

Trigonella foenum-graecum (Methi) seeds contain 55 % of


soluble fibre, this gel forming fibre absorbs water as it passes
through the gut and swells up, binding with the food. It delays
gastric emptying, slows down carbohydrate absorption and
delays glucose transport. Fenugreek seeds contain many
amino acids but the most abundant amino acid is
4-hydroxyisoleucine. This amino acid stimulates pancreas
to release insulin. Fenugreek seeds are
rich source of polysaccharide
Delays gastric
galactomannan and other bioactive
emptying,
constituents which have been
slows down
shown to lower blood sugar and
carbohydrate
prevent diabetes induced cataract.
It also lowers cholesterol and
absorption & delay
triglycerides.
glucose transport

STD
Control

HFD
Control

TFG
Treated

60
50
40
% Inhibition

Normalises Post Prandial Hyperglycemia (PPHG)

70

30
20
10
0
50

100

150
200
Concentration (g/ml)

250

Aqueous extract

Figure 1: Inhibitory activity of Trigonella


foenum-graecum extract against -amylase
60
50
% Inhibition

C.S.I.R.

Trigonella foenum-graecum (Methi) was


studied to establish the inhibitory activity
against -amylase and -glucosidase enzyme
activity. The percentage inhibition by each
extract is shown in Figure 1. Aqueous extract at
250 g/ml showed prominent -amylase
inhibitory potential. The percentage of
inhibition ranged from 43.95% to 9.23% in
case of aqueous extract. The -glucosidase
inhibitory activity of extract of T. foenumgraecum is shown in Figure 2. Aqueous extract
showed, percent -glucosidase inhibition in
dose dependent manner. Inhibition in enzyme
activity ranged from 33.64% to 7.32% in case
of aqueous extract.
Therefore, methi based -amylase and glucosidase inhibitors are likely to be useful in
regulating blood-glucose level. Inhibition of
these enzymes delays the digestion of
carbohydrates, causing reduction in the rate of
glucose absorption.
(Ayu 34(1)] 109-112, 2013)

40
30
20
10
0
50

100
150
200
Concentration (g/ml)

250

Aqueous extract

Figure 2 :Inhibitory activity of Trigonella


foenum-graecum extract against -glucosidase

Stimulates insulin release from -cells


Trigonella foenum-graecum (Methi) has been
observed to cause glucose induced
insulin release in-vitro and in-vivo.
4-hydroxyleucine, a novel amino acid
from fenugreek seeds, increases glucose
stimulated insulin release from isolated
-islet cells. The extracts, powder and
gum of Trigonella foenum-graceum
helps to improve insulin sensitivity
presumably due to presence of fibres,
which slows down the metabolism of
carbohydrates, resulting in reduced insulin
levels and lower blood glucose.
(Phytotherapy and diabetes 15, 5(2), 176-197, 2014)

Trigonella foenum-graecum (Methi)


seeds are rich in proteins, saponins and
fibres. The high fibre content is a potential
mechanism of beneficial effect in Diabetes
Mellitus patients. Mechanism of action
may include delayed gastric emptying,
slowed carbohydrate absorption and
inhibition of glucose transport by the
fibre content as well as increased
erythrocyte insulin receptors and
modulation of peripheral glucose
utilization.
(J Diabetes and Endocrinology 3(4), 44-56, 2012)

Research product of MINISTRY OF SCIENCE & TECHNOLOGY

Mitigates oxidative stress, promotes


insulin secretion

C.S.I.R.
Strengthens - cells functional capacity

Regeneration of -cells is possible with the treatment of


Gymnema sylvestre (Gudmar) extract mainly from acinar
cells. The acinar cells are proposed as precursors of ductal
cells in focal regions, which can differentiate into
-cells. The Histopathological results showed the
congestion with sever decrease in number of -islets of
langerhans and -cells in streptozotocin treated diabetics
(Fig-2). But in treated diabetic subjects it shows decrease
in congestion with mild decrease in islets and increase in
normal -cells (Fig- 3). This clearly indicates that there is a
reversal of the endocrine damage in Gymnema
sylvestre extract treated
experimental subjects.
(Digest J. Nanomaterials & bio structures,
7(1)135-142, 2012)

Regulate glucose
homeostasis
Decreases
gluconeogenesis
Increases glucokinase
& G-6PD activity
Decreases G-6P activity
Protects from oxidative
stress

In diabetes mellitus, high glucose levels inactivate antioxidant


enzymes SOD, CAT, GPx etc. By glycating these proteins,
hyperglycaemia induces oxidative stress which in turn causes lipid

Gymnemic acid is the main active constituent of Gymnema sylvestre possessing beneficial effects
in controlling blood glucose level by strengthening -cells.

peroxidation. Decreased enzyme activity and increased lipid


peroxidation , protein carbonylation in diabetic experimental
subjects was restored as an effect of Berberis aristata

Gymnema sylvestre
(Gurmar)

(Daruharidra) root extract, attenuating antioxidant status in

Promotes repairative
regeneration of islet cells.
Increases secretion of glucose
mediated insulin.
Causes delay of glucose
absorption from intestine.
Increases the utilization of
glucose as it increases the
activities of enzymes
responsible for utilization of
glucose by insulin-dependent
pathways.
Increases in phosphorylase
activity, decreases in
gluconeogenic enzymes and
Sorbitol dehydrogenase.

content in diabetic liver which plays an important role in the

(Der Pharmacia Lettre 2010, 2(1), 275-284)

Berberis aristata
(Daruharidra)

diabetic liver. Daruharidra extract restored reduced glutathione

(Anc. Sci. Life 31(4), 151-159,2012)

prevention of diabetic complications.


(J of Ethnopharmacol, 123; 22-26, 2009)

Tinospora cordifolia (Giloe) regulates the blood glucose through


mitigating oxidative stress , promoting insulin secretion and also
by inhibiting gluconeogenesis and glycogenolysis, thereby
regulating blood glucose. The isoquinoline alkaloid rich fraction
from stem exerts insulin mimicking and insulin releasing effect
in-vitro and in-vivo. Aq. extract has been reported to regulate blood
glucose levels, enhance insulin secretion and suppress oxidative
stress markers. The aq. extract has also been reported to decrease
the levels of Glycosylated haemoglobin and other reactive
substances.
(Anc. Sci. Life., 31(4): 151-159, 2012)

The steptozocin induced diabetics had a damage over pancreatic acinar region as can be seen by reduced
pancreatic amylase and lipases and these decreases are corrected by Gurmar therapy.

Fig. 1. Pancreatic section from normal


experimental subject. The islet of
L a n g e rh a n s s h ows we l l d e f i n e d
granulated dark beta cells.

Fig. 2. Diabetic experimental subject


pancreas, showing imperfections. The
islet is atrophied and hydropic changes
are seen.

(Digest J. Nanomaterials & bio structures, 7(1)135-142, 2012)

Fig. 3. Islet from a diabetic experimental


subject. after Gymnema sylvestre,
therapy. The beta cells appear dark, well
developed and granulated .

Alpha amylase and glucosidase are the


digestive enzymes. Their inhibitors are
considered to be effective for the
treatment of diabetes, obesity and
hyperlipidaemia. In alpha amylase assay
the positive control acarbose showed IC50
47.981.2 and extract of Rubia cordifolia
(Majeeth) showed an IC50 95.341.6.
Maximum percent inhibition of
R.cordifolia extract and Positive control
acarbose was found to be 50% and 69%
at a concentration of 98.331.54 g and
96.672.89 g respectively.
(IJPAES, 3(3), 42-49, 2013)

Groups time
Evaluation
st

SGPT
BGR-34

Placebo
SGOT

p value
Hb

I week
line)
Group(base
1 (NC)

204.6833.4
31.82+5.18
BGR-34

194.5612
27.51+2.16

13.4+1.59
0.42

th
IV Week
Group
2 (NE)

203.3512.6
30.20+6.29
BGR-34

192.3114
28.55+3.12

14.1+2.26
0.48

th
VIII week
Group
3 (DC)

200.1528.4
65.78+7.29
BGR-34

191.0018
61.56+3.41

12.5+1.82
0.36

th
XII week
Group
4 (DE)

197.6216.4
48.58+4.29
BGR-34

190.1822
39.69+2.89

13.3+1.72
0.41

th
XVI week
Group
5 (DG)

192.3923.8
45.34+3.69
BGR-34

188.2424
45.44+5.01

12.9+1.79
0.51

Values are given as mean S.D for five determinations in each group.
NC: Normal control, NE: Normal rats administered Rubia cordifolia ,
DC: Diabetic control, DE: diabetic experimental rats administered
Rubia cordifolia, DG: Diabetic rats administered glybenclamide

Research product of MINISTRY OF SCIENCE & TECHNOLOGY


CLINICAL STUDY
Placebo

A double blind placebo controlled clinical trial of BGR-34 in


patients with mild to moderate diabetes mellitus was carried
out with prior approval from the ethical committee at
Aggarwal Hospital, New Delhi. 100 patients from the OPD at
Aggarwal Hospital were screened, out of which 48 patients
were selected after applying inclusion and exclusion criteria.
The clinical trial was conducted for period of 16 weeks.

C.S.I.R.

Formulation optimization study


BGR-34 formulation Optimization for best
Anti-hyperglycaemic activity

Primary screening of anti-diabetic potential of the herbal combinations in different proportions was
undertaken by conducting Oral Glucose Tolerance Test (OGTT) as per the selected parameters. The treatment
groups were dosed orally at 2000mg/kg body weight, 30 min. before giving glucose solution. Group 1 of
experimental subjects was treated as normal control, and given only glucose solution orally. Group 2 referred
as positive control, was treated with Metformin at 250 mg/kg body weight. Group 3-9 were given different
combinations of herbs. The blood glucose level at intervals of 15, 30, 60 and 90 min were recorded after giving
glucose solution successively. Based on the glucose metabolism kinetics of combinations, BGR-34 was found
to have most optimum composition with best of anti-hyperglycemic activity.

BGR-34 maintained the glucose levels


significantly when compared to control.
Glucose metabolism kinetics
of extract combinations

"

BGR-34, delays in
absorption of
glucose from GIT,
Inhibits Advanced
glycation
end products (AGEs)
accumulation,
enhances insulin
release & increases
conversion of
pro insulin to
insulin.

"

Glucose (mg/dL)

275

Vehicle
Metformin
I

225

(2:2:0)

48 patients (30 male and 18 females) with type 2 diabetes


mellitus were evaluated in the study. There were 24 patients
in the BGR-34 group (drug arm) and 24 patients in the
placebo group (placebo arm).The mean ages of patients for
BGR-34 and placebo group were 46.209.2 and 48.408.6
years respectively. Average weight in BGR-34 group was
64.68.2 kg and in placebo group it was 66.29.4 kg.
Biochemical results of all patients were analyzed after
completion of the study. Statistical analysis was carried out
to calculate effect of BGR-34 on fasting blood glucose and
post prandial blood glucose. Highly significant results were
observed in 15 (62.5%) patients in the drug arm. Blood sugar
fasting showed significant reduction in BGR-34 treated
group as compared to placebo group.

BGR-34

150148146144142140138136134132-

FBS 1

FBS 16

Fig 1: Comparison between means of blood glucose


values in drug and placebo arms before and after the
treatment

210205200195-

II (2:1:0)
III (2:0:1)

175

IV (2:0:2)

125

V (2:0:5:0:5)
VI (2:0:0)

75
0

15

30

45

60

75

90

VII (2:1:1)

105

25

Time Interval (minutes)

Conclusion:

Blood Glucose levels (Time Interval in minutes)


Groups
0

15

30

60

90

Group-1 Vehicle

899.03
BGR-34

20220.85
BGR-34

215.714.65
BGR-34

1319.97
BGR-34

85.53.41
BGR-34

Group-2 Metformin

92.44.92
BGR-34

151.310.41
BGR-34

138.85.90**
BGR-34

109.15.88
BGR-34

80.64.67
BGR-34

Group-3 I (2:2:0)

70.28.03
BGR-34

161.629.53
BGR-34

11724.74***
BGR-34

52.69.34***
BGR-34

65.14.07
BGR-34

Group-4 II (2:1:0)

80.85.32
BGR-34

145.236.35
BGR-34

128.67.88***
BGR-34

89.47.10***
BGR-34

75.33.70
BGR-34

Group-5 III (2:0:1)

47.53.03
BGR-34

147.413.89
BGR-34

126.610.21***
BGR-34

76.610.46***
BGR-34

71.64.80
BGR-34

Group-6 IV (2:0:2)

56.86.10
BGR-34

148.817.94
BGR-34

123.615.15***
BGR-34

773.18***
BGR-34

59.751.65
BGR-34

Group-7 V (2:0.5:0.5)
NBRMAP-DB

56.52.67
BGR-34

183.616.70
BGR-34

135.64.82***
BGR-34

665.68***
BGR-34

58.61.40
BGR-34

Group-8 VI (2:0:0)

46.36.59
BGR-34

115.7510.59
BGR-34
104.2512.65***
BGR-34

60.53.48***
BGR-34

63.253.09
BGR-34

Group-9 VII (2:1:1)

86.45.18
BGR-34

90.36.20**
BGR-34

625.41
BGR-34

138.26.91
BGR-34

117.75.91***
BGR-34

Glycosylated haemoglobin decreased from 7.890.12 to


7.010.18 which was found to be the significant decline in the
BGR-34 group. On the other hand in the placebo group, contrary
to this there was no decline in the glycosylated haemoglobin
level, instead of that an increase was reported from 7.900.14 to
8.010.22 during the 16 week study period. Favorable response
in lipid profile was seen in the patient on BGR-34.

**p<0.01, ***p<0.001 Vehicle vs treatment ; Metformin at 250mg/kg bd.wt.and combination


treatments at 500mg/kg body wt; administered 30 min prior to d-Glucose at 2000mg/kg

BGR-34 showed very promising results with respect to


glycemic parameters in patients with type 2 diabetes
mellitus. There was a significant improvement in the
feeling of well being due to better control of
hyperglycemia. The various mechanisms through which
the drug showed these results may be attributed to delay
in absorption of glucose from GIT, Inhibition of Advanced
glycation end products (AGEs) accumulation and
enhancing insulin release and conversion of pro insulin
to insulin. It is further suggested that BGR-34 should be
further extensively used as a mono therapy/adjunctive
therapy for the regulation/ control of blood glucose level.

190185PPBS 1
PPBS 16
180- Fig 2: Comparison between means of Post Prandial Blood
Sugar (PPBS) mg % values in drug and placebo arms
before and after the treatment

8.07.87.67.47.27.0HbA1c 1
6.8-

HbA1c 16

Fig 3: Comparison between means of Glycosylated


Haemoglobin (HbA1c) values in drug and placebo arms
before and after the treatment

Study on Bio-chemical parameters

BGR-34 prevents disturbances in


the bio-chemical parameters due to diabetes
C.S.I.R.
Study on Anti-oxidant Activity

Provides pronounced Antioxidant activity


The Antioxidant protective DPPH radical scavenging activity
activity of BGR-34 was
DPPH radical scavenging
ability (IC , g/ml)
determined using DPPH radical Sample Name
scavenging ability (IC50, g/ml)
84.02 2.23
BGR-34
BGR-34
model. BGR-34 showed strong
anti-oxidant activity, as high as 9
09.36 1.20
Ascorbic Acid
times as compared to Ascorbic
acid the standard anti-oxidant.
50

BGR-34 showed nine times higher anti-oxidant


activity than that of standard anti-oxidant Ascorbic acid.

The bio-chemical parameters in


diabetic experimental subjects
receiving BGR-34 as well, remain
significantly different from the
diabetic control with p<0.001 in
Serum alkaline phosphatase (ALP)
and serum creatinine and P<0.05 in
Total cholesterol over the study
period after induction of diabetes.
Effect of BGR-34 on Biochemical parameters
Groups

ALP (IU/L)

200 ***

150 -

***

100 50 0Vehicle

Metformin

BGR-34

Streptozotocin

(NBRMAP-DB-II)

Anti-hyperglycemic activity Study

BGR-34 maintains glucose homeostasis in Diabetics


Anti-hyperglycaemic potential of BGR-34 was studied in streptozotocin induced diabetic
experimental subjects with fasting blood glucose (FBG) observed on 0,2nd, 10th & 21st
day. BGR-34 was found to Effect of BGR-34 on Blood glucose level
significantly maintain in normal & STZ induced Diabetics
glucose homeost a sis
Groups
0 day
Post induction
10th day
21st day
quite comparable to that
Group 1
104BGR-34
4.92
87.1 4.37
90.6 6.73
75.1 2.75
(Normal Control)
with normal control
Group 2
BGR-34
7.16 327.3 13.41
172.3 8.36*** 80.16 2.79***
( Ve h i c l e g ro u p ) a n d (Metformin) (+ve control) 103.3
Metformin treated group
Group 3 (BGR-34)
85.3
BGR-34
2.67
350.6 17.34
175.5 2.83*** 71.5 3.41***
and significantly different
Group 4 (STZ treated)
99.6
BGR-34
4.05
357.4 14.9#
398.6 21.0
293.6 8.31
(-ve control)
as compared to negative
The values are expressed as mean SEM. n = 6 experimental subjects per group. Significant difference of
diabetic control from normal control on consecutive days: #P < 0.001. Significant difference of treated groups
control streptozotocin
from diabetic control on the corresponding days: * P < 0.05, ** P < 0.01, *** P < 0.001
only treated group with

Serum Creatinine (mg/dl)


0.7-0.60.50.40.30.20.10-

***
***

Vehicle

Metformin

BGR-34

Streptozotocin

(NBRMAP-DB-II)

Total Cholesterol (mg/dl)


60 -

#
*

50 -

40 30 20 10 0-

Vehicle

Metformin

BGR-34
(NBRMAP-DB-II)

Streptozotocin

Group1

Bio-chemical
Parameters

Vehicle
BGR-34

Group 2

Metformin

Group 3

BGR-34
(NBRMAP-DB-II )

Group 4

Streptozocin

ALP(IU/L)

52.61
BGR-34
3.24

Creatinine (mg/dl)

0.36
BGR-34
0.02

0.29 0.03

0.40 0.03***

0.69 0.02#

TC (mg/dl)

33.46
BGR-34
2.80

39.59 2.28*

37.18 1.42*

51.15 4.6#

140.29 4.71*** 143.41 2.12*** 177.85 3.54#

The values are expressed as mean SEM. n = 6 experimental subjects per group. Significant
difference of diabetic control from normal control on consecutive days: #P < 0.001. Significant
difference of treated groups from diabetic control on the corresponding days: * P < 0.05,
** P < 0.01, *** P < 0.001

"

Study on various Biochemical


parameters of treated groups
suggest the efficacy & safety
of the formulation, BGR-34
in terms of Liver
functions, Kidney
functions and lipid profile
& general behaviour
of experimental
subjects.

"

Rubia cordifolia

2. Berbamine
3. Palmatine

{ Blood glucose regulator

4. Dehydrocheilanthifoline- Insulin secretagogues


5. 8- oxo berberine -Regulates glucose homeostasis
6. Columbamine 7. Jatrorrhizine-

Insulin secretagogues

8. Rubiadin - Potentiates insulin effect due to


increased peripheral utilization of glucose.
9. Purpurin -

{ Strong anti-oxidant action


11. Manjistin Immuno potentiating effect
12.Pseudopurin -{
10. Xanthopurin -

14. Galactomannan -Regulates glucose homeostasis


and exerts diabetes induced cataract.
15. - tocopherol - Reduces level of glycosylated haemoglobin.
16. Fenugreekine -Maintains blood glucose by slowing down metabolism
17.Scopoletin 18. Trigonelline -

Blood glucose regulator

27. Palmatine 28. Jatrorrhizine -

Insulin mimicking effect

29. Magnoflorine - -Insulin releasing effect

30. Gymnemic acid -Modulates incretin activity &


regeneration of pancreatic cells and delays
glucose absorption in blood.
31. Gurmarin - Incretin mimicking action, delays absorption of
glucose and interferes with ability of taste buds to
differentiate between bitter and sweet.
32. Gymnemagenin - Maintains blood glucose homeostasis
and anti-oxidant action.
33. Dihydroxy gymnemic triacetate -Insulin secretagogues
34. Isoquinoline - Insulin secretagogues

Gymnema sylvestre

13. 4 hydroxy isoleucine -Insulinotropic Activity

Tinospora cordifolia

Trigonella foenum graecum

1. Berberine - Potent DPP4 inhibitor

19. Pterostillbene -Exerts regranulation of


pancreatic cells.
20. Marsupin 21. Pterosupin Insulinogenic
22. Liquirtigenin23. Epicatechin- -converts pro insulin to insulin.
24. QuercitinBlood glucose regulator
25. Myrcetin26. Isoliquirtigenin-Anti-hyperglycaemic

Pterocarpus marsupium

Berberis aristata

C.S.I.R.

A scientifically proven, optimized formulation


with 34 vital phytoconstituent derivatives

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