DBC-24 is a new researched product from TULIP LAB.
Clinical Trail has established good efficacy and safety of the product in lowering blood glucose levels and reducing insulin resistance with regular usage.
The product is devoid of side effects of Chemical based Drugs.
The product is also effective in management of Irregular menstrual cycle on account of Cyst formation in Ovaries
( Poly Cystic Ovarian Syndrome- PCOS )
International level clinical trail has been registered on WHO PORTAL : See the link in the slides
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Diabetese- One reason not to Worry ! A new Clinically researched NATURAL PRODUCT is here: DBC-24
1.
2. Clinically Approved & Safe Anti-Diabetic product
Years of Scientific Research
Months of Pre-clinical Studies
Months of Clinical Studies
Approval of Clinical Data & Recognition by
various MOH’s
Devoid of Chemicals
but full with
‘Natural Synergy’
Highlights:
• Enhances islet cells regeneration activity
• Reduction of Blood sugar level
• Reducing Insulin resistance.
• Perfect adjuvant with OHA’s
3. DBC-24 is ‘Natural’ & ‘non synthetic’ answer on: HOW to effectively
manage blood glucose level ?
DBC-24’s patented combination of herbs is proven to be very effective for
diabetic patients.
Benefits : Comparable to Chemical based Drugs
Helps control, monitor & normalize
blood sugar level
Helps Manage TYPE II Diabetes
Helps manage
Polycystic Ovarian
Syndrome (PCOS)
Increase Glucose Utilization& inhibits
glucose absorption
Effectively controls Insulin Resistance
4. Result of Synergy
(Within 90 days):
13.3% reduction in mean
fasting blood sugar level .
Mean postprandial blood
sugar level reduced from
baseline value to 12.87%.
Mean serum insulin level
reduced from baseline
value to 10.2%.
5. Gymnema sylvestre
Regulates the blood sugar level of the body and increases the
secretion of insulin. This herb possesses anti-diabetic property.
Gymnema sylvestre also promotes the regeneration of islet cells.
Enicostemma littorale
Possesses antioxidant property and enhances glucose induced
insulin release. This herb also maintains the blood glucose levels.
Pterocarpus marcupium
Possesses hypoglycaemic property. It helps in the production of
more insulin and conversion of pro insulin to insulin.
DBC 24: Mechanism Of Action
6. Syzygium cumminii
Helps in the regeneration of pancreatic Beta (β)cells
Significantly decreases the blood glucose as well as
triglyceridemic levels
Emblica officinalis
7. Restore the body's ability to control blood
sugar levels by boosting the effectiveness of
the body's own insulin.
Improvement in glucose tolerance and
diminished insulin requirements.
Enhances islet cells regeneration activity.
Checks glucose absorption from intestine
and inhibits alpha-glycosidase.
Increases utilization of glucose by increasing
the activities of enzymes responsible for
utilization of glucose by insulin-dependant
pathways
Natures Energy works in Synergy
DBC 24 :Improves response to conventional Oral Hypoglycemic Agents (OHAs)
and eventually helps reduce intake of OHA's.
9. Inclusion criteria:
1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on
mono / poly-drug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea
and Biguanids) for at least last 3 months.
2. Subjects having HbA1C value between 7-10% (both inclusive) at screening.
3. Subjects having Fasting Plasma Glucose 126-252 mg/dl (both inclusive) at screening.
4. Subjects of male gender or a non pregnant, non lactating females, at least six weeks
postpartum. A urine pregnancy test is required for all female subjects unless subject has had a
hysterectomy, tubal ligation, or is > 2 years postmenopausal.
5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2.
6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an
informed consent form.
Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to
evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy
with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients.
109 patients suffering from type II diabetes mellitus
10. 1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides.
2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2.
3. Subjects having known hepatic or renal disease.
4. Subjects having an active malignancy.
5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy,
Retinopathy, and Diabetic wounds.
7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or
HIV.
8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption,
metabolism, or excretion, excluding diabetes.
9. Use of any other investigational drug within 1 month prior to randomization
10. Known hypersensitivity to ingredients used in study drug
11. Pregnant and Lactating females.
Exclusion criteria:
11. Dosage and Duration of Treatment:
Two tablets twice daily orally before meals as an add on therapy to oral
hypoglycaemic agent(s) for three months(90 Days)
Primary Outcome(s)
1) Changes in Fasting and
Postprandial Plasma Glucose
levels .
2) Changes in HbA1C% Value
Secondary Outcome(s)
1) Changes in fasting Serum insulin level
2) Reduction in dose of OHAs
3) Improvement in clinical symptoms of Type 2 DM
4) Global assessment for overall improvement by the
subject
5) Global assessment for overall improvement by the
investigator
6.) Tolerability of study drugs assessment by study
subject and investigator
7) Laboratory parameters like Liver function tests
(LFT), renal function tests (RFT), Lipid Profile, C
complete blood count (CBC), ESR, Hb% and Urine
Examination
Time point: Day 0, Day 30, Day 60 and Day 90
12. In all recruited subjects
• 62 subjects completed the study (33 subjects were in Group A and 29
subjects were in group B).
• 23 subjects dropped out prematurely (10 in group A and 13 in group B)
Details of Clinical Trial
PATIENTS WERE RANDOMISED & DIVIDED IN 2
GROUPS
GROUP A : METFORMIN + DBC
GROUP B : METFORMIN + PLACEBO
13. Effect of Trial Drugs on Mean Fasting Blood Sugar Level
149.82 147.56
158.83
135.14
164.52
142.64
159.98
144.79
0
20
40
60
80
100
120
140
160
180
Day 0 Day 30 Day 60 Day 90
Treatment Duration in Days
MeanFastingBloodSugarValue(mg/dl)
Group A
Group B
Graph 1: Effect of trial drugs on Fasting Blood Sugar Level:
At the end of treatment, there was 13.3% reduction in mean fasting blood
sugar level among Group A that was statistically significant.
Among Group B, there was 9.5% fall in mean fasting blood sugar level that
was statistically insignificant.
Group A: Metformin+ DBC
Group B : Metformin + Placebo
14. Effect of trial drugs on mean glycosylated hemoglobin (HbA1c %)
Effect of Trial Drugs on Mean Glycosylated Hemoglobin %
8.94
8.16
8.49
7.98
7.4
7.6
7.8
8
8.2
8.4
8.6
8.8
9
9.2
Day 0 Day 90
Treatment Duration in Days
MeanGlycosylatedHemoglobin%
Group A
Group B
At the end of treatment, 8.7% reduction from baseline value in mean Glycosylated
Hemoglobin was observed in subjects of Group A,
6.0% reduction from baseline in mean glycosylated hemoglobin was observed in
subjects of group B.
On evaluation fall in mean glycosylated hemoglobin was more in group A than group B.
Group A: Metformin+ DBC
Group B : Metformin + Placebo
15. Effect of trial drugs on mean serum insulin level:
Effect of Trial Drugs on Mean Serum Insulin Level
7.72
10.24
8.6
8.18
0
2
4
6
8
10
12
Day 0 Day 90
Treatment Duration in Days
MeanSerumInsulinLevel
Group A
Group B
At the end of treatment, there was 10.2% reduction in mean serum insulin among
subjects of Group A, which was statistically insignificant.
There was 25.2% increase in mean serum insulin level
from baseline value to the end of study value among
subjects of group B, which was statistically significant.
Group A: Metformin+ DBC
Group B : Metformin + Placebo
16. At the end of the study, there was 13.3% reduction (statistically significant) in the mean
fasting blood sugar level among subjects of group A (DBC GROUP) , where as 9.5%
reduction (statistically insignificant) in the mean fasting blood sugar was observed among
subjects of group B(NON DBC).
DBC scored over placebo as an adjuvant to OHAs in the management of fasting blood sugar
in type II diabetic subjects. At the end of the treatment, 12.87% (statistically significant) fall
was observed in mean postprandial blood sugar level among the subjects of Group A (DBC),
where as 0.59% rise was observed in mean postprandial blood sugar level among subjects
of group (NON DBC) .
This indicates that OHAs along with placebo failed to
control postprandial blood sugar levels in type II diabetic
subjects, where as drug DBC proved to be effective as an
adjuvant to OHAs in the management of postprandial
blood sugar levels in type II diabetic population.
Approximately 50 other Laboratory & Clinical parameters were evaluated…
What is important………. ??
17. Important Fact…cannot be ignored
In both the groups, no change in dosages of background OHAs was made during
the entire study period by the investigator
At the end of the trial, 8.7% reduction was observed in the mean glycosylated
hemoglobin percentage among subjects of group A, whereas 6% reduction in the mean
glycosylated hemoglobin was observed among subjects of group B.
We all agree : Glaciated hemoglobin (HbA1c) concentration is an indicator of average
blood glucose concentration over three months and has been suggested as a tool in
screening of diabetes as well as monitoring control of blood sugar levels in the
management of diabetes.
DBC 24 proved to be superior over placebo as an
adjuvant to OHAs for better control over glaciated
hemoglobin%.
18. Did you pay attention ?
In the present study, 10.2% reduction in the mean serum insulin
level was observed among subjects of Group A (DBC Group) as
compared to 25.2% increase in the mean serum insulin level among
subjects of group B (NON DBC GROUP).
This indicates that DBC 24 as an adjuvant to OHAs was
probably able decrease insulin resistance / sensitize insulin
receptors to utilize insulin available in the body to control
blood sugar levels, where as placebo failed to decrease
insulin resistance.
19. Both the groups were effectively able to
reduce symptoms of diabetes such polyurea,
polyphasia, polydypsia and fatigue.
At the end of the study, according to
physician’s and patient’s assessment for
overall efficacy, good to excellent overall
efficacy was observed in 72.7% subjects of
group A(DBC+ Metformin), whereas good to
excellent overall efficacy was observed in
55.2% subjects of group B(Only Metformin).
DBC-24 was able to sensitize insulin receptors.
Natural synergy makes DBC Different
20. It has been observed that defective insulin secretion and insulin resistance
are the two main factors causing the development and progression of type
2 diabetes.
• After an initial improvement, glycemic control continues to deteriorate
despite the use of oral hypoglycemic agents aimed to enhance insulin
secretion and to reduce insulin resistance.
• This deterioration can be attributed to the progressive decline of β-cell
function, and insulin treatment is usually required in type 2 diabetic pa-
tients who are not able to obtain good glycemic control with oral
hypoglycemic agents.
“Although new treatment options for type 2 diabetic patients are
increasingly available, agreement on the most effective treatment approach
for individual patients has not been achieved”.
In the UK Prospective Diabetes Study*:
21. The present study provides the evidence in support of the potential efficacy and
safety of the herbal formulation ‘DBC 24’ as an adjuvant to OHAs in the
management of type II diabetes mellitus.
DBC 24 as add on therapy helps to reduce insulin resistance/sensitize insulin
receptors in subjects having poor response to OHAs.
Hence it can be concluded that DBC 24 can be used as
add on therapy to OHAs to avoid insulin resistance/
failure of glycemic control, which usually happens
after prolong use of OHAs.
Natural synergy makes DBC Different
22. PCOS occurs in 5% to 10% of women and is the
most common cause of infertility in women.
Irregular menstrual Cycle
Weight Gain
Acne & growth of
facial hair
multiple, small cysts
in the ovaries.
Elevated insulin
levels and insulin
resistance.
skin discolorations.
Dandruff.
high cholesterol
levels.
elevated blood
pressure.
Any of the above symptoms and signs may be absent in PCOS, with the exception of irregular
or no menstrual periods. All women with PCOS will have irregular or no menstrual periods .
23. Malfunction of the body's blood sugar control system (insulin system) is
frequent in women with PCOS, who often have insulin resistance and elevated
blood insulin levels, and researchers believe that these abnormalities may be
related to the development of PCOS.
It is also known that the ovaries of women with PCOS produce excess amounts
of male hormones known as androgens. This excessive production of male
hormones may be a result of or related to the abnormalities in insulin
production.
Evidence Based Science:
24. Hyperandrogenic anovulation (PCOS): A unique disorder of insulin action
associated with an increased risk of non-insulin-dependent diabetes mellitus
American Journal of Medicine,
Volume 98, Issue 1, Supplement 1, Pages S33–S39, January 16, 1995
“Evidence suggests that women with polycystic ovary syndrome have a unique disorder of
insulin action and are at increased risk to develop non-insulin-dependent diabetes
mellitus. Further, non-insulin-dependent diabetes mellitus in women with polycystic ovary
syndrome has a substantially earlier age of onset (third to fourth decades) than it does in
the general population (sixth to seventh decades)”.
“Women with PCOS have profound peripheral insulin resistance, independent of
obesity, due to a post-binding defect in insulin signalling ”.
The evidence is growing :
25. Therapeutic rationale (For PCOS):
Polycystic Ovarian Syndrome (PCOS) affects 6-10 % of women population and it is very often
associated with insulin resistance.
PCOS leads to amneorrhoea, anovulation, oligomenorrhoea, hirsutism etc.
DBC-24 is a researched HERBAL formulation marketed by TULIP LAB.
It is indicated in PCOS for improving insulin sensitivity, thereby promoting ovulation and
reduced levels of testosterone.
DBC helps in controlling hirsutism, acne, alopecia and obesity.
Treatment Protocol
DBC-24 works very well for women with insulin-resistance. 1-2 tablets twice a day, half an
hour before meals decreases gastrointestinal absorption of glucose from the meals, regulates
the insulin response of the pancreas and increases peripheral utilization of glucose. A
treatment protocol with DBC-24 lasting for 3-4 months restores normal ovulation in a large
percentage of women.
With DBC-24: Get the ‘NATURAL SYNERGY’ for effective management
& Treatment of PCOS:
26. Advantages of taking DBC-24 over Metformin:
DBC-24 has no side effects where as patients
taking metformin have complaints of side
effects like gastrointestinal problems namely
nausea, vomiting, abdominal pain, loss of
appetite and diarrhoea.
DBC-24 helps in weight loss and helps the
patients suffering from obesity but metformin
does not help curing obesity in any way.
Metformin is expensive than most of the
sulfonylurea’s available where as DBC-24 is
cost effective and is not expensive.
Long-term use of metformin has been
associated with increased homocysteine levels
and malabsorption of vitamin B12. Higher
doses and prolonged use are associated with
increased incidence of B12 deficiency.
DBC-24 in PCOS improves
ovulatory function and several
metabolic derangements
associated with insulin resistance.
DBC-24 decreases the insulin
resistance and thereby corrects
the three axes namely metabolic,
reproductive and steroidogenic.
27. DBC-24 provides a sense of well-being and feeling
of less tired and less fatigue where as patients
taking metformin takes some time adjusting to the
medicine.
DBC-24 being the herbal medicine helps the
patient in curing diabetes and PCOS in a longer
run without any side effects.
DBC-24 does not show any signs of clinical
hypoglycemia unlike sulfonylureas.
DBC-24 is safe and effective insulin sensitizer for
the treatment of PCOS.
Lowers the lipid levels & protects against
cardiovascular diseases.
Cost effective for long-term use.
Improves quality of life and restores libido.
DBC 24 : A Better Choice
28. INDICATIONS:
As an add-on therapy in the management of Type 2 Diabetes mellitus, poorly
responding to OHAs,
Newly diagnosed mild to moderate Type 2 Diabetes mellitus, Impaired Glucose
Tolerance (IGT).
As a preventive medicine against the complications of Diabetes mellitus.
For management of Polycystic Ovarian syndrome(PCOS)
Dosage:
2 Tablets to be taken Twice a day just before taking meals.
Long term dosage has been found safe with good tolerance.
Cost effective & Devoid of side effects of CHEMICAL based
medicines.
60 Tablets in a Bottle: 15 days course in 1 bottle
29. Why ???
DBC provides round the clock ( 24 Hrs. ) protection against
diabetes & controls Insulin Resistance
30. For Out Licensing/Contract manufacturing Queries connect with-
Mr. Vishal Chandra, General Manager International Business.
E-mail: vishalvns04@yahoo.co.in, vishal@tlplindia.com
Skype: vishalukraine
Tulip Lab Private Ltd.