-
Research
Findings
CLINICAL TRIAL REPORT OF
DIABETGUARD GRANULES
DIABETGUARD GRANULES, a
formulation (formulated by GOODCARE
PHARMA PVT. LTD.) based on Ayurvedic principles is being exhaustively researched
for its effect on blood sugar levels and also its
potential
in adverting long-term complications of diabetes mellitus.
Its main ingredients
are
Eugenia
jambolana, Momordica charanctia, Gymmnema sylvestrae,
Tinospora cordifolia, Accacia catechu, Azadirecta indica and Silajit
etc.
Dosage: Granules : 1
spoonful with water before lunch and dinner
Capsules : Three capsules daily with water
before lunch and dinner.
Name of the
Latin
Name
Parts Used Quantity
Ingredients
Gurmar Gymmnema sylvetris
Leaf Powder
20 gm
Neem
Azadiracta indica
Leaf Powder
5 gm
Jamun Eugenia
jambolana
Seed Powder 10 gm
Karela
Momordica charanctia
Fruit Powder
5 gm
Giloy
Tinospora cordifolia
Stem powder 12 gm
khair Accacia catechu
Powder 5 gm
Haldi Curcuma longa Rhizome Powder
6 gm
Amla Phyllanthus emblica Fruit Powder 5 gm
Vijaysar Pterocarpus marsupium Wood Powder 5 gm
Tejpatta Cinnamomum tamala Leaf Powder 5 gm
Gular Ficus glomirata Leaf Powder 6 gm
Kutki Pichorrhiza krurra Wood Powder 5 gm
Methi Trigonella foenum-graeccum. Seed Powder 3 gm
Purified
Shilajeet Rock Derivative 4 gm
Powderang
Bhasma Powder 1 gm
Yasad
Bhasma Powder 1 gm
Processed
in Gurmar & Neam Leaf aquous extract.
Mode of action:-
It delayed the
rate of absorption of carbohydrates in gastro intestinal transit. It
also increases the uptake of glucose by cells. It is now established
that the herbal medicines have potency to increase the production of
insulin, and rejuvenates the liver and pancreas.
Gurmar(Gymnema Sylvetris):-
An enzyme isolated from it has been shown
to bring
about glycolysis
in vitro,reducing the strength of
a glucose solution. It
is believed to neutralize excess sugar present in the body in
diabetes mellitus. The
leaf extract contains gymnemic acid, which is said to inhibit the
adrenohyophyseal stress response and the hyperglycaemic response to
adrenaline and growth hormone. It has also been
shown to
have a regenerative effect on beta-cells.
*Principal Investigator
** Co-Investigator
TI:
Antidiabetic effect of a leaf extract from Jymnema sylvestris in
non-insulin-dependent diabetes mellitus patients.
AU:Baskaran,-K.;Ahamath,-B.K.;Shanmugasundaram,-K.R.;
hanmugasundaram,-E.R.B.
SO:
J-Ethno-Pharmacol. Limerick: Elsevier Scientific Publishers.
Oct 1990. v. 30 (3) p. 295-305.
TI:
Use of Gymnema
sylvestre leaf extract in the control of blood
glucose in
insulin- dependent diabetes
mellitus.
AU:
Shanmugasundaram,- E.R.B.; Rajeswari,-G.; Baskaran,-K.; Kumar,-B.R.R.;
Shanmugasundaram,-K.R.;
Ahmath,-B.K.
SO:
J-Ethno-Pharmacol. Limerick: Elsevier Scientific Publishers.
Oct 1990. v. 30 (3) p- 281-294.
TI:
Possible regeneration of the islets of Langerhans in
streptozotocin-diabetic rats given Gymnema sylvestre leaf extracts.
AU:
Shanmugasundaram,-E.R.B.; Gopinath,-K.L.; Shanmugasundaram,-K.R.;
Rajendran,-V.M.
SO:J-Ethno-Pharmacol. Limerick: Elsevier Scientific Publishers.
Oct 1990. v. 30 (3) p.-265-279
Neem
Leaf (Azadirachta indica):- Aqueous extract of leaves the blood
sugar level.Murty, K.S.et.el. :
Indian Journal of Pharmacol 10: 247 (1978).
Pillai
N.R. and G. Santakumari : Ind. J. Med. Research 74 : 931 (1981)
Jamun
Seed (Eugenia jambolana):-
The
seed extract
quickly reduces
blood sugar, liver glycogen,blood urea,serum cholesterol and
triglycerides.
Fifth dimensions November, 1989 to
January, 1990 Vol 12 (02) Page 11-13.
Karela (Momordica charantia):-
The
fruits and seeds yield a polypeptide considered
to be
similar to bovine insulin,which has been shown to have a
hypoglycaemic effect in all types of diabetes. It also promotes
peripheral utilisation of glucose.
AB:
The hypoglycaemic effect of orally administered extracts of
Momordica charantia L. fruits was
examined in normoglycaemic or cyproheptadine-induced hyperglycaemic
mice. The aqueous
extract reduced the fasting glucose levels of hyperglycaemic or
normoglycaemic mice. However, the ethanol extract did not affect the
fasting or non fasting glucose levels significantly in both groups
of mice. There was no significant difference between the
glucose-loaded and glucose-loaded plus aqueous extract given group.
On the other hand, oral glucose loading of the cyproheptadine-induced
hyperglycaemic animals reduced the fasting glucose levels
significantly. These results showed that aqueous extract of
M.charantia fruits has a hypoglycaemic activity without improving
the tolerance to glucose in cyproheptadine-induced diabetic mice.
TI:
Effect of
Karela (M. Charantia) on the glucose and insulin
response in
diabetic subjects.
SO:
Int-j-food-sci-nutr. Basingstoke,
UK: Scientific and Medical Division, Macmillan Press, 1992-. Oct
1993. v. 44 (3) p. 191-196.
AU:
Srivastava,-Y.; Venkatakrishna-Bhatt,-H.; Verma,-Y.; Venkaiah,-K.;
Raval,H.
TI:Studies on hypoglycemic effects of fruit pulp, seed, and
whole plant of Momordica charantia on normal and diabetic model
rats.
SO:
Planta-med. Stuttgart: Georg Thieme Verlag,. Oct 1993. v. 59 (5) p.
408-412.
Puified
Shilajit (Ashphaltam)
It has anabolic panceatotopic effects. It is valuable in the
cases of diabetic albuminuia where both casts and albumin diminish
and is to be said to be a cure for diabetic amauosis .It rapidly
relieves thirsts, polyuria, burning sensation and exhaustion and
markedly helps assimilation of sugar. It has been considered to act
as a biocatalyst
as it increases the peripheral demand of glucose for the growth and metabolic process. Thus by inhibiting the hyperglycaemia
it seems to save the beta-cells and pancreas from detoriating by
restricting glucose load and also by promoting unrestricted
endogenous insulin action.
The
Indian Materia Medica, p.- 23-32, K. M. Nadkarni.Chopra’s Indigenous Drugs of India, p.-437-438.
Vang Bhasma:
Age old Ayurvedic preparation is found
to be much effective in hyperglycaemia. This has been used in diabetes mellitus for
centuries.
Meteria
Medica of India, Nadkarni. Bhav Prakash p. Ayurvedic Formulary of
India, Part –I 18:15, p.-59.
Yasad Bhasma :
Ayurvedic
Formulary of India, Part-I 18:12, P.-60
Selection of Patients -
Inclusion Criteria :
37 cases of NIDDM (from OPD of Rotary
Baidyanath Ayurvedic Treatment & Research Centre, Kolkata), Or
those who are on OHA. of either sex of various occupations i.e.
Students, Housewives, Businessmen, Servicemen or Professionals were
selected for this study. The patients between age range of 29-77yrs
were included in this study.
Exclusion of patients:
Exclude IDDM and complicated patients like
those -Who have developed Retinopathy or Cardiac diseases or any
severe complications. Principal Investigator had the discretion to
exclude any patient not suitable for this study. It was necessary to
take written consent of the Patients, and to inform all details
about this medicine if he asks for it. .
Duration
of Study:-
Each patient took this medication for
the period of three months and their all parameters were recorded
fortnightly. The total study period was of 6 months duration.
Investigation:-
General investigations such as Height,
Weight, B.P and BMI, along with laboratory investigation done by the investigator was recorded every fortnight. Blood Glucose and Urine Glucose-
Fasting Or, Post meal was recorded
Dose
of the medicine: One teaspoonful twice-daily 15
minutes before breakfast and Dinner.
Adverse effect:-
At each monthly follow-up, patients were
interrogated and examined for any adverse effect and were recorded
in terms of months when reported, its severity, whether there was
discontinuation of the study drug or reduced in the dose of
treatment or other treatments for side effects, was noted.
Case record sheet:-
The case record sheet was filled up by the
investigator throughout the study period. At the end of the study,
the original copy of each completed case record sheet duly signed
and completed in all respect was forwarded to GOOD CARE PHARMA PVT.
LTD., along with the final report.
Concluding
remarks by the investigator: -
How was the patient compliance?
What was the average reduction of Blood and
Urine sugar level, and complications due to Hyperglycaemia?
Were there side effects?
There
were 37 patients of either sex included in this study after proper
diagnosis. There were 25 male and 12 females age ranges between 29
yrs to 73 yrs were included. Out of 37 patients 4 patients had skin
eruption and 7 patients had diabetic neuropathy. There was 2 weeks
of wash out period and after that they were put on medicine DIABET
GUARD 1 tsf twice daily before 15 mints of breakfast, and dinner
with water for the period of three months. Every month their Blood
glucose and Urine glucose was monitored and recorded accordingly.
Result
was analyzed and recorded which is given below in the form of table
after completion of the trial period that is 6 months.
|
No.
of patients
|
Bl-Glucose
(Fast Ini.)
|
Bl-
Glucose (Fast –Fin.)
|
Bl-Glucose
(PP-Ini.)
|
Bl-Glucose
(PP-Fin.)
|
Urine
Glucose (I)
|
Urine
Glucose (FI)
|
|
37
|
217
|
176
|
289
|
183
|
+++
|
Nil
|
RESULT : EXCELLENT
- 59%, GOOD –27%, FAIR-3%,POOR-11%
Ø
Blood Glucose
level reduction above 70 mg/dl along with reduction in urine sugar
and their typical sign
symptoms was considered as Excellent.
Ø
70-50mg/dl
reduction of Blood Sugar along with their typical sign &
symptoms was considered as Good.
Ø
Less than
50mg/dl reduction of blood sugar was considered as fair.
Ø
No desired
effect was noted, were treated as Poor.
Ø
There was no
side effect or untoward effect was noted during this study and
feeling well being was observed in most of the patients.
Evaluation
of Anti-Diabetic properties of a herbo -mineral preparation
“DIABETGUARD GRANULES” in cases of Diabetes Mellitus.
CASE
RECORD SHEET
Principal Investigator:-
Co-Investigator:-
Name:-
age :-
sex M/F :-
Married/Unmarried
:-
Education:-
Occupation:-
Address
OPD
No:-
Provisional
Diagnosis:-
Dt of registration:-
-------------------------------------------------------------------------------------------------------
Family
History:-
Past
History:-
Personal
History:-
Addiction-Tea/Coffee/Smoking/Alcoholic
drinks/drugs
Systemic Examination :-
Height:-
Weight:-
B.P:-
Liver
Spleen
Eye
Kidney
Skin
Chest
Heart
Lungs
Others
Laboratory Investigation
- Initial
Final
Blood
Sugar Fasting
Blood
Sugar P.P
Urine
Sugar
Cholesterol
Triglycerides
Others
---------------------------
------------------------
Sign.Principal Investigator
Sign. of Co-Investigator
Research
Findings Main Page
|
