Beruflich Dokumente
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CERTIFICATE OF ORIGINALITY
I hereby declare that this university Project is my own work and that, to the best of my
knowledge and belief, it reproduces no material previously published or written that has
been accepted for the award of any other degree of diploma, except where due
acknowledgement has been made in the text.
(NEHAL JAIN)
Enrollment No.
Date:
3
INDEX
SR.NO PARTICULARS PAGE NO.
INTRODUCTION 5-55
1 1.INTRODUCTION
TO THE TOPIC
2.COMPANY
PROFILE
3.SCOPE AND
IMPORTANCE OF
THE STUDY
4.LITERATURE
REVIEW
RESEARCH 56-77
2 METHODOLOGY
1.OBJECTIVES OF
THE STUDY
2.RESEARCH
DESIGN
a.SAMPLE DESIGN
b.SOURCES OF
DATA COLLECTION
4
ANALYSIS AND 77-80
3 FINDINGS
1.ANALYSIS OF DATA
2.SUMMARY OF
FINDINGS
SUMMARY AND 81-82
4 CONCLUSIONS
CONCLUSION AND
RECOMMENDATIONS
BIBLIOGRAPHY 83
5
5
COMPANY PROFILE
Established in 1973, Micro Labs is a fully integrated
pharmaceutical company, present across the entire
pharmaceutical value chain from Research and
Development, Active Pharmaceutical Ingredients,
Finished Formulations to Marketing and Distribution in
India and overseas.
• Micro is a privately held company, founded by Late
Mr. G. C. Surana, now under the leadership of Mr.
Dilip Surana & Mr. Anand Surana
• Strong Focus in India, with presence in over 40
countries and 3300 product registrations at various
stages
• Ranked amongst top 19 in India with a market share
of 1.95% as per AIOCD-AWACS December 2017
• Leading positions in select therapeutic areas like
Cardiology, Diabetology, Ophthalmology,
Dermatology, Pain / Analgesics etc.
• PAN India sales presence with a large and over 5800
experienced field force
6
• State–of–the–art manufacturing facilities approved
by USFDA, UK-MHRA, etc
• 3 R&D centres with capabilities of ANDAs, DMFs and
NDDS
DOMESTIC OPERATIONS
• Pioneer in specialty marketing, with expert teams
that are built around the specialty customer
• Contributing significantly to the healthcare needs of
domestic market for over 3 decades
• Growing at an annualcompounded growth rate of
14%
• Currently marketing is structured into 19 divisions
each of which is customized to deliver a
promotionalmessage to a certain class of specialty
customer
• Our 5600 medical representatives cover over
250,000 doctors & 180,000 pharmacies
7
GLOBAL FOOTPRINT
• Micro is well poised to achieve in the medium term
status “BIG GENERIC COMPANY” in the global
pharmaceutical space
• Building critical mass in existing markets &
developing business in new market like USA, East
Europe, North Africa and South & Central America
• The group has presence in over 40 countries, with
ground level operations in 15 countries, exporting all
major dosages in every therapeutic segment
Own marketing, regulatory & sales operations in the
following geographies:
• Asia – South East – Thailand, Myanmar, Cambodia,
Vietnam
Far East – Taiwan, Srilanka, Nepal, Philippines,
Malaysia, Indonesia, Singapore
Middle East – Yemen, Iraq, Sudan, UAE
• Europe – CIS – Azerbaijan, Russia, Kazakhstan,
Ukraine, Moldova, Belarus, E.U.
• Africa – South Africa
West Africa – Senegal, Nigeria, Ivory coast,Cameroon
8
East Africa – Kenya, Uganda, Tanzania
North Africa – Algeria, Libya
• South & CentralAmerica – Mexico, Guatemala,
Panama, Dominican Republic, Peru
MANUFACTURING FACILITIES
Total No. of Plants: 13
• 3 Sites in Hosur , Tamil Nadu
• 7 Sites in & around Bangalore
• 1 Site in Pondicherry
• 1 Site in Goa
• 1 site in Sikkim
R&D CAPIBILITIES
The company is committed to doing world-class
research that develops bio-equivalent generics. A
focused effort in defined areas and a lasting interest in
new technology are key features of our efforts to
develop NDDS & innovative combination products in
the medium - long term.
9
• Micro R&D centre is an integrated set up with 3
research centers located in Bangalore & Mumbai.
• Analytical facilities range from compound
identification to bio-analytical capabilities consisting
of all modern equipments.
• The research team comprises of 300 Scientists /
Pharmacists / Analysts / Chemists Microbiologists
engaged in product & analytical development
10
Regulatory Affairs
Well-trained Regulatory Affairs team in India for
preparing technical dossiers to support product
registration
RA
SEMI
REGULATED
REGULATED
MARKETS
MARKETS
Our regulatory team is also placed in various offices
globally such as Philippines, Vietnam, Russia, CIS, UK,
Mexico etc. This helps in better understanding and
13
compliance of local regulatory requirements in
respective region.
Future focus
Strategic alliances from…
Out-licensing projects from our development
pipeline
15
Joint product development / Contract Research with
supply of finished products
Early launch through licensing / Royalty / Profit
Share
Contract manufacturing in regulated markets
In-licensing products / authorized generics for global
sales
16
The Origin
Diabetes-Siphon (Greek)
means melting down of the flesh and limbs into urine
Mellitus - Sweet
sweet urine being symptom of disease.
19
Diabetes
Diabetes is a hormonal disorder where the body isn’t
able to properly use/produce a hormone called insulin
which helps break glucose in our food to convert it to
energy.
High levels of unregulated glucose in the bloodstream
can damage the kidneys, eyes, nerves, even cause
cardiac arrests. Depending on the inability to use or
produce insulin, diabetes has been divided into two
types:
Type I and Type II.
There is also another condition called prediabetes,
where an individual’s blood sugar levels are higher than
the normal level, however, these raised levels are not
enough to diagnose a patient with diabetes.
20
However, a person at this stage is at risk of developing
diabetes in due course.
TYPE 1 Diabetes
Type 1 diabetes is chronic (lifelong)disease that occurs
when the pancreas does not produce enough insulin to
properly control blood sugar levels.
Type 2 diabetes
Type 2 diabetes formerly called non-insulin dependent
diabetes is a disorder that is characterized by high blood
glucose in the context of insulin resistance and relative
insulin deficiency.
Causes of diabetes
While Type I and Type II Diabetes look similar, their
causes are their differentiating points.
• Type I diabetes is caused by an autoimmune
disorder where the immune system mistakes normal
body functions as hostile.
Type II diabetes is caused because the body develops a
resistance to insulin and therefore doesn’t respond
adequately to the hormone.
Symptoms
• While the two types of diabetes have some
common symptoms, they also display some
unique symptoms, which help in differentiating
the two.
22
• There is also the fact that people with type II
diabetes, develop symptoms over a period of
years while the development rate of type I
diabetes is very fast in comparison to the former.
• It should also be noted that if detected in time,
type II diabetes can be prevented, but type I
diabetes cannot be prevented.
• Some of the symptoms are:Polyuria, Polydipsia,
Glycosuria, Polyphagia, Asthenia, Blurring of
vision, Loss of weight etc.
B.E.A.T DIABETES
BE PHYSICAL ACTIVE.
EAT HEALTHY DIET
ABCS ( KNOW AND CONTROL) -
AIC,BLOODPRESSURE CHOLESTROL
,SMOKING
TAKE YOUR MEDICATION
ALT TREATMENT
Balanced diabetes treatments
A variety of different factors have a role to play in
treating diabetes, but the importance of balanced,
co-ordinated diabetes treatment for all diabetics
cannot be underestimated.
Regular and successful treatment decreases the risk
of each patient developing diabetes complications.
25
The basics of diabetes treatment are broken down
into each diabetic type below.
Treatment of Type 1 diabetes
Type 1 diabetes treatment is a daily task. Lack
of insulin production by the pancreas makes Type 1
diabetes is particularly difficult to control.
Treatment requires a strict regimen that typically
includes a carefully calculated diet, planned physical
activity, multiple daily insulin injections and
home blood glucose testing a number of times per
day.
Treatment of Type 2 diabetes
Treatment typically includes diet control, exercise,
home blood glucose testing, and in some cases, oral
medication and/or insulin. Approximately 40% of
people with type 2 diabetes require insulin
injections.
GlucoTrack
Developed by Integrity Applications in Israel,GlucoTrack
can measure blood sugar levels through a combination
of ultrasonic, electromagnetic and thermal waves.
To provide a readout, the sensor is clipped on the ear.
The device is indicated for adults with type 2 diabetes
and is currently approved in Europe, where the
company has just recently started to commercialize the
glucose monitor.
Eversense
27
Developed by Senseonics, Eversense is a subcutaneous
implant that can last for up to 3 months. The device can
measure glucose in the interstitial fluid under the skin of
the arm by using a polymer that fluoresces in response to
the levels of glucose. The data is then sent to transmitter
that displays the glucose levels in real time.
The device recently received FDA approval and the
company struck a deal with Roche to distribute the
sensor.
HbA1c test
Glycosylated Hemoglobin Test (HbAlc)
• The HbAlc test measures blood glucose content
that gets bound to the hemoglobin.
• The hemoglobin comes out of Red Blood cells when
they ‘die’ after completing 120 days of a fixed life-
span
39
• Hence, the glucose component bound to
hemoglobin reflects the patient’s glucose levels in
the last 3 to 4 months.
Classification of Diabetes
Type 1 (IDDM) Type 2 (NIDDM)
• < 5% of cases 90 % of cases
• ß cells are dead Malfunctioning of ß cells /
or peripheral cells
• Insulin not present Insulin is low / normal/
/ negligible even high
Insulin Deficiency(ID)
• Malfunctioning of ß cells
• Quantity of insulin secreted is less
• Insulin is not secreted in biphasic manner
Insulin Resistance(IR)
•A mutant receptor which is unable to recognize
and bind insulin effectively.
•The presence of anti-insulin antibodies which
bind insulin and prevent its binding to receptors.
•The presence of anti-insulin receptor
antibodies which attach to the receptor and
prevent insulin binding to the receptor.
•A mutation in the tyrosine kinase region of the
receptor which prevents signal transduction.
•A mutation in one of the proteins in the signal
transduction pathway.
42
Insulin
(Meaning Island in Latin.
This is how islets looked in pancreas)
• Major hormonal regulator of glucose metabolism.
• First isolated by Banting and Best in 1922 for the
treatment of the so-called“Sugar disease”
• Secreted by beta cells present in the islets of
langerhans.
• Regulates carbohydrate , fats & protein metabolism
Pancreas
A lobulated gland functioning as an exocrine and
endocrine (Secrete hormone directly into blood
stream) organ.
43
The exocrine portion consists of Acini which
secretes pancreatic juice which passes through
common bile duct into the duodenum.
The endocrine portion consists of Islets of
langerhans cosisting of alpha, beta and delta
cells which secretes glucagon, insulin and
somatostatin respectively.
Insulin
secretion triggered by
• hyperglycaemia
• vagal stimulation
• leucine / arginine
• free fatty acids & ketone bodies
• sulphonylurea drugs
secretion enhanced by
• glucagon like peptide (A hormone that stimulates
beta cells to secrete insulin)
secretion inhibited by
• catecholamines
• somatostatin
Insulin –
Action at cellular level
45
Binds to cell-surface insulin receptor
Activates a protein kinase (Tyrosine Kinase)
Leads to downstream intracellular insulin
signalling
Biosynthetic processes of GLUT-4
glucose uptake enhanced
Endocrine causes of
diabetes mellitus
(Very common)
• no insulin production
• insufficient insulin production
• tissue insensitivity to insulin
(Very rare)
47
• increased circulating levels of counterregulatory
hormones
• excessive growth hormone (acromegaly)
• excessive catecholamines
• excessive cortisol (Cushing’s syndrome)
Diabetic nephropathy
• Affects 25% of type 1 and type 2 diabetes patients
• Risk factors similar to those for retinopathy
• Is a progressive condition leading to renal failure
• Characterised by proteinuria and high blood
pressure
Diabetic neuropathy
• Affects type 1 and type 2 diabetes patients similarly
• Risk factors similar to those for retinopathy
• may lead to
• loss of sensation in feet
• foot ulceration
• erectile dysfunction
• gastroparesis and vomiting
• postural hypotension
50
In Type-2 Diabetes
After a period of time
Insulin Deficiency
Insulin Resistance
PROGRESSIVE BETA CELL FAILURE (UKPDS)
51
BIDS
Insulin injections
Action of OHA s
• Sulphonylureas Pancreatic - beta-cell ID
• Biguanides Extra-pancreatic IR
esp: hepatic cells
52
• Glitazone Extra-pancreatic IR
esp: peripheral cells
• Glinides Pancreatic - B - cells ID
• Alpha - glucosidase inhibitors Gut
• DPP IV Inhibitors Gut
Classification of OHAs
1. Sulphonylureas Glibenclamide , Glipizide ,
Gliclazide , Glimepiride
2. Biguanides Metformin
3. Glitazone Pioglitazone
5. Alpha - glucosidase
Inhibitors Acarbose, Miglitol, Voglibose
53
6. DPP – IV inhibitors Sitagliptin, Vildagliptin &
Saxagliptin,Teneligliptin
SULPHONYLUREAS
They were first introduced in 1956
Are classified as
- first generation
- second generation
Best administered 15 -30 minutes before food
No advantage to switch within the same generation
of SU or to combine 2 Sus
SULPHONYLUREAS
Mechanism of action
Pancreas
- stimulate insulin release
54
Extra-pancreatic effect
- improve insulin sensivity?
- a postulation !
# not effective in type I diabetes
BIGUANIDES
Mechanism ofaction
Is unclear
?
- reduce hepatic glucose production
- reduce gastrointestinal absorption ofglucose
- increase insulin-stimulated glucose transport inmuscle
- increase in insulin receptor binding
ORAL AGENTS
CONTRAINDICATIONS
55
Type I Diabetes
Pregnancy and Lactation
Concurrent diseases
- hepatic, renal, or infections
Primary failure
Secondary failure
56
4. RESEARCH METHODOLOGY
Researchmethodsarethetechniques,researchersusetostructureastudy
andtogatherandanalyzeinformationrelevanttothequestion.Methodologyrefersto
thephilosophyonwhichresearchisbased.Thisincludestheassumptionsandvalues
thatserveasthetoolsortechniqueusedtocollectdata.[153]
RESEARCHAPPROACH
RESEARCHDESIGN
TheresearchdesignimpliedforthisstudywasQuasiexperimental–preandposttest
design.[155-158]
Group pre Interv Post Reinfor Post Reinfor post Reinfor Post
Test ention Test cement Test cement Test cement Test
of of of
Interve Interve Interve
ntion ntion ntion
Study
01 X 02 X 03 X 04 X 05
Group
Control
01 02 03 04 05
Group
above
Weeks of
24 28 32 36 36
Gestation
weeks
01- Pretest level of clinical parameters of Gestational DiabetesMellitus
X- YogawhichincludesYogicpositions(SukshmaVyayamas),pranayamaand
02-04–PosttestlevelofclinicalparametersofGestationalDiabetesMellitusand
VARIABLES
IndependentVariable
In this research study the independent variable was the Yoga which
includes Yogic positions (Sukshma Vyayamas), Nadishodana pranayama and
Dhyanam (Meditation) for antenatal mothers with Gestational Diabetes mellitus
DependentVariable
DemographicVariables
ObstetricalVariables
Past obstetricalhistory
Present Obstetricalhistory
The variables were height, gravida, parity, abortions, still birth, death,
number of children and medication taken during pregnancy.
Neonataloutcomevariables:APGARscoreat1stminute,5thminut
eandBirth weight of the baby and Neonatalcomplications.
ExtraneousVariables
In this study the extraneous variables were diet pattern, Mass media
SETTING
POPULATION
PopulationforthisstudyconsistedofantenatalmotherswithGestational
diabetes Mellitus who were attending Antenatal Out Patient Department at
Government General Hospital, Tambaramtaluk.
TargetPopulation
The target population for this study was the entire Antenatal mothers
with the Gestational Diabetes Mellitus.
AccessiblePopulation
The Accessible population for this study was Antenatal Mothers with
GestationalDiabetesMellituswhowereattendingAntenatalOutPatientDepartment at
Government General Hospital, Tambaramtaluk.
SAMPLE
InclusionCriteria
ExclusionCriteria
Thesamplesizeofthisstudywas220antenatalmotherswithGestational
Diabetes Mellitus who were attending the antenatal outpatient department at
Governmentgeneralhospital,Tambaramtaluk.Thestudygroupconsistedof110and
control group consisted of 110.The sample size calculation for the main study was
basedonthepilotstudyvaluesoffastingandpostprandialbloodglucosetest.Onthe
basisofpilotstudyresults,thefastingbloodglucosewas70mm/Hgandpostprandial
blood glucose was 90mm/Hg with standard deviation 32. After yoga therapy it was
expected a difference of 15 mm/Hg in fasting blood glucose and postprandial blood
glucose at 5% level of significance with 90% power. For achieving this difference
therequiredsamplesizewas96antenatalmotherswithGestationalDiabetesMellitus in
each group.15% of dropout was expected during the study. So the estimated
sample size was 110 in each group. Among 220 participants, they were sub divided
in to 27-28 samples in each group in study group and in control group based on the
level of Gestational Diabetes Mellitus as normal tolerance, mild, moderate and
severe.Todetectthesamplesize,thefollowingpoweranalysisformulawasused by
theinvestigator.
Anticipated common SD =
Level of Significance = 100 (1-) %
Power of the Test = 100 (1-) %
Medically Meaningful Difference = d
n = 2 2 (Z+ Z)2
d2
=
= 1.96
= 1.28
d = 15
n = 2 X 322 (1.96 + 1.28) 2 = 96 per group
152
63
DEVELOPMENTANDDESCRIPTIONOFTHETOOLANDSCORING
INTERPRETATIONS
Past obstetricalhistory
ThevariableswerediagnosisofGestationaldiabetesMellitusatprevious
pregnancy in gestational weeks, treatment of gestational diabetes at previous
pregnancy, previous history of type of delivery, weight of the previous child, effect
of diabetes in previous pregnancy, previous history of children with congenital
abnormalities and Family history ofdiabetes.
Present Obstetricalhistory
The variables were height, gravida, parity, abortions, still birth, death,
number of children and medication taken during pregnancy
PartIII:Maternal,fetalandNeonataloutcomevariableproforma
3.10.1.3.3. Neonatal outcome: APGAR score at 1 st minute, 5th minute and Birth
weight of the baby and Neonatal complications.
The total score for the tool for surveillance of clinical parameters were
20(100%) and the total items were 5. It was assessed at the 24th week before Yoga
for study group and Control group, after Yoga with the hospital routine treatment at
28th week,32 week and 36th week in study group and with the hospital routine
treatment alone for Control group. The interpretations of the ranges were as follows
3.10.2.1SCORINGINTERPRETATIONSFORTHECLINICAL
PARAMETERS
Sl.No. Ranges of Clinical parameters Classification Scoring
Reliability: The reliability for the tool for surveillance of clinical parameters of
Gestational Diabetes Mellitus was tested by Cronbach-Alpa, Rater-Inter-rater
method. The reliability was r = 0.78. It shows statistically significant and thus
reliable.
3.10.3SECTIONC:Toassessthelevelofsatisfactiononyogaamongmotherswith
GestationalDiabetesMellitus5pointratingscalewhichwasused.Totallyitconsists
of15itemsanditrangesfrom1-5(Verysatisfied-5,Satisfied-4,Neithersatisfiednor
dissatisfied-3, Dissatisfied-2, Very dissatisfied-1) and it was developed by the
investigator.
DESCRIPTION OF THEINTERVENTION
The intervention package for study group consists of Yoga which
includes Yogic sukshma vyayama(20 -25 mts), Nadishodana pranayama(5-10 mts)
and Dhyanam(5 mts) with hospital routine treatment which includes Counseling on
diet,exercises,andregularmonitoringofbloodglucoselevel,Insulin therapybased
onthebloodglucoselevelandregulardoseofIron,folicacidandCalciumtablets
from 24th week to till delivery. They were instructed to follow up the visitsregularly
in the antenatal outpatient department. The intensive training on yoga was given to
the mothers with GDM for 6 days continuously for 30-40 minutes a day and the
doubts were clarified by the Investigator.
67
After the intensive training of Yoga for 6 days the antenatal mother with
GDM practiced yoga daily at home for 30-40 minutes a day and group session
weekly once was conducted as a reassessment and reinforcement from 24th week to
tilldelivery.Investigatorbyparticipatoryobservationassessedthecorrectpracticeof
the yoga with the check list in every group session to assess the level of practice.
Daily yoga practice calendar was used to verify the regular practice of yoga by the
antenatal mother with GDM.
Intervention Fidelity
Toassessinterventionfidelityin thisstudytheinvestigatorusedchecklist
which consisted of 5 components such as Study design, Treatment and its delivery,
Treatment / Intervention receipt, Treatment enactment and Provider training. This
check list was validated by many experts in the field of research and it was used by
theinvestigator.Thistoolwasusedtoassesstheadherentandcompetentdeliveryof yoga
which includes sukshma vyayama(20 -25 mts), Nadishodana pranayama(5-10 mts)
and Dhyanam(5 mts) with hospital routine treatment (Intervention) by the
interventionist to the antenatal mothers with GDM. The total score was30 out of
69
which this study intervention fidelity score was 27 (90%). Hence the intervention
was delivered adherently and effectively in this study to all the antenatal mothers
with GDM in study group.
TheentireabovesaidtoolsweretranslatedintoTamilbyexpertsandthis
Tamilinstrumentwasbacktranslated in toEnglishbyexpertstoimprovevalidityof the
tool and again the tool was given to experts for Content validity. Based on their
valid suggestions, the tool was prepared andadministered.
The content of the tool was validated by panel of experts from the field
of Nursing (Obstetrics and Gynecology), Obstetricians, Yoga practioners, Bio-
Statistician and Research experts by the Content Validity Index which was prepared
by the Investigator. Minor suggestions and modifications given by the experts were
incorporated in the final preparation of the tool.
RELIABILITY OF THETOOL
ETHICALCONSIDERATIONS
Human rights
1. Formal approval was obtained from the Institutional review board and
InstitutionalethicalcommitteeofSRMUniversity,Kattankulathur,Chennai,
Tamilnadu,India.
2. To executethestudytheresearcherobtainedofficialwrittenpermissionfrom
Directorate of Medical and rural health Services, Chennai, Joint Director of
health services Kancheepuram and Chief Senior Civil surgeon Medical
Officer from Government General Hospital, Tambaram.
3. Content validity was received from the various experts from the field of
Nursing (Obstetrics and Gynecology), Obstetricians, Yoga practioners, Bio-
Statistician and Researchexperts
4. TheinvestigatorwascertifiedtoexecutetheyogaforGestationalDiabetes
Mellitus.
5. PotentialbenefitsandriskwasexplainedtotheAntenatalmotherswith
Gestational DiabetesMellitus.
Dignity
6. Informedconsentwasobtainedfromthesamplesandtheircaretakersrelated to
the study purpose, type of data, nature of commitments, participation and
procedure.
7. Pilot study was executed to check the feasibility and time requirement of
the study.
8. Mothers with Gestational Diabetes Mellitus have the “rights to with draw
the/withholdtheinformation”wasenforcedbeforedatacollection.
Confidentiality
Justice
11. The control group received hospital routine treatment which includes
Counselingondiet,exercises,andregularmonitoringofbloodglucoselevel,
Insulin therapy based on the blood glucose level and regular dose of Iron,
folic acid and Calcium tablets from 24 th week to till delivery
12. Levelofsatisfactionforyogawasassessedinthestudygroup.
PILOTSTUDY
2. Sample size was increased from 160 to 220 including study group and
Controlgroup.
3. Formulatedatooltoassessthematernal,fetalandneonataloutcomeandlevel
of satisfaction onyoga.
METHOD OF DATACOLLECTION
The total data collection process was one year.The researcher obtained
formal written permission from Directorate of Medical and rural health Services,
Chennai, Joint Director of health services Kancheepuram and Chief Senior Civil
surgeon Medical Officer from Government General Hospital, Tambaram Oral,
written consent from the samples and their care takers were received.
Thedatacollectionprocesscompletedforcontrolgrouppriortothestudy
groupanditwasasfollows.Theinvestigatorhadcommunicatedwithalltheantenatal
mothers with Gestational Diabetes Mellitus those who were attending the antenatal
outpatient department at Government general hospital, Tambaram and explained in
detail about the research study, to find out the interested antenatal mothers with
Gestational Diabetes Mellitus for thestudy.
The data collection procedure was started in the month of June 2010 and
it was completed in the month of June 2011.Investigator had attended the antenatal
outpatient department 3days per week that was Monday, Wednesday and Friday, to
select the mothers with Gestational Diabetes Mellitus on the basis of inclusion and
exclusioncriteria.
73
Posttest was done by using the same tool for surveillance of clinical
parameters (fasting and postprandial blood glucose, urine sugar and weight) of
GestationalDiabetesMellitusat28th,32and36thweek(4weeksonce)andMaternal, fetal
th
and neonatal outcome were assessed after 36 week. Maternal, fetal and
neonataloutcomewereassessedfromtheirmedicalrecords.Allthesedatacollection
procedure for control group was completed before the study group data collection
procedure.
delivery.Investigatorbyparticipatoryobservationassessedthecorrectpracticeofthe yoga
with the check list in every groupsession
Posttestwasdoneto assessthetoolforsurveillanceofclinicalparameters
(fasting and postprandial blood glucose, urine sugar and weight) of Gestational
Diabetes Mellitus for study group at 28th, 32 and 36th week
(4 weeks once) and Maternal, fetal and neonatal outcome were assessed after 36th
week and level of satisfaction on yoga was assessed in study group at 28,32 & 36th
week.Maternal,fetalandneonataloutcomewereassessedfromtheirmedicalrecords
DROP OUTANALYSIS
STUDYGROUP
SAMPLE.NO 21 35 51 62 91 95
AGE 32 25 22 31 19 27
REASON D B A C B E
CONTROLGROUP
SAMPLE.NO 45 62
AGE 20 23
REASON D B
76
B. Shifting ofresidence
C. No belief in Yogatherapy
E. Difficulties in practicingyoga
FREQUENCYANDPERCENTAGEDISTRIBUTIONOFDROPOUT
ANALYSIS FOR STUDY AND CONTROLGROUP
The data was collected from 104 mothers with Gestational Diabetes
Mellitus in study group and 108 mothers with Gestational Diabetes Mellitus in
controlgroup.The informationcollectedfromthestudyparticipantswasscoredand
tabulated. The data was entered into the master coding sheet and saved in EXCEL.
Then the data was analyzed using Statistical Package for Social sciences (SPSS-
16).Thedatawasanalyzedbyusingdescriptiveandinferentialstatistics.
77
CHAPTER SUMMARY
Chapter-3 was devoted to the methodology which includes aspects like Research
approach, Research design, Variables in the study,Setting, Population, Sample and
Sample size and its calculation, Sampling technique, Criteria for sample selection,
Development and description of the tool and its scoring procedure, Description of
intervention,Interventionfidelity,Pilotstudy,Validityofthetool,Reliability,Ethical
consideration,Datacollectionprocedure,DropoutsanditsanalysisandPlanfordata
analysis.
Chapter-4:Presentstheanalysisandinterpretationsofdatawhichwascollected
duringthestudy.
78
Population
Setting
Samples
AntenatalMotherswithGestationalDiabetesMellitus
who fulfils the Inclusioncriteria
Sampling Technique
Sample size
AssessmentofthelevelofClinicalParametersofGest
ationalDiabetesMellitus(24,28,
32,36weeksofGestation),Maternal,FoetalandNeon
ataloutcomeinbothStudyand Control Group(After
delivery) and level of satisfaction on yoga in
Study group ( 28, 32,36 weeks ofGestation)
FIG-
3.1SCHEMATICREPRESEN
TATIONOFRESEARCHMET
HO
79
80
80
81
CONCLUSION
Patients' knowledge regarding the treatment and
complications of diabetes showed serious
deficiencies, more so among women, even though
most had been diabetic for years.
1)A significant predictor for lower knowledge scores
was female gender. In this study, the mean score of
the women was 2.84 points lower than that of men
(t = 2.44, P = 0.016).
2)This finding was similar to that reported by
Vishwanathan et al, who conducted a study on the
knowledge of diabetic subjects regarding foot
problems and care of feet.
(3) They demonstrated that a low knowledge score
was more common among women than in men. In a
study conducted in Chandigarh, it was again shown
that knowledge concerning the prevention of
diabetes complications was partial amongst
diabetics, with only 63.3% of the diabetics taking
care of their feet through regular washing.
81
82
(4) The fact that 51 (50.5%) patients thought that
diabetes is curable, and that only 64 (63.4%) patients
correctly said that the treatment continues
throughout the life, may reflect a mentality of
patients that once the blood sugars are controlled,
they can stop taking their medicines. Only 47
(46.5%) correctly said that diabetes is preventable
and only 29 (28.7%) were aware of the causes of
diabetes.
This indicates a significant lack of the knowledge of
primary and primordial prevention of diabetes in the
population. This fact along with that 71 of the 101
(70.3%) patients said that they would either
definitely or probably have taken preventive
measure seriously had they known that diabetes was
preventable means that imparting knowledge
regarding prevention should be a major thrust in the
future.
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BIBLOGRAPHY
In this project report, I have made use of
books,magazines/journals and web sites which have
been referred.All the material detailed below
provides effective help and a guiding layout while
designing this project report.
WEBSITES:
Wikipedia
Microlabs ltd
MAGAZINES:
Pc magazines
Media kit
NEWSPAPERS:
The times of india, The Hindustan times,The
economic times
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