statement of the problem - Rajiv Gandhi University of Health Sciences

statement of the problem - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT
FOR DISSERTATION
1.
NAME OF THE
Mr. MD HASNAIN ANSARI
CANDIDATE
I YEAR M.Sc. NURSING
AND ADDRESS
E.T.C.M COLLEGE OF NURSING,
P O BOX NO 4, KOLAR – 563 101.
KARNATAKA
2.
3.
4.
NAME OF THE
E.T.C.M COLLEGE OF NURSING,
INSTITUTION
P O BOX NO 4, KOLAR – 563 101, KARNATAKA
COURSE OF
DEGREE OF MASTER OF SCIENCE IN
STUDY AND
NURSING
SUBJECT
MEDICAL SURGICAL NURSING.
DATE OF
ADMISSION TO
15.10.2011
COURSE
5.
TITLE OF THE TOPIC
EFFECTIVENESS
OF
FENUGREEK
SEED
POWDER FOR LOWERING BLOOD SUGAR
AMONG
TYPE
II
DIABETES
PATIENTS
ATTENDING OPD AT E. T. C. M. HOSPITAL
AT KOLAR.
1
6. BRIEF RESUME OF THE INTENDED WORK
“Nothing will benefit human health and increase the chances for survival of life
on Earth as much as the evolution to a vegetarian diet.”
- Albert Einstein
6.1 NEED FOR THE STUDY
Diabetes is a chronic condition marked by abnormally high levels of sugar
(glucose) in the blood. People with diabetes either do not produce enough insulin, a
hormone that is needed to convert sugar, starches and other food into energy needed
for daily life or cannot use the insulin that their bodies produce. As a result, glucose
builds up in the bloodstream. If left untreated, diabetes can lead to blindness, kidney
disease, nerve disease, heart disease, and stroke.1
Globally, the number of adults with diabetes in 2010 was estimated to be 285
million, with prevalence of 6.4 %. By 2030, the estimated number will increase to 439
million with prevalence of 7.7 %. Number of deaths in adult due to diabetes is
estimated to be 3.96 million per year and mortality rate of diabetes in all ages is 6.8
%, at global level.2
According to W.H.O estimates, by 2025 total 380 million of the worldwide
population will be affected from diabetes. For every 21 seconds, someone is
diagnosed with diabetes, and every 10 seconds a person dies from diabetes-related
causes in the world, an estimation given by American Diabetes Association. Its
incidence is increasing rapidly, and it is estimated that by 2030, this number will
almost double.3
2
According to International Diabetes Federation’s (IDF) India is home to over
61 million diabetic patients — an increase from 50.8 million last year. By 2030,
India’s diabetes burden is expected to cross the 100 million. The country is also the
largest contributor to regional mortality with 983,000 deaths caused due to diabetes
this year. IDF’s fifth diabetes atlas has released the staggering figures. IDF says
India’s prevalence of diabetes among 20-79 year olds is 9.2%. India is only second to
China, which has 90 million diabetics (2011) that will increase to about 130 million
by 2030. IDF says, “New figures indicate the number of people living with diabetes is
expected to rise from 366 million this year to 552 million by 2030, if no action is
taken. This equates to approximately three new cases every 10 seconds or almost 10
million per year.” This year, South Asia accounted for 71.4 million diabetics. This
number is expected to increase to 120.9 million by 2030. The Atlas said, “Four in
every five diabetics are between 40 and 59 years.4
A cross-sectional community-based survey was conducted to estimate the
prevalence and study the socio-demographic correlates of type 2 diabetes patients in
Karnataka. The study was carried out on 1,239 respondents, aged above 30 years,
using a two-stage, stratified, random sampling technique. Data was collected by a
personal, face-to-face interview followed by blood sugar estimation using a
glucometer. The overall prevalence of diabetes was 16%. Self-reported diabetes was
11.2%, while 4.8% of previously normal people were found to have high fasting
capillary blood glucose levels. The high prevalence of diabetes in this coastal
population needs further evaluation.5
A stratified multistage sampling design was set to study the results of the first
phase of a national study to determine the prevalence of diabetes and prediabetes
(impaired fasting glucose and/or impaired glucose tolerance) in India. A total of 363
3
primary sampling units (188 urban, 175 rural), in three states (Tamilnadu,
Maharashtra and Jharkhand) and one union territory (Chandigarh) of India were
sampled to survey individuals aged ≥ 20 years. The prevalence rates of diabetes and
prediabetes were assessed by measurement of fasting and 2 hours post glucose load
capillary blood glucose. Of the 16,607 individuals selected for the study, 14,277
(86%) participated, of whom 13,055 gave blood samples. The weighted prevalence of
diabetes (both known and newly diagnosed) was 10.4% in Tamilnadu, 8.4% in
Maharashtra, 5.3% in Jharkhand, and 13.6% in Chandigarh. The prevalences of
prediabetes were 8.3%, 12.8%, 8.1% and 14.6% respectively. The estimation was
that, in 2011, Maharashtra will have 6 million individuals with diabetes and 9.2
million with prediabetes, Tamilnadu will have 4.8 million with diabetes and 3.9
million with prediabetes, Jharkhand will have 0.96 million with diabetes and 1.5
million with prediabetes, and Chandigarh will have 0.12 million with diabetes and
0.13 million with prediabetes. Projections for the whole of India would be 62.4
million people with diabetes and 77.2 million people with prediabetes.6
Fenugreek is one of the oldest medicinal plants, originating in India and
Northern Africa. The leaves and seeds are used to prepare extracts or powders for
medicinal use. Applications of fenugreek were documented in ancient Egypt, where it
was used in incense and to embalm mummies. In ancient Rome, fenugreek was
purportedly used to aid labor and delivery. In traditional Chinese medicine, fenugreek
seeds are used as a tonic, as well as a treatment for weakness and edema of the legs.
In India, fenugreek is commonly consumed as a condiment and used medicinally as a
lactation stimulant. There are numerous other folkloric uses of fenugreek, including
the treatment of indigestion and baldness. The possible hypoglycemic and
4
antihyperlipidemic properties of oral fenugreek seed powder have been suggested by
the results of preliminary animal and human trials.7
A double-blind randomized study was conducted to know the effect of
fenugreek bread on diabetes mellitus 2 patients. A bread incorporating fenugreek
using a proprietary process was tested for its taste acceptability and its effect on
glucose metabolism. Researchers have developed a fenugreek bread formula that was
produced in a commercial bakery by incorporating fenugreek flour into a standard
wheat bread formula. Whole wheat bread was prepared by the same formula in the
same bakery using wheat flour. Total 8 participants were selected who were on diet
control. They were served two slices (56 g) and 5% fenugreek. Blood glucose and
insulin were tested periodically over a 4-hour period after consumption. Persons who
consumed the fenugreek bread, their blood glucose level got decreased. Conclusion of
this study is that fenugreek seed has a medicinal effect for lowering blood glucose
level in type 2 diabetes patients.8
An evaluative study has been conducted which has shown the effects of
fenugreek on hyperglycemia have been attributed to several mechanisms. Researcher
demonstrated in vitro the amino acid 4-hydroxyisoleucine in fenugreek seeds
increased glucose-induced insulin release in human and rat pancreatic islet cells. This
amino acid appeared to act only on pancreatic beta cells, since the levels of
somatostatin and glucagon were not altered. In human studies, fenugreek reduced the
area under the plasma glucose curve and increased the number of insulin receptors,
although the mechanism for this effect is unclear. In humans, fenugreek seeds exert
hypoglycemic effects by stimulating glucose-dependent insulin secretion from
pancreatic beta cells, as well as by inhibiting the activities of alpha-amylase and
sucrase, two intestinal enzymes involved in carbohydrate metabolism. Fenugreek
5
seeds also lower serum triglycerides, total cholesterol, and low-density lipoprotein
cholesterol. These effects may be due to sapogenins, which increase biliary
cholesterol excretion, in turn leading to lowered serum cholesterol levels. The lipidlowering effect of fenugreek might also be attributed to its estrogenic constituent,
indirectly increasing thyroid hormone.7
Medicinal plants have played an important role in treating and preventing a
variety of diseases throughout the world. India still depends on medicinal plants and
most of them have a general knowledge of medicinal plants which are used for
treating a variety of ailments. This survey was undertaken in Lohit district of the
Eastern Arunachal Himalaya in order to inventory the medicinal plants used in folk
medicine to treat diabetes mellitus. Field investigations were conducted in seventeen
remote villages of Lohit district through interviews among 251 key informants who
were selected randomly during our household survey. To elucidate community
domains and determine differences in indigenous traditional knowledge of medicinal
plants with anti-diabetic efficacy, the field survey was repeated again starting from
April 2008 to May 2010 with one hundred traditional healers locally called as "Chau
ya" in Khampti of Lohit district. This study reports an ethnobotanical survey of
medicinal plants in Lohit district of Arunachal Pradesh reputed for the treatment of
diabetes mellitus. Forty-six plant species (including fenugreek) were identified in the
study area to treat diabetes mellitus by the Khamptis "Chau ya" traditional healers.
Comparative published literature survey analysis of this study with other
ethnobotanical surveys of plants used traditionally in treating diabetes mellitus
suggests that eleven plant species make claims of new reports on antidiabetic efficacy.
These plant species are Begonia roxburghii, Calamus tenuis, Callicarpa arborea,
Cuscuta reflexa, Dillenia indica, Diplazium esculentum, Lectuca gracilis, Millingtonia
6
hortensis, Oxalis griffithii, Saccharum spontaneum, and Solanum viarum. The wide
variety of medicinal plants that are used to treat diabetes mellitus in this area supports
the importance of plants in the primary healthcare system of the rural people of Lohit
district of Arunachal Pradesh. The finding of new plant uses in the current study
reveals the importance of the documentation of such ethnobotanical knowledge.9
Diabetes is the single most important metabolic disease, which can affect
nearly every organ and system in the body. It is the most dangerous disease from
which almost every country is suffering. India being the diabetic capital of the world
has more than 50 million people affected by diabetes currently. It can easily be kept in
control with life-style modification. Fenugreek seed powder has an effect to reduce
the blood sugar level. It has a long history of use both as a spice and as a medicine.
Scientists have discovered that fenugreek has insulin-like properties, which is able to
decrease blood glucose levels as well as triglycerides and cholesterol, all of which are
important especially for type 2 diabetes patients. By consuming fenugreek patient can
control the blood sugar with a negligible cost. Indian community has highest rate of
type 2 diabetes mellitus. My research on this topic will help the people to know about
their disease as well as the effect of fenugreek on diabetes mellitus. Fenugreek is
easily accessible in our community, so I think with this research I will be able to serve
really needed people who are suffering from diabetes mellitus.
7
6.2 REVIEW OF THE LITERATURE
One of the most troublesome aspects of good research is a thorough review of
the literature. It involves the systemic identification, factors, location scrutiny and
summary of written materials that contain information on a research problem.10
Review of literature related to the present study is organized under the
following headings.
 Review of literature related to type II diabetes mellitus
 Review of literature related to type II diabetes and fenugreek
Review of literature related to type II diabetes mellitus
A population based experimental study was conducted to estimate the
prevalence and socio-demographic correlates of type II diabetes among adults aged 30
years and above. It was a cross-sectional community-based survey, among individuals
of both gender, aged 30 years and above was carried out in the field practice area of
Kasturba Medical College, Manipal, Karnataka. It was carried out on 1,239
respondents, using a two-stage, stratified, random sampling technique. Data was
collected by a personal, face-to-face interview followed by blood sugar estimation
using a glucometer. The overall prevalence of diabetes was 16%. Self-reported
diabetes was 11.2%, while 4.8% of previously normal people were found to have high
fasting capillary blood glucose levels.11
An evaluative study had been conducted to evaluate the efficacy of portion
control plate for weight loss in obese patients with type II diabetes. Sample size was
130 and was randomly assigned as experimental and control group. Experimental
8
group used portion control plate and control group were on usual care for 6 months
period. Results explored that the interventional group reduced more weight than
control. The portion control plate among diabetes patients had a reduction in their
blood glucose level. The portion control plate also enabled patients with diabetes
mellitus to decrease their hypoglycemic medications without sacrificing glycemic
control.12
They have conducted an experimental study to describe diet and exercise
practice among type II diabetes patient in United States. A sample of 1,480 type II
diabetes patients was selected. Results shows that majority of individuals were
overweight, did not practice the recommended physical activity and dietary guidance.
Study concluded that a constant encouragement on regular physical activity and
dietary habits to control the glycemic effect.13
An experimental study was conducted to assess the combined effect of Triple
Therapy with Rosiglitazone, Metformin, and Insulin Aspart in Type 2 Diabetic
Patients. Sixteen obese type 2 diabetic outpatients on human NPH or MIX (regular +
NPH insulin) insulin twice daily were randomized to either triple therapy, i.e., insulin
as part (a rapid-acting insulin analog) at meals, metformin (which improves hepatic
insulin sensitivity), and rosiglitazone (which improves peripheral insulin sensitivity),
or to continue their NPH or MIX insulin twice 28 daily for 6 months. Insulin doses
were adjusted in both groups based on algorithms. HbA1c, insulin dose,
hypoglycemic episodes, insulin sensitivity (clamp), hepatic glucose production
(tracer), and diurnal profiles of plasma glucose and insulin were used in evaluating
treatment. Result shows that in the triple therapy group, HbA1c declined from 8.8 to
6.8% (P < 0.01) without inducing severe hypoglycemic events. Postprandial
hyperglycemia was generally avoided, and the diurnal profile of serum insulin showed
9
fast and high peaks without any need to increase insulin dose. In the control group,
the insulin dose was increased by 50%, but nevertheless both HbA1c and 24-h blood
glucose profiles remained unchanged. Insulin sensitivity improved in both skeletal
muscle and the liver in the triple therapy group, whereas no change was observed in
the control group.14
Review of literature related to type II diabetes and fenugreek
A randomized experimental study was conducted to assess the effects of
different doses of fenugreek on Type 2 Diabetic patients. Total samples of eighty
people were selected from rural population suffering from type 2 diabetes. Patients
were initially divided in 2 groups of 40 each. 40 patient of a group thus randomly
selected were randomly divided into four sub-groups each containing 10 patients. To
one sub-group 25 g of fenugreek was given and to other sub-groups dose was
increased to 50 g, 75 g and 100g respectively. Each patient in the control group
received normal diet during the entire period of study. Fenugreek seed powder, in
doses of 25 g, 50 g, 75 g and 100 g/day mixed with water as a drink, was consumed
by patients for 2 years in two or three equally divided doses/day, is given to different
study groups respectively, 15 minutes before breakfast, lunch and/or dinner. Blood
glucose estimations over the study period showed a significant decline in fasting
blood glucose levels, and the decline corresponded to the dose of fenugreek.
Comparison of the study and control groups shows that fenugreek had significant
effect in lowering blood sugar.15
A population based experimental study was conducted to assess the effect of
consuming herbal water (Fenugreek seed powder) on glycemic level among adults
10
with type 2 diabetes mellitus. This study was conducted in two selected villages at
kancheepuram district. The sample of 30 type 2 diabetic patients was taken. It had
been equally divided into experimental group and control group, consisting 15
patients in each. 5 g fenugreek seed powder was consumed by the experimental group
for 21 days, whereas the control group was on diet control. In the experimental group
there was significant difference between the mean fasting and postprandial blood
glucose level between pre-test and post-test, but in control group there was no
significant difference.16
A small randomized, controlled double-blind trial study was conducted to
evaluate the effects of fenugreek seeds on glycemic control. Twenty five newly
diagnosed patients with type 2 diabetes were randomly divided into two groups.
Group I (n=12) received 1 gm/day hydroalcoholic extract of fenugreek seeds and
Group II (n=13) received usual care (dietary control, exercise etc). Outcome measures
included mean changes in fasting glucose, oral glucose tolerance, insulin resistance,
and lipid levels. Baseline values were similar between groups. After two months,
mean fasting blood glucose levels were reduced in both groups without significant
differences between groups (148.3 to 119.9 in the fenugreek group vs. 137.5 to 113.0
in the "usual care" group). In addition, there were no significant differences between
groups in mean glucose tolerance test values at the study's end (210.6 to 181.1 vs.
219.9 to 241.6). Significant decreases in triglyceride levels and increases in highdensity lipoproteins were also reported. This study reports a lack of significant
differences between groups in fasting sugars or glucose tolerance. It suggests that
fenugreek seed extract and diet/exercise may be equally effective strategies for
attaining glycemic control in type 2 diabetes. Adjunct use of fenugreek seeds
11
improves glycemic control and decreases insulin resistance in mild type-2 diabetic
patients. There is also a favorable effect on hypertriglyceridemia.17
An evaluative experimental study was conducted to assess hypoglycemic
effect of fenugreek seed powder was studied in 60 non-insulin dependent diabetic
patients. A prescribed diet with and without Fenugreek seed powder was given to
patients for 7 days of a control period and for 24 weeks of the experimental period.
During the experimental period twenty five grams of Fenugreek seed powder divided
into two equal doses was added to the diet and served during lunch and dinner. Diet
containing Fenugreek seed powder lowered fasting blood glucose levels and improved
glucose tolerance. Insulin levels were also diminished. Twenty four hour urinary
sugar excretion was reduced significantly (p < 0.001). Glycosylated hemoglobin
measured at the end of the 8th week of Fenugreek seed powder administration was
reduced significantly (p < 0.001). This shows that feeding Fenugreek seed powder is
beneficial to diabetic participants.18
A community based experimental study was conducted to assess the effect of
fenugreek on postprandial glucose and insulin levels following the meal tolerance test
(MTT) was studied in non-insulin dependent diabetics (NIDDM). The addition of
powdered fenugreek seed (15 g) soaked in water significantly reduced the subsequent
postprandial glucose levels. The plasma insulin also tended to be lower in NIDDM
given fenugreek but without a statistical difference. There was no effect of fenugreek
on lipid levels 3 hours following the meal tolerance test. Finally the conclusion of the
study is, Fenugreek have a potential effect on type 2 diabetes mellitus.19
An experimental study was done to know the metabolic and molecular action
of fenugreek in diabetic tissue. Fenugreek is a plant that has been extensively used as
a source of antidiabetic compounds from its seeds and leaf extracts. The result shows
12
that the action of fenugreek in lowering blood glucose levels is almost comparable to
the effect of insulin. Addition of Fenugreek to vanadium significantly removed the
toxicity of vanadium when used to reduce blood glucose levels. Administration of the
various combinations of the antidiabetic compounds to diabetic animals was found to
reverse. Results of the key enzymes of metabolic pathways have been summarized
together with glucose transporter. Findings of this study illustrate and elucidate the
antidiabetic/insulin mimetic effects of Fenugreek, manganese and vanadium. The
conclusion of this study shows that fenugreek has a medicinal effect for lowering
blood sugar level.20
13
STATEMENT OF THE PROBLEM
“A STUDY TO ASSESS THE EFFECTIVENESS OF FENUGREEK
SEED POWDER FOR LOWERING BLOOD SUGAR AMONG TYPE II
DIABETES PATIENTS ATTENDING OPD AT E. T. C. M. HOSPITAL,
KOLAR.”
6.3 OBJECTIVES OF THE STUDY
1. To assess the pretest blood sugar level before administration of fenugreek
among type II diabetes patients in experimental and control group.
2. To administer the fenugreek among experimental group.
3. To compare the post test blood sugar level among type II diabetes patients
in experimental and control group.
4. To determine the association between the post test blood sugar level among
type II diabetes patients in experimental group and selected demographic
variables.
6.4 OPERATIONAL DEFINITIONS
1. Assess: Refers to judgment of blood sugar level among control and
experimental group and difference between pre-test and post-test.
2. Effectiveness: Refers to the outcome of after the administration of
fenugreek seed powder among type II diabetes patients. It is measured in
terms of the difference between pre test and post test blood glucose level.
3. Fenugreek: A powerful spice for controlling blood glucose. It will be
administered in the form of powder 25g daily mixed with water once along
with dinner.
4. Blood sugar: Refers to the level of glucose in the blood (FBS).
14
5. Type II Diabetes Patients: Refers to those patients who are diagnosed to
have type II diabetes mellitus, aged between 40-60 years, whose fasting
blood sugar level will be more than 120mg/dl.
6.5 ASSUMPTIONS

The DM-II patients may have knowledge regarding benefits of fenugreek
seed in controlling blood sugar.

Consumption of fenugreek seed powder will decrease the blood sugar
level.
6.6 NULL-HYPOTHESES OF THE STUDY
H01: There will be no significant difference in blood glucose level before and after
fenugreek administration among type II diabetes patients in experimental group.
H02: There will be no significant difference between post test blood sugar level
among type II diabetes patients in experimental and control group.
H03: There will be no significant association between post test blood sugar level
among type II diabetes patients in experimental group with selected
demographic variable.
6.7 DELIMITATIONS

The study is limited to diabetic-II patients.

The study is limited to patients between40-60 years of age.

The study is limited to both male and female.

The study is limited to E.T.C.M. hospital, Kolar.
15
7. MATERIALS AND METHOD
7.1 SOURCE OF DATA
Diabetic patients (40-60years) attending OPD at E.T.C.M. hospital, Kolar.
7.1.1 RESEARCH APPROACH:
Quantitative research approach.
7.1.2 RESEARCH DESIGN:
A Quasi Experimental research
7.1.3 VARIABLES UNDER THIS STUDY
INDEPENDENT VARIABLE: Fenugreek seed powder.
DEPENDENT VARIABLE: Blood sugar level
EXTRANEOUS VARIABLE: Age, gender, education, occupation, income,
working time, nature of work, duration of diabetes mellitus II.
7.1.4 SETTING OF THE STUDY:
The study will be conducted at OPD of E.T.C.M. hospital, Kolar.
7.1.5 POPULATION:
Diabetic patients (40-60 years), attending OPD at E.T.C.M. hospital Kolar.
7.1.6 SAMPLING TECHNIQUE:
Purposive sampling method will be used.
7.1.7 SAMPLING SIZE:
The total sample of the study will be 50 people, 25 in experimental group and
25 in controlled group.
16
7.1.8 CRITERIA FOR SELECTION OF SAMPLE:
1. INCLUSIVE CRITERIA:

Diabetic –II patients who are willing to participate in the study.

Diabetic-II patients who are available during data collection.

Diabetic patients whose FBS will be >120mg/dl.
2. EXCLUSIVE CRITERIA:

Diabetic-II patients who refuse to participate in this study.

Diabetic patients who are already taking fenugreek seed powder.
7.2 METHOD OF COLLECTION OF DATA
7.2.1 DATA COLLECTION TOOL:

Structured questionnaire will be used to collect demographic data, it consists
of 2 sections.
SECTION A: Demographic data of the
Age, gender, occupation,
education, income of the family, Religion, Type of Family, Marital
Status, Working time and Nature of work.
SECTION B: Duration of diabetes mellitus, family history of DM, bad
habits, and medications used treatment for DM, blood sugar level,
diabetic diet, dietary habits, sleeping hours, exercise, home remedies and
mental stress.

Glucometer will be used to assess the blood glucose level.
17
7.2.2 DATA COLLECTION PROCEDURE:
Phases of the study
Phase-I
A. Screening of prospective participants based on inclusion and exclusion
criteria.
B. Eligible participants will be assessed for fasting blood glucose level by using
glucometer.
C. Following baseline assessment participants will be allotted to experimental
and control group by using purposive sampling technique.
Phase-II
A. Experimental group participants will consume 25 g of fenugreek seed powder
mixed with water taken once along with dinner for 21 days apart from routine
treatment in hospital.
B. Control group will receive routine treatment in hospital.
C. Post assessment of experimental group participants for fasting blood glucose
level after 21 days of fenugreek seed powder administration.
D. Post assessment of control group participants for fasting blood glucose level
after 21 days of routine hospital care.
7.2.3 METHOD OF DATA ANALYSIS:
Descriptive and inferential statistical analysis will be used to analyze the data.
18
DESCRIPTIVE STATISTICS
Descriptive statistics such as mean, mean percentage and standard deviation
will be used to describe demographic characteristics.
INFERENTIAL STATISTICS

Paired‘t’ test, will be used to compare pre and post test blood sugar level.

Chi-square test will be used to find the association between pre-test blood
sugar with selected demographic variables.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE
CONDUCTED ON PATIENTS OR OTHER S OR ANIMALS?
Yes, diabetic patients’ blood glucose level will be assessed using glucometer
before and after administering fenugreek seed powder to experimental group and
same fasting blood glucose level will be assessed for control group without fenugreek
administration.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR
INSTITUTION? IN CASE OF 7.3

Yes, Ethical clearance will be obtained from the research committee of ETCM
college of Nursing.

Permission will be obtained from the concerned authority of ETCM hospital,
Kolar.

Informed consent will be obtained from diabetic patients (40-60 years) who
are fulfilling the inclusion criteria.
19
8. LIST OF REFERENCES
1.
Taber’s cyclopedic medical dictionary, 20th edition, F.A. Davis Company.
Page no: - 579-583.
2.
T.S. Sanal, N. S. Nair, P. Adhikari, Factors associated with poor control of
type 2 diabetes mellitus: A systematic review and Meta-analysis, Journal of
Diabetology,
October-2011;
3:1,
Available
at
http://www.journalofdiabetology.org/Pages/Releases/PDFFiles/SixthIssue/
RA-1-JOD-11-007.pdf
3.
WHO (1998). Prevention and Control of Diabetes Mellitus” Report of an
intercountry Workshop, Dhaka,
Bangladesh,
27-30th
April
1998,
SEA/NCD/40
4.
Indias’s Diabetes Burden to cross 100 Million by 2030, The Times of
India, Mumbai Edition, 2011 December 14, Page no 9.
5.
Rao CR, Kamath VG, Shetty A, Kamath A. A study on the prevalence of
type 2 diabetes in coastal Karnataka. International Journal of Diabetes in
Developing Countries. 2010 Apr;30(2):80-5. Available from URL:
http://www.ncbi.nlm.nih.gov/pubmed/20535311 (Login date 16-04-2012).
6.
Anjana RM, Pradeepa R, Deepa M, Datta M, Sudha V, Unnikrishnan R et
al, Prevalence of diabetes and prediabetes in urban and rural India: phase I
results of the Indian Council of Medical Research-India Diabetes (ICMRINDIAB) study, Diabetologia. 2011 Dec; 54(12):3022-7
7.
Ethan Basch, Grace Kuo, Michael Smith, Therapeutic Applications of
Fenugreek, Alternative Medicine Review 2003; Volume 8, Number 1:2027
20
8.
Losso JN, Holliday DL, Finley JW, Martin RJ, Rood JC, Yu Y, Greenway
FL. Fenugreek bread: a treatment for diabetes mellitus. Journal of
Medicinal Food. 2009 Oct;12(5):1046-9.
9.
Tag H, Kalita P, Dwivedi P, Das AK, Namsa ND. Herbal medicines used
in the treatment of diabetes mellitus in Arunachal Himalaya, northeast,
India. Journal of Ethnopharmacology. 2012 Mar 13.
10.
Marilynn J. Wood, Basic Steps in Planning Nursing Research,
6th
edition,
Jones and Bartlett Publisher, Page no. :- 32
11.
Chythra R. Rao, Veena G. Kamath, Avinash Shetty, and Asha Kamath, A
study on the prevalence of type 2 diabetes in coastal Karnataka, (August
2006 – October 2007), International Journal Diabetes in Developing
Countries. 2010 Apr-Jun; 30(2): 80–85,
12.
Pedersen. S.D., Kang. J., & Kline .G.A (2007). Portion control plate for
weight loss in obese
patients with type 2 diabetes mellitus: a controlled
clinical trial. Archives of Internal Medicine.167 (12).1277-83.
13.
Karin.M.,Gayle.R., and Edward .B, Diabetic Diet, Volume-25, Number 10,
October 2002, Page no- 1722-1728
14.
Jan Erik Henriksen., et. al. (2003), The Combined Effect of Triple Therapy
With Rosiglitazone, Metformin, and Insulin Aspart in Type 2 Diabetic
Patients, Diabetic Diet, Volume-26, Number-12, Page no- 3273-3279
15.
Analava Mitra (2006), Dose-dependent effects of Fenugreek composite in
Diabetes with dislipidaemia, Internet Journal of Food Safety, Vol.8, 2006,
Page no- 49-55
21
16.
S. Umadevi, Effect of Consuming Herbal Water on Glycemic Level among
Adults with Type 2 Diabetes Mellitus, Nightingale Nursing times, Volume7, Number- 4, July 2011, Page no- 19-20
17.
Gupta A, Gupta R, Lal B. Effect of fenugreek seeds on glycaemic control
and insulin resistance in type 2 diabetes mellitus: a double blind placebo
controlled study. The Journal of the Association of Physicians of India;
2001, Nov;49: 1057-1061
18.
Sharma RD, Sarkar A, Hazra DK, et al. Use of fenugreek seed powder in
the management of non-insulin dependent diabetes mellitus. Nutrition
Research 1996; 16(8):1331-1339.
19.
Madar Z, Abel R, Samish S, Arad J, Glucose-lowering effect of fenugreek
in non-insulin dependent diabetics, European Journal of Clinical Nutrition
(1988), Volume: 42, Issue: 1, Pages: 51-54. Available from URL:
http://www.ncbi.nlm.nih.gov/pubmed/3286242 (Login Date:- 16-04-2012).
20.
Najma Zaheer B., Pardeep K., Asia T.,R.K. Kale,SM Cowsik and P
Mclean, Metabolic and molecular action of Trigonella foenum-graecum
(fenugreek) and trace metals in experimental diabetic tissues, Journal of
Biosciences, 36(2), June 2011, 383–396
22
9.
SIGNATURE OF THE
CANDIDATE
10. REMARKS OF THE GUIDE The research topic selected is relevant and
feasible for the study.
11. NAME AND DESIGNATION
11.1 GUIDE
MRS. GEETHA GUDIYANNAN
ASST. PROFESSOR
E T C M COLLEGE OF NURSING, KOLAR
11.2 SIGNATURE OF THE
GUIDE
11.3 CO-GUIDE
11.4 SIGNATURE OF THE
CO-GUIDE
11.5 HEAD OF THE
MRS. GEETHA GUDIYANNAN
DEPARTMENT
H. O. D. of medical surgical nursing
E T C M COLLEGE OF NURSING, KOLAR
11.6 SIGNATURE OF THE
HOD
12. 12.1 REMARKS OF THE
PRINCIPAL
The topic was discussed with the members
of research committee and was finalised.
He is permitted to conduct the study.
12.2 SIGNATURE
23