Proforma for Registration of Subject For s5

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

Miss. DIVYA.K.K I YEAR M.Sc. NURSING MEDICAL AND SURGICAL NURSING YEAR 2013-2015.

PADMASHREE COLLEGE OF NURSING GURUKRUPA LAYOUT, NAGARBHAVI BANGALORE-560072

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BENGALURU, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

1 DISSERTATION

1 NAME OF THE MISS.DIVYA.K.K CANDIDATE AND 1st year M.Sc Nursing, ADDRESS Gurukrupa layout, Nagarbhavi. Bangalore-560072.

2 NAME OF THE Padmashree College of Nursing, INSTITUTE Bangalore.

3 COURSE OF THE STUDY 1styear M.Sc. nursing, AND SUBJECT Medical Surgical Nursing

4 DATE OF ADMISSION 12. 6.2013

5 TITLE OF THE STUDY A study to assess the effectiveness of Okra (lady’s finger) juice as home remedy for regulating blood sugar level among adults with Diabetes Mellitus at selected community area, Bangalore

6. BRIEF RESUME OF THE INTENDED WORK

6.1 INTRODUCTION “Every human being is an author of his own health’’-Hendry

Good health is a pre requisite of human productive and development process. In the past most individuals and societies viewed good health or wellness as the opposite or absence of disease.Health is a multidimensional concept and must be viewed from broader perspective. An assessment of the clients state of health is an important aspect of nursing.1

2 Diabetes mellitus is chronic multisystem disease related to abnormal insulin production, impaired insulin utilization, or both.1.The prevalence of diabetes worldwide has more than doubled since 1980, climbing from an estimated 153 million three decades ago to about 347 million in 2008.3

According to WHO report, today around 346 million people worldwide have diabetes.In 2004, an estimated 3.4 million people died from consequences of high blood sugar 3. About one in every 10 men around the world and one in every 11 women suffers from this disorder. In 2002, more than 18 million Americans, that is about 6.9% of the U.S. population, have diabetes.4

According to the Diabetes Atlas published by the International Diabetes Federation, the number of people with diabetes in India currently is around 40.9 million and is expected to rise to 69.9 million by 2025 unless urgent preventive steps are taken.3India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “Diabetes capital of the world”.5

The prevalence of diabetes among the adult male residents in Dakshina Karnataka District in the year 2010 was found to be 57% whereas that of females was 43%. 6Around 3.2 million deaths every year are attributable to complications of diabetes: six deaths every minute. India tops the list of 10 countries in numbers of suffers.6 Complication of diabetes mellitus is two types. They are acute and chronic.Acute complication include: Diabetic ketoacidosis(DKA); Hyper glycaemic hyperosmolaris syndrome (HHS);hypoglycaemia ;metformin associated lactic acidosis, MALT. Chronic complication include :Nephropathy; retinopathy; neuropathy; Macrovascular diseases (CHD, peripheralvascular disease,stroke). Okra has a hypoglycaemicaffect so it will help to reduce hypo glycemia. 7

6.2 NEED FOR THE STUDY

Diabetes mellitus is defined as a variable disorder of carbohydrate metabolism caused by a combination of hereditary and environmental factors and usually characterized by inadequate secretion or utilization of insulin, by excessive urine production, by excessive amounts of sugar in the blood and urine, and by thirst, hunger, and loss of weight.6

3 The various healing approaches and therapies that are not based on conventional western medicine but are used along with conventional medicine to cure the disease are being broadly branded under the name of complementary medicine. Complementary therapies can help to restore the body’s natural equilibrium and balance and when the body is relaxed and in balance it can cope with the everyday stresses and strains of life much more effectively. Complementary therapies can; boost the immune system, help eliminate toxins, help relieve pain, improve circulation, improve sleep patterns, increase energy levels, induce deep relaxation, reduce stress and tension, restore balance to body systems.6

Consumption of the indigenous plant materials are in use for the management of diabetic mellitus. Lady finger is considered one of the most popular variable disorder of carbohydrate metabolism caused by a combination of hereditary and environmental factors and usually characterized by inadequate secretion or utilization of insulin, by excessive urine production, by excessive amounts of sugar in the blood and urine, and by thirst, hunger, and loss of weight complementary therapies for diabetic mellitus. The mucilage and superior fibre found in lady finger is believed to stabilize blood sugar as it curbs the rate at which sugar is absorbed from the intestinal tract. Lady finger is a member of the family Malvaceae, and is believed to originate from south eastern part of North America. It is extensively used globally as a vegetable for its nutritional and health benefits.8

Many patients try complementary/alternative medicine for diabetes control. Numerous herbal remedies, non-herbal remedies, and other approaches have been tested, and some seem to have anti-diabetic effects.Lady finger is one of the good herbal remedy for diabetics.2 "Lady’s finger", also known as “Okra”, is one of the highly nutritious vegetables, usually eaten while the pod is green, tender, and immature. Botanically, this perennial flowering plant belongs to the Malvaceae (mallows) family and named scientifically as Abelmoschus esculentus.9

“ In vitro study of the effects of viscous soluble dietary fibres of Abelmoschus esculentus L (Lady’s finger) in lowering intestinal glucose absorption, found out that there is a substantial reductions of diffusion of glucose from water soluble portion of the pods of Abelmoschus esculentus L and Na-Carboxy methylcellulose (Na-CMC) and viscous soluble

4 dietary fibres (VSDF) of the fruits of Abelmoschus esculentus L on intestinal glucose absorption using in vitro model. Diffusion systems were observed compared to control in a concentration-dependent manner (P<0.05) which implicates a possible potential role of viscous soluble dietary fibres (VSDF) of fruits of Abelmoschus esculentus L in lowering postprandial serum glucose.”10

Okra (Abelmoschus esculentus), Fresh, raw pods, Nutrition value per 100g

Principle Nutrient Value Percentage of RDA Energy 1.5% 31 Kcal Carbohydrates 7.03 g 5.4 % Protein 2.0 g 4 % Total Fat 0.1 g 0.5 % Cholesterol 0 mg 0 % Dietary Fiber 9 % 3.2 g Vitamins Folates 88 µg 22% Niacin 1.000 mg 6% Pantothenic acid 0.245 mg 5 % Pyridoxine 0.215 mg 16.5 % Riboflavin 0.060 mg 4.5 % Thiamin 0.200 mg 17 % Vitamin C 21.1 mg 36 % Vitamin A 375 IU 12.5 % Vitamin E 0.36 mg 2.5 % Vitamin K 53 µg 44 %

Electrolytes

Sodium 8 mg 0.5 % Potassium 303 mg 6 % calcium 81 mg 8 % copper 0.094 mg 10 % Iron 0.80 mg 10 % Magnesium 57 mg 14% Manganease 0.990 mg 43 % Phosphorous 63 mg 9 % Selenium 0.7 µg 1 % Zink 0.60 mg 5.5%

5 The investigator during her undergraduate programme had come across the fact that lady’s finger has antiglycaemic effect and she found it curious. As many people in the community have diabetes mellitus, and since lady’s finger is easily available, cheaper, commonly used and easily grown. The investigator felt that the use of lady finger would be economical and acceptable to the people in the reduction of blood sugar.10

6.3 STATEMENT OF THE PROBLEM A study to assess the effectiveness of Okra (lady’s finger) juice as home remedy for regulating blood sugar level among adults with Diabetes Mellitus at selected urban community area, Bangalore.

6.4 OBJECTIVES OF THE STUDY

1. To determine the blood sugar level in both experimental group and control group. 2. To administer the Okra (lady’s finger) juice to reduce the blood sugar level of experimental group.

3. To compare the difference between the post-test blood sugar value of experimental group and control group. 4. To evaluate the effectiveness of Okra (lady’s finger) juice in reduction of blood sugar level of diabetic clients between experimental group and control group. 5. To determine the association of mean blood sugar levels with selected demographic variables in experimental group and control group.

6.5 OPERATIONAL DEFINITION

Effectiveness:

6 In this study, effectiveness refers to determining the extent to which Okra intake has achieved the desired effect by significantly reducing the blood sugar of diabetic client.

Diabetic patients: Diabetic patients refers to the clients the age group of 35 to 60 years are diagnosed to have diabetes mellitus i. e., fasting blood sugar greater than 120 mg/dl.

Okra (lady’s finger): In this study lady’s finger juice will be consumed by the client in the early morning before breakfast for 15 days. Lady’s finger is a member of the family malvaceae.Globally as a vegetable for its nutritional and health benefits.

Home remedy: A home remedy is a treatment to cure for diabetes mellitus.in this study it is a medicine for reducing blood sugar level in diabetic clients.

Blood sugar: The concentration of glucose in the blood. The normal range for blood sugar is 70 to 120 mg/dl.

6.6 ASSUMPTIONS

1. Diabetic patients may be aware of certain home remedies being practiced in controlling the blood sugar level. 2. Okra juice which is a good hypoglycaemic agent may be helpful in reducing the blood sugar level in diabetic patients.

6.7 HYPOTHESIS

7 H1: There will be significant difference between the blood sugar readings before and after the intake of lady’s finger in the experimental and control group H2: There will be significant difference in the post-test blood sugar level of diabetic patients between the experimental and control group. H3: There will be significant association of the mean blood sugar reading with selected demographic variables.

6.8 REVIEW OF LITERATURE

a) Literature review related to complimentary therapy for diabetes mellitus. A study was conducted to evaluate the “Effects of Massage Therapy on African Americans with Type 2 Diabetes Mellitus”. Eleven African American ages 45 to 72, (8 female/3 males) were subjects. Vital signs were obtained before and after each of 20, 60- minute massage therapy sessions. The result predicts that the long-term effects were higher resting heart rate and increased blood flow, while temperature significantly decreased. The study concluded that Massage therapy was feasible, well received and could have potential health benefits.11

A study was conducted on “Type II diabetes mellitus with foot reflex therapy". A sample of 32 cases was randomly divided into two groups. One group was treated with conventional Western medicine hypo glycemic agent plus foot reflex therapy, the other group with the western medicine only, for 30 days. The result predicts that fasting blood glucose levels, platelet aggregation, length and wet weight of the thrombus, senility symptom scores and serum lipid peroxide were greatly reduced in the foot reflex therapy group, while no significant change was observed in the Western medicine group. The study concluded that foot reflex therapy was an effective treatment for type II diabetes mellitis.12

A study was conducted to evaluate the “Effects of a foot-reflexo-massage education program on foot care in diabetic patients” in College of Medicine Kwandong University, Korea. A convenience sample of non-equivalent control group time series design was used. The result predicts significant increase in foot care knowledge, self care behaviour, between the experimental group and the control group over three different times. The study concluded

8 that this study may contribute to develop nursing intervention for foot care of diabetic patients.13

A study was conducted the effectiveness of acupuncture therapy in type 2 diabetes mellitus patients. In this study 20 patients were selected for follow up on the basis of inclusion & exclusion criteria. The main acupoints use were pishu (BL 20), shenshu (BL 23), zusanli (ST 36), sanyinjiao (SP 6), hegu (LI 4), jianjing (GB21), quchi (LI 11), waiguan (TW5), jiexi (St.41), taibai (Sp.3), taichong (Liv3), dazhui (Du14). All the patients were punctured by using acupuncture needle with electric stimulation.(Accu Stimulator Apparatus), by DD wave, and the needles were retained for 20-30 minutes. The treatment was given for 3 months time period. The parameter evaluated were fasting plasma glucose, postprandial plasma glucose, glycosylated haemoglobin (HbA1c), lipid profile and body mass index (BMI). At the end of study period it was observed that acupuncture having overall good impact in most of the parameters. A significant decreased were observed in patients after acupuncture therapy. This study was suggesting that acupuncture therapy was effective in improving glycaemic control, reducing HbA1c, lipid profile and may helpful for reducing the complications in Indian patients with type 2 diabetes mellitus.14

A study was conducted to evaluate the efficacy of “Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease” in Almeria, Spain. A randomized, placebo-controlled trial was undertaken among 98 subjects. The result of the study predicts significant difference in skin blood flow of right and left foot, at 6 months and 1 year. The study concluded that connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of Peripheral Arterial Disease.15 b) Literature review related to lady’s finger for diabetic mellitus. An experimental study was conducted on glucose, insulin, and non-esterified fatty acid responses to ladies finger and pointed guard in type 2 diabetes mellitus. Glycaemic index (GI) and insulin (as measured by C-peptide) responses of lady’s finger (Abelmoschus Escullentus) and pointed guard from Bangladeshi origin were investigated to help in creating a better food exchange table for diabetic patients. Ten diabetic subjects, under a cross-over design, consumed equi-carbohydrate amount (25 gram of total carbohydrate) of the vegetables and white bread with a run in period of seven days between the consecutive items.

9 The serum level of glucose were estimated at 0.0, 15, 30, 45, 60, 90, 120, 150 and 180 min, respectively, NEFA and C-pepticide levels were at 0 and 180 min, only. GI and GL were calculated by standard formula. Both LF and PG showed significantly lower serum glucose value than that of white bread. This study shows that for type 2 DM patient’s blood sugar response after consuming ladies finger was significantly lower when compared with white bread and pointed guard.16.

A Malaysian Diabetes Association reported that diabetes may affect 1.2 million Malaysian and the disease can be developed from as early as seven years old. Many of the side effects of diabetes can be prevented if glucose levels at normal range is being controlled. This includes using natural plants and herbal supplements as the alternative way to manage and control diabetes. In South East Asia region, herbal medicines such as ampalaya leaves are commonly used to treat diabetic patient. There are also other natural plants to manage diabetes such as using abelmoschus esculentus (AE). There had been growing interest among researchers to uncover the bioactive and nutritional properties of AE. Thus, this paper provides an extensive literature review to investigate the current study and topics relevant to the nutritional properties of abelmoschus esculentus as a remedy to manage diabetes mellitus. This effort is seen towards providing the evidence support to motivate more scientific research to uncover more scientific nutritional properties of abelmoschus esculentus that may be benefited by the modern medicine, thus suggesting new potential target for drug discovery.17

In vitro study that was conducted on alpha-glucosidase and alpha-amylase enzyme inhibitory effects in aqueous extracts of Abelmoscus esculentus (lady’s finger) Moench, to provide an evidence for anti-diabetic activity through potential inhibition of alpha- glucosidase and alpha-amylase enzymes using the aqueous extracts of Abelmoschus esculentus (L.) Moench (A. esculentus) peel (AAPP) and seed (AASP). The powdered peel and seed were used for the preparing the aqueous extract. And they concluded that the AAPP and AASP showed appreciable alpha-glucosidase [IC50 = (142.69±0.32) mg/mL and (150.47±0.28) mg/mL] and alpha-amylase [(IC50 = (132.63±0.16) m g/mL and (147.23±0.21) mg/mL] inhibitory effect in a concentration-dependent manner, and confirmed the hypoglycaemic effect in the AAPP and AASP aqueous extracts of A. esculentus.6

10 An experimental research framework to investigate the differential expression analysis of liver tissue in streptozotocin induced diabetic rat in response to Abelmoschus esculentus treatment. The hypoglycaemic effect of water extracts prepared from the fruit of AE was studied in the diabetic rats. All animals were randomly divided into three groups: normally healthy group(N group), streptozocin induced diabetic group (STZ group)and AE treated diabetic group(AE group).Oral application of AE at doses of 100,150,200 mg/kg body weight was given to AE treated diabetic group by single and repeated oral administration. Rats liver from these three groups were subjected to RNA extraction for gene expression analysis. The differential expression study’s was carried out by using real time RT-PCR method. For diabetics specific genes of interest are chosen and the expression level of these genes examined quantitatively. The abnormally expression of genes in STZ groups was rescued by the AE therapy. The expected findings from both in vivo and molecular studies may reveal the anti diabetic properties of the AE and suggest that the plant extract may be used for the management of disease.4

A literature review was done on nutritional properties of Abelmoschus esculentus as remedy to manage diabetes mellitus by Malaysian Diabetes Association in 2009 reported that diabetes may affect 1.2 million Malaysian and this disease can be developed from as early as seven years old. Many of the side effects of diabetes can be prevented if glucose levels at normal range are being controlled. This is possible by using natural plants and herbal supplements’ as the alternative way to manage end control diabetes. It was also reported that in south east Asia region, herbal medicines such as ampalaya leaves and abelmoschus esculentus, were commonly used to treat diabetic patients. This study shows that AE has a hypoglycaemic effect.10

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA The data will be collected from diabetic clients residing in the selected community areas in Bangalore.

7.2 METHODS OF COLLECTION OF DATA

i. RESEARCH DESIGN Quasi experimental design will be adopted for the study.

11 ii. VARIABLES a) Independent variable; Okra (lady’s finger) juice will be used to regulate the blood sugar.

b) Dependent variable Blood sugar level of diabetic patients. c) Demographic variables Age, Gender, Occupation, Family income, Marital status, Type of family, duration of illness, duration of treatment, dietary pattern, exercise pattern, use of hypo glycaemic agents, use of any complimentary medicine. iii. SETTING The study will be conducted in PHC at selected urban community area in Bangalore. iv. POPULATION The study population would consist of diabetic clients aged 35-60 years residing in selected urban community area. v. SAMPLE AND SAMPLE SIZE The selected sample will be randomly assigned to the experimental group and control group by lottery method.In this study, the sample will comprise 60 Diabetic clients from the selected rural areas in Bangalore.30 each will be randomly assigned to the experimental group and the control group. vi. CRITERIA FOR SELECTION OF SAMPLES

Inclusion Criteria  The clients who are diagnosed to have Diabetic clients and in the age group of 35-60 years.  Clients who are have blood sugar level more than 120mg/dl.  Clients who are willing to participate in the study.

Exclusion criteria  Diabetic patients who have any other co-morbidities like arthritis,hypertension.

12  Diabetic patients who are on insulin treatment.  Antenatal mothers. Vii. SAMPLING TECHNIQUE Non-probability sampling will be used to select the samples. viii. TOOL FOR DATA COLLECTION The tool for data collection includes the following-

Section A: To assess the demographic variables which includes- Age, gender, occupation, economical status, marital status, type of family, duration of illness, duration of treatment, dietary pattern, exercisepattern, use of hypo glycemic agents, use of any complimentary medicine.

Section B: To assess the blood sugar level which includes: Glucometer, strip and needle; blood sugar chart. ix. METHOD OF DATA COLLECTION

Phase 1  Prior to the data collection, permission will be obtained from the concerned authority for conducting the study.  Subjects will be selected according to the selected criteria and confidentiality will be assured.  Written informed consent will be obtained from the subjects  The investigator will collect the baseline performa and check the pre-test blood sugar of clients on Day 1 using the glucometer.

Phase 2:  The investigator will instruct the experimental group clients on lady’s finger juice consumption.  Experimental group consumes lady’s finger juice from Day-2 for 15 days.

13  Take two pieces of Lady Finger and remove/cut both ends of each Piece. Also put a small cut in the middle and put these two piece. Cover the glass and keep it at room in glass of water. Cover the glass and keep it at room temperature during night at least 8 hours. Early morning, empty stomach simply removes two pieces of lady Finger from the glass and drinks that water.  Client will record the daily intake of lady finger juice daily in the compliance diary.  The investigator would recheck the blood sugar level of clients using the glucometer on Day 5th, Day11thand again on Day 16th. x. PLAN FOR DATA ANALYSIS Descriptive statistics Mean, median, Standard deviation of blood sugar level, frequency distribution, measures of variables will be used.

Inferential statistics a) Paired t-test will be used to assess the significance of pre and post test of both group. b) Unpaired t-test will be used to assess the significance of post test blood sugar in between the groups. c) Chi-square test used to assess the association between blood sugar level and selected demographic variables. xi. PROJECTED OUT COME The researcher will know the Okra(lady’s finger) juice as home remedy for regulating blood sugar level among adult with diabetes mellitus.

7.3 Does the study require any investigation or intervention to the patient or other human beings or animals The investigator will instruct the experimental group clients on lady’s finger juice consumption.

14 7.4 Has ethical clearance been obtained from your institution? (Form to be attached) Yes permission will be obtained from the concerned authorities in the selected urban community areas in Bangalore.

15 8. LIST OF REFERENCES

1. Polit. F Denise, Cheryl Tatano Beck. Nursing Research. New Delhi: Lippincott Publishers: 2008.

2. Lewis’ Medical surgical nursing: Assessment and management of clinical problems. Philadelphia: Mosby Elsevier Publication. P. 1246.

3. Diabetes federation. 5th ed. IDF 2011. [online]. Available from: URL:http://www.who.int/mediacentre/factsheets/fs312/en

4. International Diabetes Federation Atlas. 5th ed. IDF 2011. [online]. Available from: URL:http://www.ncbi.nim.nib.gov/pubmed/17496352

5. Mohan V, Sandeep S, Deepa, Shah B, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian Journal of Medical Research 2007;125:217-30

6. Siddartha, Rao PM, Kumari SN, Kumar S, Madhu LN. An epidemiology of prevalence of Type 2 Diabetes among the adult residents in Dakshina Kannada district. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2010 Jul-Sep;1(3):59.2.

7. Nathan DM, Cleary PA, Backlund JY, et al. (December 2005). "Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes". The New England Journal of Medicine 353 (25): 2643–53. doi:10.1056/NEJMoa052187. PMC 2637991. PMID 16371630.

16 8. Hajeera K, Rahman A. In vitro study of the effects of viscous soluble dietary fibres of Abelmoschus L in lowering intestinal glucose absorption. Bangladesh Pharmaceutical Journal 2010 Jul;13(2):0301-4606

9. Nutritional facts of lady’s finger; Available from:URL:www.nutrition-and-you.com.

10. International Conference On Biomedical Engineering and Technology, IPCBEE Vol11 (2011) C(2011) Singapore: IACSIT Press.

11. B.G. Edwards, Effects of massage therapy on African Americans, chp.sagepub.com Nov 10,2011.

12. Wang, X.M., Type II diabetes mellitus with foot reflexology, chuang koh chuang hsi I chief ho teas chi Beijing, vol.13, September 1993, pp 536-538.

13. Ley YH, The effects of a foot-reflexo-massage education program on foot care in diabetic patients, Taehan Kanho Hakhoe chi.2003 Aug;33(5);633-42

14. Grealish L, Lomasney A, Whiteman B Foot massage, A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer, Cancer Nurs. 2000 Jun;23(3):237-43.

15. Castro-Sanchez AM, Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease, Evid Based Complement Alternat Med.2009 Nov 23.

16. Rahman F, Fatema K, Rahim ATMA, Ali. Glucose, insulin and non-esterified fatty acid responses to lady’s finger and pointed gourd in type 2 diabetes mellitus. Asian Journal of Clinical Nutrition 3;25-32.

17. 2011 International Conference on Biomedical Engineering and Technology IPCBEE vol.11 (2011) © (2011)IACSIT Press, Singapore.

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