7.
8. / Brief resume of the intended work
6.1 Need of the Study:
Diabetes mellitus is a nutritional disorder characterized by a lack of the insulin hormone in the blood which leads to abnormalities in the assimilation of carbohydrate by the body. World health organization stress that India will have the greatest magnitude to increase, approximately 170 million people by the year 2025 A.D. International Diabetic federation estimates that upto 10% Indian urban population and 2% rural population above the age of 15 years have diabetes; more than 90% patients in India, suffer from Type II Diabetes.1
Management of diabetes is essential for preventing its complications. Diet, exercise and weight reduction are the most important non-pharmacological therapeutic measures. Those who follow the diet regulation loose an average of 5 kilos after 12 weeks. Their blood sugar, blood pressure and low density lipoprotein also fall significantly.2
In India Diabetes mellitus is a common Problem because of life style, dietary habits, and lack of physical activity, obesity, stress and consumption of oily greasy foods. It is essential to educate the client regarding alternative therapy for reduction of weight, glycemic level and cholesterol level. Alternative medicine modalities include Acupuncture, Ayurvedic treatment, Biofeedback, Chelating therapy; use of natural herbs like milk thistle for example has been observed to be effective in treating number of liver and gall bladder conditions. 3
The increase in use of herbal, medicine occurred because of a growing concern by the general public about the complication and limitations of modern scientific medicine and ‘natural foods.’4 With rising concept evidence based nursing practice in the era of complementary and alternative medicine, the investigator felt needs to determine the effectiveness of fenugreek powder in controlling weight, glycemic and cholesterol level among diabetic clients in a selected hospital, Mangalore.
6.2 Review of literature:
A study was conducted to find out the effect of consumption of powdered fenugreek seeds on blood sugar and glycosylated hemoglobin level in client with Type II diabetes, in Kashmir. 28 patients were divided into 3 groups, 10 gm and 20 gm of powdered fenugreek was fed to group I and group II.Group III did not receive fenugreek powder. Patients were assessed initially and for subsequent 6 weeks on fortnightly basis. The study finding revealed that in group I the initial fasting Blood sugar was 139 ± 33.4 and at the end of 6 week was 121± 25.1 and in group II initially 175 ± 74.2 and at the end of six week 108.5 ± 31.4, Group III initially 143± 52.6 and at the end of six weeks 125 ± 56.25.
A study was conducted in U.K to find the effect of Fenugreek on typeII Diabetes patients. Eighteen patients were selected into 3 group, Group I – Placebo 5 gm each, Group II – Fenugreek pack 25 gm with placebo 25 gm, Group III fenugreek powder 50 gm respectively were given for 20 days. The study revealed that cholesterol level in Group I was 263±17 and after 20 days was 255±29; in group II initially it was 303±90 and reduced to 224±86 and in group III it was 290±110 after 20 days it was 194±11.0. Triglycerides in Group I initially was 144±3.70 and reduced to140±4.1; in group II initially it was 249±22.0 and reduced to 183±28.2; in group III initially it was 242±22.9 and reduced to 147±27.8. LDL level in group I was 167±4.1 and to increased to168±6.4; in group II initially it was 209±6.5 and decreased to 145±7.4 and in group III initially it was 191±12.7 at the end of 20 days it was118±17.6. The study result revealed that there is change in the lipid profile of the patient group I and group III6.
A study was conducted in India, to find out the effect of Fenugreek seeds on glycemic control and insulin resistance in type II Diabetes mellitus .Twenty five newly diagnosed patient with type 2 Diabetes (fasting glucose <200mg) were randomly assigned in to group I and group II .Group I (n=2) received 1 gm/day hydrochloric extract of Fenugreek seeds and group II (n=13) received usual care (dietary control exercise) and placebo capsules for 2 months. The study findings revealed that use of Fenugreek also has favorable effect on hyper triglyceridemia.7
A study was conducted in India, regarding the dose dependent effect of Fenugreek composite in Diabetes with Dyslipidaemia, 80 patients were selected randomly from rural population. 25 gm, 50 gm, 75 gm and 100 gm/day of Fenugreek was given to group I, group II ,group III, groupIV for 4 weeks respectively .The Fenugreek powder preparation were mixed with 2.5 Tulsi leave powder to reduce the bitterness of Fenugreek patient were divided into 5 groups. The study revealed that there is significant decline is fasting blood glucose level and triglycerides. The higher doses of Fenugreek were also found to be effective in control dyslipedemia8…
A study was conducted at Bangalore, Karnataka to evaluate the effect of food product containing Trigonella foenum-graecum seed (Fenugreek) on postprandial blood glucose level. Fenugreek seed and wheat mixed chapatti (food C 1:9) was given for one week to 30 healthy volunteers and 6 type II Diabetes mellitus patients.TypeII Diabetes mellitus patients were to stop hypoglycemic medication one night before the study. The study reveals that, in healthy volunteers and type II diabetic patients, the Glucose index of food C was 60.4±16.4 and 36±12.8, respectively.This is significantly (P< 0.05) lower than the Glucose index of standard food in the two group, which was 76±16.9 and 46.9±15,respectively. This results confirm that fenugreek content is capable of lowering the Glucose index value of the food, and this has a beneficial effect on the postprandial blood glucose levels in persons with type II Diabetes mellitus as well as in healthy people.9
6.3 Statement of the problem:
“Effectiveness of fenugreek powder in controlling weight, glycemic, and cholesterol level among diabetes clients in a selected Hospital, Mangalore”.
6.4 Objectives of the study:
1. To determine the physiological measures like weight, glycemic level and cholesterol level among Diabetic clients.
2. To evaluate the effectiveness of Fenugreek powder in controlling the physiological measures in Diabetic clients.
3. To find out the association between physiological measures and selected demographical variables.
6.5 Operational definitions:
Effectiveness:- In this study it refers to achievement of a desired result that is the extent to which fenugreek powder has achieved desired effect in controlling physiological measures like weight, blood sugar,serum.cholesterol level.
Fenugreek powder:- In this study it refer to fenugreek seeds obtained from Trigonella foenumgmecani a flowering plant, roasted and finally powdered which will consumed by the client in the following manner 20 gm (teaspoon)diluted in 100ml buttermilk/water.
Physiological measure:- In this study physiological measure are blood sugar, weight and serum lipid (cholesterol, LDL,HDL,VLDL and triglycerides) as measured by glucometry, weighing machine ,serum lipid profile respectively.
Diabetic client:- In this study Diabetic client refers to one who is diagnosed as type II Diabetes mellitus and who is only on oral hypoglycemic agent.
6.6 Assumptions:
1. Diabetic client can control their weight, glycemic level and cholesterol level through methods of alternative therapy.
2. Diabetic client are ready to accept to fenugreek powder.
6.7 Delimitations:
The study is delimited to
(1) Client who are not receiving insulin therapy or oral glycemic therapy.
(2) Client who do not have complication related to diabetes mellitus which includes- diabetic retinopathy, diabetic neuropathy and diabetic nephropathy.
6.8 Projected outcome [hypothesis]:
There is significant difference in the post test survey physiological measures like glycemic, weight and cholesterol between the experimental and control group.
Material and methods
7.1 Source of data:
Diabetics’ clients in the selected hospital, Mangalore.
7.1.1 Research design:
A Quasi experimental design with one control and one experimental group.
E O1 X O2
C O3 - O4
E = Experimental Group
on conventional treatment. / C = Control group.
O = observations
(weight, glycemia and serum lipid level). / O1 = Pretest (Experimental group).
O2 = Posttest (Experimental group). / O3 = Pretest (Control group).
O4 = Posttest (Control group). / X = Alternative Therapy (Fenugreek therapy that is 20 gm of Fenugreek powder diluted in water/buttermilk).
7.1.2 Setting:
The study will be conducted at selected Hospital, Mangalore.
7.1.3 Population:
Diabetes client admitted to selected hospital; Mangalore.
7.2 Method of data collection:
7.2.1 Sampling procedure:
Sample for the study will be selected by purposive sampling technique and randomly assigned into control and experimental group.
7.2.2 Sample size:
40 Diabetics clients will be selected for the study. 20 clients in experimental group and 20 in control group.
7.2.3 Inclusion criteria:
1. Diabetic client who are only on oral glycemic drugs.
2. Diabetic client who are willing to consume fenugreek powder as an alternative therapy
3. Diabetic client who do not have complications of Diabetic retinopathy, Diabetic neuropathy and Diabetic nephropathy.
7.2.4 Exclusion criteria:
1. Client who are on insulin therapy.
2. Client who are having complications of Diabetes mellitus.
3 Client having inflammatory bowel diseases e.g. ulcerative colitis
7.2.5 Instruments intended to be used:
1. Physiological parameters assessment profile includes glucometry weighing machine, serum lipid profile respectively.
2. Demographic profile.
7.2.6 Data collection method:
1) Data will be collected after obtaining permission from concerned Hospital authority.
2) Subject will be selected according of the selection criteria of the study.
3) On the first day, examination of fasting blood sugar and serum lipid (Cholesterol, LDL, HDL, VLDL and weight) will be measured.
4) On the second day, the investigator will explain the client about importance of fenugreek powder and Diabetic clients are asked to take fenugreek powder 20 gm/ 3 times in a day with water/buttermilk for 6 weeks.
5) At the end of 6 weeks, investigator will measure weight, fasting blood sugar, cholesterol, triglycerides, LDL & HDL.
7.2.7 Data analysis plan:
Data will be analyzed using descriptive and inferential statistics.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animal? If so please describe briefly.
Yes, fenugreek seed powder will be administered to experimental group patients.
7.4 Has ethical clearance been obtained from institution in case of 7.3?
Yes, ethical clearance will be obtained from the concerned authority.
List of reference
1. N.P. Amitrthavenim, P.T. Vijay Kumar. Impact of flaxseed Based Therapeutic food on selected Type II Diabetic Patient. The India Journal of Nutrition Dietitian. Volume 43, 2006: 141.
2. DR. Makol Neelam, Diabetics the silent killer disease. Health action. June 2005.
3. DR. Hans Diehl, Diabetics Disease of Affluence. Herald of Health. February, 1990: Pp 14-16.
4. K. Fontaine, Healing Practices. Alternative therapies for Nursing, upper saddle River. Prentice Hall, NJ 2000.
5. A. Hzargad, Nehru, Anjali B.La Wat, F.A .Dat, Effect of consumption of powered fenugreek seed on Blood Sugar and Hb AIC level in Patients with Type II diabetes mellitus. International Journal Diabetic Development countries. Volume – 2, 1992.
6. Patel Ashmi, Hypoglycemic effect of Fenugreek seeds and Karela Juice on patient with Type II Diabetics. 2nd Research elective Resident Journal, Volume IV. 1999-2000: Pp 132-135.
7. M. Prasanna, Hypolipidemic effect of Fenugreek A clinical study. Indian Journal of Pharmacology, Volume: 32, 2000: Pp 34-36.
8. A Mitra, Bhattacharya, Dose Dependent effect of Fenugreek composite in Diabetes with Dyslipidaemia. Indian Journal for the practicing doctors. Volume 3, No 4: 2006-08.
9. Gopalpura PB, Jayanthi C, Dubey S. Effect of Trigonella foenum-graecum seeds on the glycemic index of food: A clinical evaluation. Int J Diab Dev Ctries 2007,27:41-5
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