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Brief resume of the intended study
6.1 Need for the study
Diabetes Mellitus is a chronic metabolic disease caused by an absolute or relative lack of insulin and or reduced insulin activity, which results in hyperglycemia and abnormalities in carbohydrate, protein and fat metabolism.The presence of diabetic mellitus confers increased risk of many divesting complications, such as cardiovascular diseases, peripheral vascular diseases1, Coronary artery diseases, stroke, neuropathy, renal failure, retinopathy, amputation and blindness 2. The main disadvantage of current drugs (biguanides, sulfonylureas) is that they have to be given throughout the life and produce side effects 3.
Plants and their bioactive constituents are used for the treatment of diabetes mellitus throughout the world; especially in countries where access to the conventional treatment of diabetes mellitus is inadequate 4.There has been several reports on the hypoglycemic activity of Mangifera indica ⁵, ⁶. Hence, the present study is undertaken to investigate the anti-diabetic effect of Mangifera indica leaf extract alone and in combination with a oral hypoglycemic drug, gliclazide on alloxan induced diabetic rat models.
6.2 Review of literature:
Mangifera indica (Anacardiaceae) is a tree, distributed in rural and semi urban parts of India. It is one of the most important tropical plants marketed in the world7.It is grown widely in different parts of Africa, especially in the southern parts of Nigeria, where it is valued for its edible fruits 8.
There are traditional medicinal uses for the bark, roots and leaves of Mangifera indica throughout the globe. M.indica is used medicinally to treat ailments such as asthma, cough, diarrhoea, dysentery, leucorrhoea, jaundice, pains, malaria 9.
Phytochemical research from different parts of M.indica as demonstrated the presence of phenolic constituents, triterpenes, flavonoids, phytosterol, and polyphenols10-14 .This species is purposed to possess numerous therapeutic uses Including analgesic, antiinflammatory, immunostimulant, antioxidant, spasmolytic, antidiarrhoeal, antilipidemic, antiamoebic, antihelminthic, antiallergic, antibacterial and antidiabetic15,16 applications.
6.3 Objectives of the study:
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To evaluate the effect of Mangifera indica leaves extract on blood glucose in alloxan induced diabetic rats.
2. To evaluate the effect of Mangifera indica leaves extract on the above
parameter in combination with conventional oral antidiabetic agent,
gliclazide.
Material and Methods:
7.1 Source of data:
The study will be carried out in the post graduate research laboratory, Department of Pharmacology, Navodaya Medical College, Raichur. Albino rats, obtained from National Institute of Nutrition, Hyderabad and maintained at Central Animal House of Navodaya Medical College, will be used for the study. Mangifera indica leaves available locally, will be identified and used for the study. Gliclazide will be obtained from pharmaceutical company. Alloxan hydrate, obtained from Sd fine –CHEM Limited, Mumbai, will be used.
 
7.2 Methods of collection of data(including sampling procedures any)
The anti diabetic effect of Mangifera indica leaves extract alone and in combination with conventional oral antidiabetic drug will be studied in experimental rat models.
Preparation of extract:
The leaves of Mangifera indica will be obtained after identification. The leaves will be washed and shade dried, and after grinding in an electric grinder, the powder will be soaked in equal amount of water and stirred intermittently and will be left over night. The macerated pulp will be dried at reduced temperature. This dry mass will serve as aqueous extract of leaves of Mangifera indica for experimentation17.
Animals:
Adult albino rats (200-250 g) of either sex will be used for the study. Rats will be maintained under good laboratory conditions and will have free access of standard pellet diet and water ad libitum. Animals described as fasted will be deprived of food for 18 hours but will have free access to water. Experiments will be conducted according to the ethical norms approved by the Institutional Animal Ethics Committee guidelines of Navodaya Medical College, Raichur.
Induction of diabetes mellitus :
A single dose (125mg/kg Intraperitonial) of alloxan hydrate 5% (dissolved in normal saline) will be used for induction of diabetes mellitus in the rats. The induction of diabetes mellitus will be confirmed after the 5th day of alloxan treatment by estimation of elevated fasting blood glucose level. Only those rats with blood glucose level ≥ 150mg /dl will be included in the study.
Experimental design for anti diabetic activity :
For antidiabetic study, the fasted diabetic rats will be divided in to six groups of six animals each.
Group I : Normal rats receive vehicle (5% gum acacia) only.
Group II : Diabetic control rats – receive vehicle (5% gum acacia) only.
Group III : Diabetic rats – receive Mangifera indica leaves extract 200mg/kg.
Group IV : Diabetic rats – receive Mangifera indica leaves extract 400mg/kg.
Group V : Diabetic rats – receive Gliclazide 2mg/kg.
Group VI : Diabetic rats – receive Gliclazide 4mg/kg.
Group VII : Diabetic rats – receive Mangifera indica leaves extract 200mg/kg
+Gliclazide 2mg/kg.
Treatment with drugs will be started on the 6th day of alloxan treatment. All the drugs will be given orally as a single dose in the morning. The fasting blood glucose levels will be determined on day 0, 10, and 15.
Collection of blood and determination of serum glucose:
Blood will be collected from the tail vein of rats and glucose levels will be estimated using a glucose oxidase peroxidase reactive strips and a glucometer.
Statistical analysis :
The results will be expressed as mean ± SD in each group (n=6). Comparisons will be made by means of one way analysis of variance (ANOVA) test.
7.3 Does the study require any investigation or intervention to be conducted on
Patients or other humans or animals? If so describe briefly.
Study requires animals such as albino rats of either sex weighing 200-250g for
the following experimental study.
To induce diabetes mellitus in the rats by a single dose of alloxan monohydrate
and to study the effect of
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Mangifera indica leaves extract alone and
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In combination with conventional oral anti diabetic agent on blood glucose.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes, Ethical Clearance from the Institutional Animal Ethics Committee of
Navodaya Medical College, Raichur, for carrying out this experimental study in
the rats, has been obtained (Certificate enclosed).
List of references:
1) Bajaj, J.S and Madan , R . Diabetes in tropics and developing countries. IDF .
Bull. , 1995, 38, 5-6 pp.
2) David, M.N.The Pathophysiology of diabetic complications : how much does
the glucose hypothesis explain ? Ann Intern.Med. , 1996, 174, 286-289 pp.
3) Halim E.M. Effect of Coccina indica (L) and Abroma augusta (L) on
Glycemia ,Lipid profile and on indication of end organ damage in
Streptozotocin induced diabetic rats.Indian.j.clin.biochem.,2003,18,54-63 pp.
4) Punitha,R,Vasuderan,K.Manoharan .S. Effect of Pongamia Pinnata flowers on
Blood glucose and oxidative stress in Alloxan induced diabetic rats. Indian
journal of pharmacology. , 2006 , 38 , 62-63 pp.
5) P.kemasari, S.Sangeetha and P. Venkatalakshmi. Antihyperglycaemic activity
Of Mangifera Indica Linn in alloxan induced diabetic rats. ,2011 , 3(5),
653- 659 pp.
6) M.S. Hossain, M.R.I Khan. e t .Al.Research paper. Antidiabetic and
glycogenesis effects of different fractions of ehtanolic extract of leaves of
Mangifera Indica (Linn.) in normal and alloxan induced diabetic rats. J. Med.
Sci. , 2010, 10(4) , 80-86 pp.
7) I.A Ross. Medicinal plants of the world; New Jersey USA : Human Press
Inc. ,1999, 199-202 pp.
8) Nwinuka , Nwibani.M. O. e t . Al. Effects of aqueous extract of Mangifera
Indica L(mango) stem bark on haematological parameters of normal albino
rats. Pakistan Journal of Nutrition. , 2008, 7(5) , 663- 666 pp.
9) B.E Mandunagu, R.V.B Ebana, ED Ekpe. Antimicrobial activity of four
medicinal plants on pathogenic bacteria and phyto pathogenic
fungi.West Aft. J. Biol. Appl’d Chemi. , 1990 , 35 , 25-30 pp .
10) S.Muruganandam, K.Srinivasan .e t .Al. Effect of mangiferin on
hyperglycaemia and atherogenicity in streptozotocin diabetic rats.
J.Ethanopharmacology. , 2005, 93, 497- 501 pp.
11) A.O Aderibigbe, T.S Emudianughe, B.A Lawal. Anti hyperglycaemic
effect of Mangifera indica in rat. phytother Res ., 1999, 13 ,504 -505 pp.
12) Sachin bhusari, Ajit patil .Al. Activity guided isolation of antioxidant
compound from leaves of mangifera indica. International journal of
pharmacy and pharmaceutical sciences. , 2012 ,vol 4 suppl 4.
13) N.A.J Selles, H.T.V Castro . e t . Al. Isolation and quantitative analysis
of phenolic antioxidants,free sugar, and polyols from mango (Mangifera
Indica Linn) stem bark aqueous decoction used in cuba as a nutritional
supplement. J. Agri Food Chem. , 2002 , 50 ,762 - 766 pp.
14) V. Anjaneyulu ,I. S Babu ,J. D Connolly. Hydroxy maniferonic acid from
mangifera indica. Phytochemistry. , 1994, 35 , 1301-1303 pp.
15) M.A Kharn, S.S Nizami. e t . Al. New triterpenes from mangifera indica.
J. Nat Prod. , 1994, 57 , 988-991 pp.
16) N.A Saleh , M Ei- Ansari. Polyphenolics of twenty local varieties of
mangifera indica Planta Med. , 1975, 28 , 124-130 pp.
17) Vats V., Grover J.K. and Rathi S.S. Evaluation of anti-hyperglycemic and
hypoglycemic effect of Tri2onella foenum-graecum Linn, Ocimum sanctum
Linn and Pterocarpus marsupium Linn in normal and alloxanized diabetic
rats. J. Ethno-Pharmacol. , 2002,79, 95-100 pp.
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