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B.L.D.E UNIVERSITY
BIJAPUR, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
TITLE OF THE TOPIC
“A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS
AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR
SECRETOR STATUS”
DR. MUDDASER MUJAWAR
PG IN MEDICAL PHYSIOLOGY
(M.Sc MEDICAL PHYSIOLOGY)
UNDER THE GUIDANCE
DR.MANJUNATHA. AITHALA.
PROFESSOR AND HEAD OF DEPARTMENT OF PHYSIOLOGY
B.L.D.E.U’S SHRI B.M.PATIL MEDICAL COLLEGE
BIJAPUR-586103
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B.L.D.E.UNIVERSITY
SHRI B.M.PATIL MEDICAL COLLEGE BIJAPUR
1. NAME OF THE CANDIDATE AND
ADDRESS
DR.MUDDASER MUJAWAR
DEPARTMENT OF PHYSIOLOGY
B.L.D.E.U’S SHRI B.M.PATIL MEDICAL
COLLEGE HOSPITAL AND RESEARCH
CENTRE,
BIJAPUR-586103
2. NAME OF THE INSTITUTE B.L.D.E.U’S SHRI B.M.PATIL MEDICAL
COLLEGE HOSPITAL AND RESEARCHCENTRE,
BIJAPUR-586103
3. COURSE OF THE STUDY AND
SUBJECT
3 YEARS, MSc MEDICAL PHYSIOLOGY
4. DATE OF ADMISSION TO THE
COURSE.
02-08-2011
6. TITLE OF THE TOPIC“A STUDY OF DISTRIBUTION
OFABO BLOOD GROUPS AMONG
PATIENTS WITH DIABETES
MELLITUS AND THEIR
SECRETOR STATUS”
7. BRIEF RESUME OF THE
INTENDED WORK.
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF STUDY
ANNEXURE-I
ANNEXURE-I
ANNEXURE-I
MATERIALS AND METHODS
7.1 SOURCE OF DATA ANNEXURE-II
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11
.
NAME AND DESIGNATION
11.1 GUIDE
11.2 SIGNATURE
11.3 HEAD OF THE DEPARTMENT
11.4 SIGNATURE
DR. MANJUNATHA. AITHALA.
M.D.PHYSIOLOGY
PROFESSOR AND HEAD
DEPARTMENT OF PHYSIOLOGY
DR. MANJUNATHA. AITHALA.
M.D.(MEDICAL PHYSIOLOGY)
PROFESSOR AND HEAD
DEPARTMENT OF PHYSIOLOGY
12
.
12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
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ANNEXURE – I
6. Brief resume of the intended work
NEED FOR THE STUDY
Interest in the presence of and importance of blood groups had aroused during second halfof 19th century because of conclusive association of blood groups and its roles inpathogenesis of erythroblastosis foetalis. So far, more than 20 genetic polymorphism havebeen shown to be there in the antigens of the red cells and serum proteins. Theagglutinogens in each system are determined by allelic genes occurring at specific loci onthe chromosomes.1
Moreover, each system of antigens inherited independently of other system. Thedifferent frequency of occurrence in different racial groups, importance of is sensitization,the simple mode of inheritance to serve as genetic markers and the biochemical properties
etc ; all made the study of blood groups as an integral part of serology, anthropology,genetics and as well as biochemistry. 2
ABO blood groups have been co-related with various diseases. Incidence of peptic
ulcer is much higher in blood group “O”, where as cancer of stomach, tumors of
salivary glands, and leprosy are more frequent in “A” group individual. It is
assumed that blood group substances may interact with microbes and makes a
person more or less susceptible to a particular disease. Moreover, progressive less
of blood group substances from the tissues cell make them carcinomatious. 3
Further, co-relation between secretor status and diseases of
gastrointestinal tract has also been worked out. These blood group substances arealso present on leucocytes and seem to affect their property of phagocytosis. 3
Absence of blood group substances in body fluids is a health disadvantage, as this
appears to increase susceptibility to number of diseases. The secretion of the
antigen into saliva and mucous offers added degree of prediction against bacterial
fimbria letins. 4
Earlier studies have indicated that secretor status are more prone to hemolytic
anemia, oral cancer and viral infections , where as diseases like tuberculosis,
Rheumatic fever, juvenile diabetes and various auto immune diseases are more
common in non-secretors. 5
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In the genetics of the secretor system two options exist. A person
can be either a Secretor (Se) or a Non-secretor (se). This is
completely independent of whether an individual is a blood type A,
B, AB, or O. This means that someone can be an ‘A’ Secretor or an
‘A’ Non-secretor, a ‘B’ Secretor or a ‘B’ Non-secretor etc. 6
In a simplified sense, A Secretor is defined as a person who
secretes his blood type antigens into body fluids and secretions like
the saliva in mouth, the mucus in digestive tract and respiratory
cavities, etc. Basically what this means is that a secretor puts
his/her blood type into these body fluids. A Non-secretor on the other
hand puts little to none of his/her blood type into these same fluids.
As a general rule, in the U.S. about 80% of the population are
Secretors remaining 20% are Non-secretors. 6
Despite the fact that the association of blood groups with certain
diseases is clearly demonstrated, and the evidence that blood
groups may play an important role in certain diseases, for example,
peptic ulcer and gastric cancer, some other studies report no
association between ABO blood group with those diseases,
including DM. It is not surprising that the data on association of
diabetes with ABO blood groups is scanty and mostly shows no
association. However, there is evidence of positive association as
well.
In addition, it was found that the A blood group appears with the
highest frequency among Malay healthy controls, but in Indians
blood group B is the most dominant.
In a recent study,it was found that blood group B was prevalent at a
high percentage among patients with DM type 2 – 35.71% in
comparison to that of controls, 22.52%, but there was no
statistically significant difference (P>0.05).
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So, it was concluded that there is an association between blood
groups A and O and DM type 2 and the association is negative as
these groups are less common in diabetics and seems to be
protective from the disease. Large studies in other ethnic groups are
needed to confirm these results. Hence the study has been
undertaken.
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ANNEXURE – I
6 2 Review of Literature:
A study conducted in Bangladesh with a sample size of 2,312 patients and 8,936 controls
that there was no association between ABO blood groups and DM. But results show a
significantly lower percentage of O and A blood groups among diabetic patients, which
means a negative association with these blood groups. A larger sample study will be needed
in our population to further investigate this finding.
A study carried out in India included 511 patients with DM type 2 in Madhya Pradesh. The
samples represented adequately the Brahmin (n=146), Bania (n=127), Kayasth (n=52), Shudra
(n=59), and Muslim groups (n=51). In total, 475 unrelated normal healthy individuals were
sampled randomly from the same area, matching age, sex, socio-economic status, etc., but
not the disease condition. For the ABO blood types, standard serological procedures were
followed. Statistical analysis was done using the Chisquare test and the findings suggested
that there was no association between the ABO . 7
In 2009, a study was conducted to show interrelationship between DM type 2 and ABO
blood groups. It was found that among 70 patients with DM, blood group B was more
common and represented 35.71 compared to that of control, which represented only
22.14 of the sample population, but statistical significance was not achieved. 7
A study was conducted to show the frequencies of blood groups A and B & differences
between populations. The observations raised fundamental questions regarding the causes of
these differences.
From another study it was suggested that P falciparum was in the right position during
evolutionary history to affect the origin and relative proportion of ABO antigens; that the
geographic distribution of ABO antigens worldwide is consistent with a survival advantage in
malaria among group O individuals;9 10
A study was conducted to determine the frequency of ABO and Rhesus (Rh) blood groups in
Pakistan. It was a cross sectional prospective study and was conducted over a period of one
year. 8
Out of 22897 subjects 17141 (74.86 ) were male subjects and 5756(25.140 ) were female. Out of 17141 male subjects 15597 (90.99 ) and out of 5756 female
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subjects 5040 (87.56 ) were found to be Rh-positive. The frequency of Rh-negative group
in male subjects were (9.01 ) where as in female subjects were (12.22 ). The frequency of
A, B, O and AB groups in Rh-positive male subjects were 25.63 , 29.54 , 26.04 and
9.78 , amongst female subjects, it was 24.53 , 28.06 , 25.54 and 9.43 respectively. In
Rh-negative male subjects the frequency of A, B, O and AB is 2.25 , 2.88 , 3.01 and
0.88 , while amongst females it is 3.54 , 4.24 , 3.74 and 0.92 respectively. 8
It was concluded from this study that frequency of Rh-positive blood group was
B, O, A, and AB in both gender, where as the most common Rh-negative in male and female
subjects are O, B, A, AB, and B, O, A, and AB respectively.8
A study was conducted in Non-O blood groups subjects and demonstrated particularly high
risk of severe malarial anemia (e.g. blood group A: case-control OR 1.54, CI 1.22 – 1.96, P =
0.00039; family OR 1.51, CI 1.09 – 2.09, P = 0.014). The higher risk of SA experienced by
individuals with non-O blood groups may reflect a pathophysiological effect, for example
accelerated clearance of erythrocytes bound to iRBC. 9
The analysis strongly supported the hypothesis that blood group O individuals
are relatively protected from severe malaria in comparison to other blood groups,
particularly blood group A and AB. 9
A study was carried out to show Heretability of diabetes mellitus in Ethiopian diabetics in
prospective case control study of 859 diabetic probands and 1059 non-diabetics controls.
There were 445 non-insulin dependent diabetic mellitus ( NIDDM ) and 414 insulin
dependent diabetes mellitus ( IDDM), in the diabetic probands. The study indicated that,
heredity plays an important role in genesis of diabetes mellitus.11
From the above observations it appears that there is variation in difference in the
relationship between blood groups, secretor status and their susceptibility to diseases .
Lokking at the heterogenecity of the results, it is exceedingly difficult to arrive at the cause
effect relationship of blood groups and diabetes mellitus . It is also extremely difficult to
explain in what way, the ABO antigens offer protection or make persons more susceptible to
disease. What is certain from the family and blood group studies is that heredity plays an
important role in aetiology of diabetes mellitus.
Thus as mentioned previously, in the aetiology that genetic inheritance of diabetes is
accepted most widely, it then appears that , the genes for ABO blood groups and secretor
“ e” genes along with the other genetic and environmental factor might influence the
degree of penetrance of a gene or genes responsible for diabetes mellitus.
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The above reviews reveal that , there is a sizeable proportion of evidence for association
between blood group antigens, secretor status and diabetes mellitus, from various parts of
the world. However , there are very few reports involving subjects of Indian origin in this
field. This warrants a study to be conducted to know the association between blood group
antigens, secretor status and diabetes mellitus involving subjects of Indian origin.
ANNEXURE – I
6.3 Objectives Of the study
To study distribution of blood groups among patients with diabetes mellitus &
secretor status compared to healthy individuals of both sexes of BLDE’S SHRI
B.M.PATIL MEDICAL COLLEGE AND HOSPITAL in Bijapur.
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ANNEXURE-II
METHODOLOGY
7.2 Method of collection of Data
Study group: This group will consist of specific group of patients suffering with
either Type I or Type II Diabetes Mellitus and attending Medical OPD and admitted
patients in medical wards in BLDEU’s SHRI B. M. Patil Medical College and
Hospital in Bijapur. The patients are in age group of 17-65 yrs with confirmed
Diabetes Mellitus. Study group includes both male and females subjects.
Control group: Normal healthy subjects attending Diabetic clinic in the BLDEU’s
SHRI B. M. Patil Medical College and Hospital in Bijapur, will be selected for the
control group.
Duration of study: From Feb 2013 to Jan 2014.
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Age of the subjects: In both the groups, subjects are in the age group of 17-65
years will be included.
Size of sample: Both the control and study groups consisted of 110 subjects (55
subjects each)
Sample size is calculated by assuming the error +2.53, by using the formula
n={ z α /2 × σ }2
E
Where zα/2 = Value of Z at α/2 % level of significance
σ = Standard Deviation
E = Permissible error
1)Determination of Diabetic status: The diabetic status of each patient will be
determined by using the criteria of National Diabetes Data Group of National
Institute of Health. The criteria is as follows.
Symptoms of diabetes plus random blood glucose conc. > 11.1 mmol/L (200mg/dl)
OR
Fasting plasma glucose > 7.0 mmol/L (126mg/dl)
OR
Two-hour plasma glucose > 11.1 mmol/L (200mg/dl) during an glucose tolerance
test.
2) Determination of ABO and Rh blood group
3) Determination of Secretor and Non-secretor status
Inclusion criteria:
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1. Only healthy subjects without any family history of diabetes mellitus and
known chronic disease will included in the study as control group.
2. Established diabetic patients of both type I and type II will be included in
study group.
3. Confirmed diabetic patients whose blood sugar level will be controlled on
taking oral hypoglycaemic drugs or insulin will be included in the study
group.
Exclusion criteria: The following subjects will be excluded from the study:
1. Subjects with malignancies like leukemia which leads to weakning or
loss of blood group antigens on cell.2. Subjects associated with gram negative septicaemia, intestinal
obstruction and carcinoma of colon or rectum which leads to acquired
“B” antigen like activity.
3. Subjects with history of recently transfused non-specific group blood
and bone marrow transplantation leading to presence of 2 separate cell
population.
The following parameters will be recorded in the subjects:
I.Record of Physical Anthropometry of subjects.
1. Height (in centimetres): This will be measured with subject standing without
their footwears nearest to 0.1 centimetres.
2. Weight (in kilograms): The subjects will be weighed in standardized machine
with minimum clothing nearest to 0.1 kilogram.
3. Chest circumference: It will be measured at deep inspiration position at thelevel of the nipple with minimum clothing with the help of standard tailor
tape nearest to 0.1centimetre.
4. Body Mass Index (kilogram/meter 2): This is calculated for each subject from
weight in kgs and height in meters by using Quetlet index.
II. Record of physiological parameters.
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1. Pulse rate: It will be expressed as beats per minute by palpating right radial
artery.
2. Blood pressure (SBP and DBP): It will be measured by mercury
sphygmomanometer in mm of Hg.
3. Respiratory rate: It will be expressed as cycles per minute by manual method.
4. Mean arterial pressure (MAP): It will be measured in mm of Hg by using the
following formula
= DBP+1/3 pulse pressure (PP).
III. Method of Assesing secretory status
The presence of blood group antigens in the saliva of the subjects of both groups
will be tested by using Haemaglutination Inhibition Technique.
Statistical Analysis: Statistical analysis is done using Chi Square test for finding the
presence of an association between attributes like blood groups,secretor status, sex
etc.. The results are presented using bar diagrams.
a. Diagrammatic representation.
b. Mean +/- Standard Deviation
c. Chi square test.
d. Correlation and Regression analysis.
7.3. Does the study require any investigation or intervention to be conducted on
workers or other human or animals?
Yes. The study requires recording of various physical and physiological
parameters, as well as determination of ABO, Rh blood group & Secretor status.
However, none of these are invasive and none will interfere with the normal
physiology of the subjects. For this, an informed consent will be obtained from each
subject (Format enclosed in Annexure IV).
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7.4 Has ethical clearance been obtained from your institution in case of 7.3?
To be taken.
ANNEXURE-IV
B. L. D. E. U SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND
RESEARCH CENTRE, BIJAPUR
RESEARCH INFORMED CONSENT FORM
Title of the project: “A STUDY IF DISTRIBUTION OF ABO
BLOOD GROUPS AMONG PATIENTS WITH DIABETES
MELLITUS AND THEIR SECRETOR STATUS”
P rincipal investigator/ P.G.Guide’s name: DR. MANJUNATHA AITHALA MD
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PROF AND HEAD
DEPARTMENT OF PHYSIOLOGY
1: PURPOSE OF RESEARCH:
I have been informed that this study will test relationship between Blood
group, secretory status of the subject to his/her “Diabetes mellitus”. This study will
be useful academically as well as to find out association between Blood group,
secretory status and Diabetes mellitus in patients and normal subjects of both sexes.
2: PROCEDURE:
I understand that, the procedure of the study will involve determination of my
blood groups, secretor status and diabetic status. Procedure is diagnostically invasive
in nature. (Collection of blood sample ) The procedure will not interfere with any of
my physiological parameters and they are non invasive.
3: RISK AND DISCOMFORTS:
I understand that, determination of my blood groups, secretor status and
diabetic status will not cause any discomfort to me and do not involve any risk to my
health.
4: BENEFITS: I understand that my participation in the study may not have a direct
benefit to me but this may have a potential beneficial effect in the field of Diabetes
mellitus in future.
5: CONFIDENTIALITY: I understand that medical information produced by this
study will become part of institutional records and will be subject to the
confidentiality and privacy regulation of the said institute. Information of a sensitive
personal nature will not be a part of medical record, but will be stored in
investigator ’s research file and identified only by a code number. The code key
connecting name two numbers will be kept in a separate secured location.
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If the data to be used for publication in the medical literature and for teaching
purpose no names will be used and other identities such as photographs, audio and
video tapes will be used only with my special written permission. I understand I may
see the photographs and the video tapes and have the audio tapes before giving this
permission.
6: REQUEST FOR MORE INFORMATION:
I understand that I may ask more questions about the study at any
time. Concerned researcher is available to answer my questions or concerns. I
understand that I will be informed of any significant new findings discovered during
the course of this study which might influence my continued participation. If during
the study or later, I wish to discuss my participation in all concerns regarding this
study with a person not directly involved, I am aware that the social worker of the
hospital is available to talk with me. A copy of this consent form will be given to me
to keep for careful re-reading.
7: REFUSAL OR WITHDRAWAL OF PARTICIPATION:
I understand that my participation is voluntary and may refuse to participate
or may withdraw my consent and discontinue participation in the study at any time
without prejudice to my present or future care at this hospital. I also understand that
researcher may terminate my participation in this study at any time after she/he has
explained the reasons for doing so and had helped arrange for my continued care by
my physician or physical therapist if this is appropriate
8: INJURY STATEMENT
I understand that in unlikely event of injury to me resulting directly from my
participation in this study, if such injury were reported promptly, then medical
treatment will be available to me, but no further compensation would be provided. I
understand that by my agreement to participate in this study I am not waiving any of
my legal rights.
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I have explained to ___________________________(Name of subject) the purpose of
the research, the procedure required and the possible risk and benefits to the best of
my ability.
ANNEXURE-II
CONSENT FORM
I confirm that ________Dr Muddaser Mujawar________________________
has explained to me the purpose of research, the study procedure that I will undergo,
and the possible risk and discomforts as well as benefits that I may experience.
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Alternative to my participation in the study, I have also been to give my consent form.
Therefore, I agree to give consent to participate as a subject and this research project.
Participant Date:
Signature of witness Date:
Modified from Portney L.G. Watkins M.P., in Foundation of Clinical Research,
Second Edition, New Jersey, Prentice Hall Health 2000. (A
B.L.D.E.U’S Shri B.M.Patil Medical College, Bijapur
Department of Physiology
CLINICAL PROFORMA
Title : “A STUDY OF DISTRIBUTION OF ABO BLOOD GROUPS
AMONG PATIENTS WITH DIABETES MELLITUS AND THEIR
SECRETOR STATUS”
Name : Age: Sex:
Address & phone no:
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General physical examination
PR: BP: Wt: Ht:
Temperature: RR:
Systemic Examination:
Cardiovascular system:
Respiratory system:
Central nervous system:
Per abdomen:
PARAMETERS FOR STUDY :
1. Blood Sugar Level
2. Fasting
3. Post-Prandial
4. Random
5. Blood Group(ABO & Rh)
6. Secretor status
Signature of PG student Signature of Guide and HOD
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BIODATA OF GUIDE:
1. Name : Dr. Manjunatha Aithala.
2. Designation : Professor and Head Dept of Physiology.
3. Date of Birth : 26/06/1964.
4. Qualificatio : M.B.B.S [Jan1993, Mahadevappa Rampure Medical
College, Gulbarga.
M.D [SEP 2001, B.L.D.E.U’S Shri B.M.Patil Medical
college Bijapur]
5. KMC Registration no : 38820
6. College address : Department of Physiology
B.L.D.E.U’S Shri B.M.Patil Medical College, Bijapur -
586103
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7. Teaching Experience : UG Teaching since 1994.
: PG Teaching since 2007.
8. Contact no : 9902103620.
INVESTIGATOR ’S BIO-DATA
1. Name : Dr. Muddaser Mujawar
2. Qualification : B.H.M.S [ 2010, A.M.SHAIKH HOMOEOPATHIC
MEDICAL COLLEGE, BELGAUM ]
3. Registration No : A. 10850
4.Address for Correspondence : Department of Physiology. B.L.D.E.U
Shri .B.M.Patil Medical college Bijapur. – 586103
5. Mobile no. : 9590713327