(Annexure 13)

Format for Curriculum Vitae for Investigators

Burdwan Medical College, Burdwan, West Bengal, India. PIN- 713104

EC Ref. No.(for office use):

Name:

Present affiliation(Job title, department, and organisation):

Address(Full work address):

Telephone number: Email address:

Qualifications:

Professional registration (Name of body, registration number and date of registration):

Previous and other affiliations(Include previous affiliations in the last 5 years and other current affiliations):

Projects undertaken in the last 5 years:

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Relevant research training/experience in the area25:

Relevant publications (Give references to all relevant publications in the last five years):

Date: Click here to enter a date.

Signature

25
Details of any relevant training in the design or conduct of research, for example in the Ethics Training, Human participants’ protection courses,
Clinical Trials Regulations, Good Clinical Practice, consent, research ethics training or other training appropriate to non-clinical research. Give
the date of the training

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 Application Form for Initial Review

Burdwan Medical College, Burdwan, West Bengal, India. PIN - 713104

EC Ref. No.(for office use):

General Instructions: a) Tick one or more as applicable. Mark NA if not applicable

b) Attach additional sheets if required

SECTION A - BASIC INFORMATION

1. ADMINISTRATIVE DETAILS
(a) Name of Organization:
(b) Name of the Ethics Committee:
(c) Name of Principal Investigator:
(d) Department/Division: (e) Date of Submission: Click here to enter a date.

(f) Type of review requested1:

Exemption from Review Expedited Review Full Committee Review

(g) Title of the study:

Acronym/ Short title, (If any):

(h) Protocol number(If any): Version number:

(i) Details of Investigators:

Name Designation and Department and Address for communication2

Qualification Institution
Principal Investigator/Guide

Co-investigator/student/fellow

(j) Number of studies where applicant is a:

i) Principal Investigator at time of submission: ii) Co-Investigator at time of submission:

(k) Duration of the study:

1 Refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017on Page 36 Table 4.2. for the types of
review
2Include telephone/mobile, fax numbers and email id

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2. FUNDING DETAILS AND BUDGET
(a) Total estimated budget for site:
At site In India Globally
(b) Self-funding Institutional funding Funding agency
(Specify)

SECTION B - RESEARCH RELATED INFORMATION

3. OVERVIEW OF RESEARCH
(a) Lay Summary of study3 (within 300 words)

(b) Type of study:

Basic Sciences Clinical Cross Sectional
Retrospective Epidemiological/ Public Case Control
Health
Prospective Socio-behavioural Cohort
Qualitative Systematic Review
Quantitative Biological
samples/Data
Mixed Method Any others (Specify)

4. METHODOLOGY
(a) Sample size/ No. of Participants (as applicable)
At site In India Globally
Control group Study Group
Justification for the sample size chosen (100 words); In case of qualitative study, mention the criteria
used for saturation

(b) Is there an external laboratory/ outsourcing involved for investigations? 4Yes No NA

(c) How was the scientific quality of the study assessed?
Independent external Review by Review within
review Sponsor/Funder PI’s institution
Review within multi- No Review
centre research group

Date of review: Click here to enter a date.

Comments of Scientific Committee, if any(100 words)

3Summarize in the simplest possible way such that a person with no prior knowledge of the subject can easily understand it.
4If participant samples are sent outside for investigations, provide details of the same and attach relevant documentation such as an MTA/ MoU
etc.
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 SECTION C - PARTICIPANT RELATED INFORMATION
5. RECRUITMENT AND RESEARCH PARTICIPANTS

(a) Type of participants in the study:

Healthy Patient Vulnerable person/ Others
volunteer Special groups (Specify)

Who will do the recruitment?

Participant recruitment methods used:
Posters/ TV/Radio Patients / Telephone
leaflets/Letters ads/Social Family/Friends
media/Institution visiting
website hospitals
Others(Specify)

(b) i. Will there be vulnerable person/special groups involved? Yes No NA

ii. If yes, type of vulnerable person /special groups
Children under 18 yrs Pregnant or lactating women

Differently abled (Mental/Physical) Employees/Students/Nurses/

Staff
Elderly Institutionalized

Economically and socially disadvantaged Refugees/Migrants/Homeless

Terminally Ill (stigmatized or rare
diseases)
Any other (Specify):

iii. Provide justification for inclusion/exclusion

iv. Are there any additional safeguards to protect research participants?

(c) Is there any reimbursement to the participant? Yes No

If yes, Monetary Non-monetary Provide details

(d) Are there any incentives to the participant? Yes No

If yes, Monetary Non-monetary Provide details

(e) Are there any participant recruitment fees/ incentives for the study provided to the PI/ Institution?

If yes, Monetary Non-monetary Provide details Yes No

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6. BENEFITS AND RISKS
(a) i. Are there any anticipated physical/social/psychological discomforts/ risk to participants?
Yes No
If yes, categorize the level of risk 5:
Less than Minimal risk Minimal risk

Minor increase over minimal risk or More than Minimal Risk or High Risk
Low Risk
ii. Describe the risk management strategy:

(b) What are the potential benefits from the study? Yes No If yes, Direct Indirect
For the participant
For the society/community
For improvement in science
Please describe how the benefits justify the risks

(c) Are Adverse Events expected in the study6? Yes No NA

Are reporting procedures and management strategies described in the study? Yes No
If Yes, Specify

7. INFORMED CONSENT

(a) Are you seeking waiver of consent? If yes, please specify reasons and skip to question 8. Yes No

(b) Version number and date of Participant Information Sheet (PIS):

Version number and date of Informed Consent Form (ICF):
(c) Type of consent planned for :
Signed consent Verbal/ oral Witnessed Audio-Video
consent consent (A/V) consent
Consent from LAR For children<7 yrs Verbal assent Written Assent
(If so, specify from parental/LAR from minor (7- from Minor (13-
whom) consent 12 yrs) along 18 yrs) along with
with parental parental consent
consent
Other (specify)
(d) Who will obtain the informed consent?
PI/Co-I Nurse/Counselor Research Staff Other(Specify)

Any tools to be used

5For categories of risk refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017. Page 6 in Table
2.1
6
The term adverse events in this regard encompass both serious and non-serious adverse events.
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(e) Participant Information Sheet(PIS) and Informed Consent Form (ICF)
English Local language other (specify)
List the languages in which translations were done

If translation has not been done, please justify

(f) Provide details of Consent requirement for previously stored samples if used in the study7

(g) Elements contained in the Participant Information Sheet(PIS) and Informed Consent Form (ICF)

Simple language Data/ Sample Compensation for study related injury

sharing
Risks and Need to recontact Statement that consent is voluntary
discomforts
Alternatives to Confidentiality Commercialization/benefit sharing
participation
Right to Storage of Statement that study involves research
withdraw samples
Benefits return of research Use of photographs/ identifying data
results
Purpose and Payment for Contact information of PI and Member
procedure participation Secretary of EC
Others(Specify)

8. PAYMENT/COMPENSATION
(a) Who will bear the costs related to participation and procedures8?
PI Institution Sponsor Other agencies(specify)

(b) Is there a provision for free treatment of research related injuries? Yes No NA

If yes, then who will provide the treatment?

(c) Is there a provision for compensation of research related SAE? If yes, specify. Yes No NA

Sponsor Institution/ Corpus funds Project grants Insurance

(d) Is there any provision for medical treatment or management till the relatedness is determined for
injury to the participants during the study period? If yes, specify. Yes No NA

(e ) Is there a provision for ancillary care for unrelated illness during the study period? If yes, please
specify. Yes No NA

7Information on re-consent requirements can be found at National Ethical Guidelines for Biomedical & Health Research Involving Human
Participants 2017,Page 54 in Section 5.8
8Enclose undertaking from PI confirming the same

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9. STORAGE AND CONFIDENTIALITY
(a) Identifying Information: Study Involves samples/data. If Yes, Specify Yes No NA

Anonymous/unidentified Anonymized: Irreversibly Identifiable

reversibly coded coded
If identifiers must be retained, what additional precautions will be taken to ensure that access is limited
/ data is safeguarded? (e.g. data stored in a cabinet, password protected computer etc.)

(b) Who will be maintaining the data pertaining to the study?

(c) Where will the data be analyzed9 and by whom?

(d) For how long will the data be stored?

(e) Do you propose to use stored samples/data in future studies? Yes No Maybe
If yes, explain how you might use stored material/data in the future?

SECTION D: OTHER ISSUES

10. PUBLICATION, BENEFIT SHARING AND IPR ISSUES

(a) Will the results of the study be reported and disseminated? If yes, specify. Yes No NA

(b) Will you inform participants about the results of the study? Yes No NA

(c) Are there any arrangements for continued provision of the intervention for participants, if effective,
once the study has finished? If yes describe in brief (Max 50 words) Yes No NA

(d) Is there any plan for post research benefit sharing with participants? If yes, specify
Yes No NA

(e) Is there is any commercial value or a plan to patent/IPR issues. If yes, Please provide details
Yes No NA

(f) Do you have any additional information to add in support of theapplication, which is not included
elsewhere in the form? If yes, provide the details. Yes No

9
For example, a data entry room, a protected computer etc.

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 SECTION E: DECLARATION AND CHECKLIST10

11. DECLARATION (Please tick as applicable)

I/We certify that the information provided in this application is complete and correct.

I/We confirm that all investigators have approved the submitted version of proposal/related
documents.

I/We confirm that this study will be conducted in accordance with the latest ICMR National
Ethical Guidelines for Biomedical and Health Research involving Human Participants and other
applicable regulations and guidelines including responsible.
I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act
1940 and its Rules 1945 as amended from time to time, GCP guidelines and other applicable
regulations and guidelines.
I/We will comply with all policies and guidelines of the institute and affiliated/collaborating
institutions where this study will be conducted.
I/We will ensure that personnel performing this study are qualified, appropriately trained and
will adhere to the provisions of the EC approved protocol.
I/We declare that the expenditure in case of injury related to the study will be taken care of.

If applicable, I/We confirm that an undertaking of what will be done with the leftover samples
is provided, if applicable.
I/We confirm that we shall submit any protocol amendments, adverse events report, significant
deviations from protocols, progress reports (if required) and a final report and also participate
in any audit of the study if needed.
I/We confirm that we will maintain accurate and complete records of all aspects of the study.

I/We will protect the privacy of participants and assure safety and confidentiality of study data
and biological samples.
I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have
no conflict of interest (Financial/Non-Financial) with the sponsor(s) and outcome of study.

I/We have the following conflict of interest (PI/Co-PI):

1.
2.
I/We declare/confirm that all necessary government approvals will be obtained as per
requirements wherever applicable.

Name of PI: Signature: Click here to enter a date.

Name of Co-PI: Signature: Click here to enter a date.

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 Name of Guide: Signature: Click here to enter a date.

Name of HOD: Signature: Click here to enter a date.

12. CHECKLIST
Enclosure
S.No Items Yes No NA No. EC Remarks(If
applicable)

ADMINISTRATIVE REQUIREMENTS
1. Cover letter

2. Brief CV of all Investigators

3. Good Clinical Practice (GCP) training of investigators in

last 3 years
4. Approval of Scientific Committee

5. EC clearance of other centers*

6. Agreement between collaborating partners*

7. MTA between collaborating partners*

8. Insurance policy/certificate

9. Evidence of external laboratory credentials in case of an

externally outsourced laboratory study QA/QC
certification

10. Copy of contract or agreement signed with the sponsor or

donor agency
11. Provide all significant previous decisions (e.g. those
leading to a negative decision or modified protocol) by
other ECs/Regulatory authorities for proposed study
(whether in same location or elsewhere) and
modification(s) to protocol

PROPOSAL RELATED
12. Copy of the detailed protocol11

13. Investigators Brochure (If applicable for

drug/biologicals/device trials)

14. Participant Information Sheet(PIS) and Informed Consent

Form (ICF)(English and translated)
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15. Assent form for minors (12-18 years) (English and
Translated)
16. Proforma/Questionnaire / Case Report Forms (CRF)/
Interview guides/ Guides for Focused Group Discussions
(FGDs) (English and translated)

17. Advertisement/material to recruit participants (fliers,

posters etc)
PERMISSION FROM GOVERNING AUTHORITIES
Other Registration/ Required Not Received Applied EC Remarks
permissions required dd/mm/yy
18. CTRI Enter date

19. DCGI Enter date

20. HMSC Enter date

21. NAC-SCRT Enter date

22. ICSCR Enter date

23. RCGM Enter date

24. GEAC Enter date

25. BARC Enter date

26. Tribal Board Enter date

27. Others (Specify) Enter date

ANY OTHER RELEVANT INFORMATION/DOCUMENTS RELATED TO THE STUDY

Item YES NO NA Enclosure EC remarks
no.
28.

29.

10
These formats are adaptable and can be modified by the Ethics Committee members depending on their needs and requirements
Acknowledgement for Receipt of Application (Copy to be provided to PI)
*For multicentric research. MTA-Material transfer agreement; CTRI-Clinical Trial Registry-India; DCGI-Drug Controller General of India;HMSC-
Health Ministry's Screening Committee;NAC-SCRT- National Apex Committee for Stem Cell Research and Therapy;IC-SCR-Institutional committee
for Stem Cell Research;RCGM- Review Committee on Genetic Manipulation;GEAC- Genetic Engineering Approval Committee;BARC- Bhabha
Atomic Research Centre
11Refer to National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017, section 4 page no. 35Box 4.4(b)

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 Synopsis

“A Study On The Correlation Of Serum Magnesium And Hepatic

Encephalopathy In Patients With Liver Cirrhosis In A Tertiary Care
Hospital In Eastern India”

Name of the Guide: Prof. Saumik Datta

Name of the Student: Dr. Arpan Mukhopadhyay
Synopsis / Research Proposal for Dissertation
M.D. General Medicine (2021-2024)

PROPOSED TITLE FOR SYNOPSIS

“A Study On The Correlation Of Serum Magnesium And Hepatic

Encephalopathy In Patients With Liver Cirrhosis In A Tertiary Care
Hospital In Eastern India”

GUIDE –
Prof. Saumik Datta (Professor & H.O.D. Department
of General Medicine, Burdwan MedicalCollege and
Hospital)

Name of the student –

Dr. Arpan Mukhopadhyay (Post- Graduate Trainee,
Department of General Medicine, Burdwan Medical College
and Hospital)
Summary of Research Proposal

1. Name of the Candidate:

Dr. ARPAN MUKHOPADHYAY (Post- Graduate Trainee,
Department of General Medicine, Burdwan Medical College and
Hospital)

2. Name of the Guide:

Prof. SAUMIK DATTA(Professor, Department of General
Medicine, Burdwan Medical College and Hospital)

3. Place of Proposed Research:

In patient Department of General Medicine, Burdwan Medical
College and Hospital

Laboratory support to be provided by:

- Dept. Of Biochemistry (BMC&H)
- Dept. Of Microbiology (BMC&H)
- Dept. Of Radiology (BMC&H)

4. Proposed Topic for Research:

“A Study On The Correlation Of Serum Magnesium And

Hepatic Encephalopathy In Patients With Liver Cirrhosis In A
Tertiary Care Hospital In Eastern India”
 5. Objective of Proposed Research:

a) General objective- To assess the correlation between

intracellular serum magnesium levels and hepatic
encephalopathy using West Haven gradation in patients
with Liver cirrhosis.

b) Specific objective:

1. Primary:

 To estimate the duration of hospital stay and mortality in patients of

hepatic encephalopathy
 To estimate serum albumin, bilirubin, prothombin time in patients
with hepatic encephalopathy .
 To assess presence of ascites by ultrasonography in patients with
hepatic encephalopathy
 To determine the correlation among above mentioned factors .

2. Secondary:

 To assess burden of hepatitis B & C among the patients with hepatic

encephalopathy

6. Background of Present Study:

Cirrhosis is a disease, in which the normal liver tissue undergoes fibrosis

associated with the formation of degenerative nodules. One of the major
complications of liver cirrhosis seen in nearly one-third of patients is
hepatic encephalopathy (HE). Ammonium accumulation is a major cause of
HE and a strong predictor of its severity in patients with chronic liver
failure. The factors predisposing to encephalopathy include a history of
gastrointestinal bleeding, use of diuretics, infections, hyponatremia,
surgery, constipation, renal failure, anemia, and hypoglycemia .

Magnesium is an essential intracellular cation. Magnesium is a mineral

involved in bone health, energy production, metabolic processes,
enzymatic activities, protein synthesis, fat production, nucleic acid
replication, transport systems, muscle contraction, and immune function.
Magnesium deficiency is common in the general population and its
prevalence among patients with cirrhosis is even higher. Thus Magnesium
plays an important role in development of hepatic encephalopathy

7. Methodology:

After approval of the ethics committee of Burdwan Medical College&

Hospital and permission from West Bengal University of Health Sciences,
Kolkata, the present thesis work will be carried out underdepartment of
General Medicine, Burdwan Medical College and Hospital. Estimation of
Serum Magnesium Level will be done in patient with Hepatic
Encephalopathy. Also estimation of other biochemical and Hematological
parameters (like Serum Albumin, Bilirubin, Creatinine, Prothombin Time ,
INR etc.) will be done . Patients’ sex and age, cause of cirrhosis, model
end-stage liver disease (MELD) score, and Child-Pugh-Turcotte (CTP) class
(A, B, or C) will be recorded. Hypomagnesaemia will be defined as a serum
magnesium concentration of less than 1.7 mEq/L
OUTLINE OF PROPOSED RESEARCH TOPIC

Title: “A Study On The Correlation Of Serum Magnesium And

Hepatic Encephalopathy In Patients With Liver Cirrhosis In A
Tertiary Care Hospital In Eastern India”

Introduction:

Cirrhosis of the liver is a growing health problem and death from this condition is
increasing rapidly among both men and women. Cirrhosis is a chronic disease of the
liver in which diffuse destruction and regeneration of hepatic parenchymal cells and
diffuse increase in connective tissue result in disorganization of the lobular
architecture. In hepatic cirrhosis, the presence of any one or more of jaundice, ascites,
portal hypertensive gastrointestinal bleeding, and/or encephalopathy is considered as
Decompensation. Decompensation is a significant risk for mortality. One-year
mortality in compensated cirrhosis is 1–3.4% but in Decompensation it is elevated to
20–57% . Decompensation followed by death is the most serious outcome in patients
suffering from cirrhosis of the liver. Alteration of trace elements may play a vital role
in the process of decompensation . Low serum magnesium level was found which is
common in chronic liver disease. It has been demonstrated that alcohol impairs
magnesium transport and homeostasis in the brain, skeletal muscle, heart, and the
liver . In a randomized clinical trial magnesium treatment was reported to improve
hepatic enzyme levels .Low magnesium is typically due to decreased absorption of
magnesium in the gut or increased excretion of magnesium in the urine. Low
magnesium levels in otherwise healthy people are uncommon. This is because
magnesium levels are largely controlled by the kidneys. The kidneys increase or
decrease excretion (waste) of magnesium based on what the body needs. Continually
low dietary intake of magnesium, excessive loss of magnesium, or the presence of
other chronic conditions can lead to hypomagnesaemia.
Background and Rationale of research:

The role of trace elements in the pathogenesis of liver cirrhosis and its sequel is
still not clearly understood. The evaluation of functions that trace elements play in
health and disease becomes more difficult when it is recognized that there were not
only nutritional but also metabolic interactions among different trace elements.
Several authors have pointed out that levels of a few trace elements like iron and
magnesium are altered in diseases like cirrhosis of the liver, but the alteration is not
uniform and not always they are.
Thus it is justified to know the role of magnesium in the disease process of liver
cirrhosis and hepatic encephalopathy. However, on literature search it is observed
that the number of studies in this field is scarce. Studies, especially from Eastern India
are very few. Hence this study is planned and aims to assess the serum magnesium
level in patients with hepatic encephalopathy.
Review of literature:

 Keren Cohen-Haga et al. found that Magnesium is deficient

among patients with minimal hepatic encephalopathy.
 Xia Peng et al. found that Magnesium deficiency is related to
worse transplant-free survival, infection and the severity of
liver cirrhosis
 Meixi Liu et al. found that magnesium deficiency aggravates
cirrhosis and ALD, and can cause liver cancer progression
 Borna Safarikish et al. found that The prevalence of
hypomagnesemia was higher among cirrhotic patients with
HE than those without this complication.
 Tripti Saxena et al, found that the lower zinc and magnesium
concentrations associated with an increase in cirrhosis
severity
Materials and Methods:

After approval of the scientific committee and the ethics

committee of Burdwan Medical College and Hospital and
permission from West Bengal University of Health Sciences,
Kolkata, the present thesis will be carried out under
department of General Medicine, Burdwan Medical College and
Hospital between August 2022 and January 2024.

A. Study design: Observational cross-sectional analytical

study

B. Study setting: Tertiary Care Hospital

C. Place of study: In patient department of General

Medicine, Burdwan Medical College and Hospital

D. Timeline of study: One and Half years.

Research proposal to be submitted for institutional ethical
clearance.Selection of study subjects and data collection is to
proceed simultaneously.
The data collected is to be compiled and tabulated. The data
is thento be taken up for statistical analysis

E. Study population: Patients of Hepatic

Encephalopathy being admitted to in patient department
of General Medicine from 01/08/2022 to 01/01/2024.
F. Period of study: The study will be conducted over a
period of one and a half years, i.e., December 2022- May
2024.

i. Preparatory phase: 3 months

ii. Data collection phase: 12 months.
iii. Data analysis phase: 1 month.
iv. Report writing and submission: 2 months.

G. Study variables:

1. Independent variables:

i. Age of patients
ii. Sex of patients
iii. Clinical Parameters:

iv. Hematological parameters:

 Serum Magnesium
 Serum Albumin
 Serum Total Bilirubin
 Serum Creatinine
 Prothombin Time
 INR
v. Alcohol Intake history
vi. HBV and HCV status of patients.
 2. Dependent variables:

i. Complete recovery
ii. Death
iii. Duration of hospital stay

Investigations: 1.Serum Magnesium, sodium, potassium Liver

Function Test, Serum Creatinine, Prothombin
Time, INR
2. HBsAg and Anti HCV
3. Ultrasound whole abdomen
4. NCCT scan of Brain
5. Blood Glucose estimation

H. Sample size:

As we know, sample size calculation formula for cross

sectionalstudies, is

𝑃 = expected proportion of Hepatic Encephalopathy in

populationbased on previous studies; and,
𝑑 = absolute error or precision of 5 %
As no recent data available on prevalence of liver cirrhosis in India, we
have used a data of 2015. According to that study prevalence of cirrhosis in
2015 was 270 per 100,000 population.Approximately, one-third of
individuals with cirrhosis develop Hepatic Encephalopathy. Thus, the
prevalence of Hepatic Encephalopathy was 90 per 100,000 population.

Thus,

1.962×90×10
Sample size = 52
= 138

Hence the sample size for this study is 138.

I. Sampling design: Data will be collected consecutively

with due application of inclusion and exclusion criteria.
 Inclusion criteria:
As no standard investigation is available for diagnosis of hepatic encephalopathy, we
have chosen patients based on West Haven Criteria.

Exclusion criteria:

Other clinical condition which can cause altered sensorium

 Patients with hyponatremia

 Patients with hypoglycemia
 Patients with Cerebrovascular accident.
Study Technique:

Ethical clearance:

This study is to be conducted after obtaining due clearance from

institutional ethics committee and no conflicts of interest are
declared.

Statistical Analysis Plan:

The relevant data shall be compiled, tabulated and taken up for

statistical analysis using standard statistical technique.
References:

 Zhou WC, Zhang QB, Qiao L. Pathogenesis of liver cirrhosis. World J

Gastroenterol. 2014
 Sharma B, John S. Hepatic Cirrhosis. StatPearls Publishing; 2019.
 Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008;
 Garcia-Compean D, Jaquez-Quintana JO, Gonzalez-Gonzalez JA,
Maldonado-Garza H. Liver cirrhosis and diabetes: risk factors,
pathophysiology, clinical implications and management. World J
Gastroenterol. 2009;
 Michelli ML. Liver cirrhosis: causes, diagnosis, and treatment. Nova
Biomedical Books; 2011.
 Garcia-Garcia R, Cruz-Gomez AJ, Urios A, Mangas-Losada A, Forn C,
Escudero-Garcia D, et al. Learning and Memory Impairments in
Patients with Minimal Hepatic Encephalopathy are Associated with
Structural and Functional Connectivity Alterations in
Hippocampus. Sci Rep. 2018
 Munoz SJ. Hepatic encephalopathy. Med Clin North Am. 2008;
 Jalan R, Kapoor D. Reversal of diuretic-induced hepatic
encephalopathy with infusion of albumin but not colloid. Clin Sci
(Lond). 2004;
 Kar K, Dasgupta A, Vijaya Bhaskar M, Sudhakar K. Alteration of
micronutrient status in compensated and decompensated liver
cirrhosis. Indian J Clin Biochem. 2014;
 Nangliya V, Sharma A, Yadav D, Sunder S, Nijhawan S, Mishra S. Study
of trace elements in liver cirrhosis patients and their role in prognosis
of disease. Biol Trace Elem Res. 2015;
 Karandish M, Tamimi M, Shayesteh AA, Haghighizadeh MH, Jalali MT.
The effect of magnesium supplementation and weight loss on liver
enzymes in patients with nonalcoholic fatty liver disease. J Res Med
Sci. 2013;
 Ardizzone G, Arrigo A, Schellino MM, Stratta C, Valzan S, Skurzak S, et
al. Neurological complications of liver cirrhosis and orthotopic liver
transplant. Transplant Proc. 2006;
 Cohen-Hagai K, Feldman D, Turani-Feldman T, Hadary R, Lotan S,
Kitay-Cohen Y. Magnesium deficiency and minimal hepatic
 encephalopathy among patients with compensated liver cirrhosis. Isr
Med Assoc J. 2018.
 Gowda PGM, Tembad MM. Study of Serum Magnesium in Liver
Diseases. J Evol Med Dent Sci. 2015;
 Koivisto M, Valta P, Hockerstedt K, Lindgren L. Magnesium depletion
in chronic terminal liver cirrhosis. Clin Transplant. 2002;
 Saxena T, Agarwal BK, Makwane HS, Kare P. Study of Serum Zinc and
Magnesium Levels in Patients of Liver Cirrhosis. Biomed Pharmacol J.
 Turecky L, Kupcova V, Szantova M, Uhlikova E, Viktorinova A, Czirfusz
A. Serum magnesium levels in patients with alcoholic and non-
alcoholic fatty liver. Bratisl Lek. 2006;
 consumption. Magnes Res. 2008;
 Rahelić D, Kujundžić M, Romić Ž, Brkić K, Petrovečki M. Serum
concentration of zinc, copper, manganese and magnesium in patients
with liver cirrhosis. Coll Antropol. 2006;
 Pasqualetti P, Casale R, Colantonio D, Di Lauro G, Festuccia V, Natali
L, et al. Serum levels of magnesium in hepatic cirrhosis. Quad Sclavo
Diagn. 1987;
 Musso CG, Juarez R, Glassock RJ. Water, electrolyte, acid-base, and
trace elements alterations in cirrhotic patients. Int Urol Nephrol.
2018;
 Wu L, Zhu X, Fan L, Kabagambe EK, Song Y, Tao M, et al. Magnesium
intake and mortality due to liver diseases: Results from the Third
National Health and Nutrition Examination Survey Cohort. Sci Rep.
2017;
 Lopes PJ, Mei MF, Guardia AC, Stucchi RS, Udo EY, Warwar MI, et al.
Correlation between serum magnesium levels and hepatic
encephalopathy in immediate post liver transplantation
period. Magnes Res. 2013;
 Li Y, Ji CX, Mei LH, Qiang JW, Ju S. Oral administration of trace
element magnesium significantly improving the cognition and
locomotion in hepatic encephalopathy rats. Sci Rep. 2017;
 Liu M, Yang H, Mao Y. Magnesium and liver disease. Ann Transl Med.
2019;
Clinical Proforma

Serial number:
Patient Particulars:
 Name of patient-
 Age-
 Sex-
 Religion-
 Address-
Symptoms from history:
 Abdominal swelling-
 Yellowish discoloration of skin & mucosa-
 Euphoria/Anxiety-
 Altered consciousness-
 Abnormal movements-
 Neurological deficit-
 History of Alcohol Intake-
 History of Hepatitis
Signs from clinical examinations:
 General survey:

 Systemic examination: Gastrointestinal system And Central nervous system

examination

Investigations:

i. Serum Magnesium, Sodium , Potassium Liver Function Test, Serum

Creatinine, Prothombin Time, INR
ii. HBsAg and Anti HCV
iii. Ultrasound whole abdomen
iv. NCCT scan of Brain
v. Blood glucose estimation
To
The Chairperson,
Institutional Ethics committee,
Burdwan Medical College & Hospital.

Sub: Prayer for ethical clearance for research proposal for MD (General
Medicine) 2021-2024

Sir/ Madam,
This is to inform you that I, Dr. Arpan Mukhopadhyay, Post
Graduate trainee, dept. of general medicine, Burdwan Medical College and
Hospital, submit copies of my synopsis with the title “A Study On The
Correlation Of Serum Magnesium And Hepatic Encephalopathy In Patients
With Liver Cirrhosis In A Tertiary Care Hospital In Eastern India” for your kind
consideration and approval.
The prescribed proforma has been duly filled up and enclosed and the relevant
documents have been enclosed. I will be highly obliged if you are expedient in
approval of my request.

Date: Yours faithfully,

Dr. Arpan Mukhopadhyay

Forwarded by:

Signature and date:

INVESTIGATOR’S UNDERTAKING

I, Dr Arpan Mukhopadhyay, 1st Year Post Graduate trainee, MD (General

Medicine), for the session 2021-2024, hereby declare that I am doing the study
titled “A Study On The Correlation Of Serum Magnesium And Hepatic
Encephalopathy In Patients With Liver Cirrhosis In A Tertiary Care Hospital In
Eastern India” under the guidance and close supervision of Dr. Saumik Datta,
Professor, Department of General Medicine, Burdwan Medical College,
Burdwan as guide, solely for the purpose of my thesis as part- fulfilment of my
MD course. I shall be liable to bring to the notice of the ethics committee, the
developments regarding this study, including any adverse outcome. The
treatment protocol will be in parity with the present standards maintained in
this hospital. The treatment and investigations will be done in the hospitals
own setup and any special cost of treatment will be borne by me, putting no
extra financial on the patient.

Dr. Arpan Mukhopadhyay,

M.D. (General Medicine) PGT,
Session: 2021-2024

Burdwan Medical College

 Undertaking by P.G. Residents

I. I have reviewed the clinical protocol and agree that it contains all the necessary
information to conduct the study. I will not begin the study until all necessary ethics
committee and regulatory approvals have been obtained.
II. I agree to conduct the study in accordance with the current protocol. I will not
implement any deviation from or changes of protocol without prior review and
documented approval/ favourable opinion from the Ethics Committee of the
amendment, except where necessary to eliminate an immediate hazard to the trial
subjects or when the change(s) involved are only logistical or administrative in nature.
III. I agree to personally conduct and/ or supervise the clinical study at my site.
IV. I agree to inform all subjects, that the drugs are being used for investigational purposes
and I will ensure that the requirements relating to obtaining informed consent and
Ethics Committee review and approval specified in the GCP guidelines are met.
V. I agree to report to the institutional Ethics Committee all adverse experiences, that
occupy the course of the study in accordance with the regulatory and GCP guidelines.
VI. I have read and understood the information in the Investigator’s Brochure, including the
potential risks and side effects of the drug.
VII. I agree to ensure that all associates, colleagues and employees assisting in the conduct
of the study are suitably qualified and experienced and they have been informed about
their obligations in meeting their commitments in this study.
VIII. I agree to maintain adequate and accurate records and to make these records available
for audit/ inspection by the Ethics Committee. I will fully cooperate with any study
related audit conducted by the Ethics Committee.
IX. I agree to promptly report to the Ethics Committee all changes in the activities and all
unanticipated problems involving risk to human subjects or others.
X. I agree to inform all unexpected serious adverse events to the Ethics Committee within
seven days of their occurrence.
XI. I will maintain confidentiality of the identification of all participating study patients and
assure security and confidentiality of study data.
XII. I agree to comply with all other requirements, guidelines and statutory obligations as
applicable to Clinical Investigators participating in clinical study.
“A Study On The Correlation Of Serum Magnesium And
Hepatic Encephalopathy In Patients With Liver Cirrhosis In
A Tertiary Care Hospital In Eastern India”
To,

The Dean,

The West Bengal University of Health Sciences, Kolkata

Through proper channel

Sub: Application for approval of synopsis

Respected sir/ ma’am,

With due respect, I beg to state that I, Dr. Arpan Mukhopadhyay, First year post
graduate trainee, department of general medicine, Burdwan Medical College, Session
2021-2024 want to submit my synopsis under guidance of Prof. Saumik Datta (Professor,
Department of General Medicine, Burdwan Medical College and Hospital) for thesis work
for approval. My proposed topic is “A Study On The Correlation Of Serum Magnesium And
Hepatic Encephalopathy In Patients With Liver Cirrhosis In A Tertiary Care Hospital In
Eastern India”

I will be highly obliged if you kindly accept my application and do the needful.

Thanking you,

Yours sincerely,

Dr. Arpan Mukhopadhyay

Post Graduate Trainee

Department of General Medicine

Forwarded by:

Signature of Guide:

Signature of Head of the Department:

To,

The Principal,

Burdwan Medical College and Hospital,

The West Bengal University of Health Sciences, Kolkata

Through proper channel

Sub: Application for approval of synopsis

Respected sir/ ma’am,

With due respect, I beg to state that I, Dr. Arpan Mukhopadhyay, First year post
graduate trainee, department of general medicine, Burdwan Medical College,
Session 2021-2024 want to submit my synopsis under guidance of Prof. Saumik
Datta (Professor, Department of General Medicine, Burdwan Medical College and
Hospital) for thesis work for approval. My proposed topic is “A Study On The Correlation
Of Serum Magnesium And Hepatic Encephalopathy In Patients With Liver Cirrhosis In A
Tertiary Care Hospital In Eastern India”

I will be highly obliged if you kindly accept my application and do the needful.

Thanking you,
Yours sincerely,
Dr.Arpan Mukhopadhyay

Post Graduate Trainee,

Department of General Medicine

Forwarded by:

Signature of Guide:

Signature of Head of the Department: