To

The Chairman

Institutional Ethical Committee,

Govt. Medical College Jammu.

Subject: Permission for ethical approval for the proposed study.

Dear Sir,

With due respect this is to submit that my thesis topic is “A TERTIARY HOSPITAL
BASED CASE CONTROL STUDY TO ASSESS THE PREVALENCE OF METABOLIC
SYNDROME IN VITILIGO PATIENTS” MY Guide is Dr.Naina kala Dogra
Associate Proffesor Depatment of Dermatology, Venereology and Leprology
GMC Jammu and my co–guide is Dr Devraj Dogra professor and head,
department of Dermatology,Venereology and Leprology SMGS hospital. kindly
issue IEC clearance certificate in my favour.

Thanking you

Yours sincerely

DR. Fayaz Ahmad Tak

Pg 2nd year

Postgraduate Department of Dermatology, Venereology and Leprology.

Gmc Jammu

4th November 2019

Mob.No 9419065338
Fayaztak32@gmail.com
To

The Member Secretary

Institutional Ethical Committee

Govt. Medical College Jammu.

Subject: Submission of study protocol for ethical clearance.

Respected Sir/Madam,

I, Dr. Fayaz ahmad tak second year Postgraduate in the Department of

Dermatology,Venereology and Leprology SMGS hospital GMC Jammu, wish to
state that the topic of my thesis is “Research topic TERTIARY HOSPITAL BASED
CASE CONTROL STUDY TO ASSESS THE PREVALENCE OF METABOLIC
SYNDROME IN VITILIGO PATIENTS “SYNDROME IN VITILIGO PATIENTS” MY
Guide is Dr.Naina kala Dogra Associate Proffesor Depatment of Dermatology,
Venereology and Leprology SMGS Hospital, GMC Jammu and my co–guide is
Dr Devraj Dogra professor and head, department of Dermatology,Venereology
and Leprology SMGS hospital. Kindly issue IEC clearance certificate in my
favour.

Thanking you

Yours sincerely

Dr. Fayaz Ahmad Tak

PG second year
Postgraduate Dept. of Dermatology,Venereology and Leprology
SMS Hospital GMC Jammu

4th of November, 2019

Mob. No 9419065338
Email- fayaztak32@gmail.com
Abstract

Introduction:
Bronchial asthma is a common chronic disease of the respiratory system that affects
approximately 300 million people worldwide (GINA).asthma is a chronic lung disease
characterized by airway asthma is a chronic lung disease characterized by airway
inflammation and hyperresponsiveness of airway smooth muscles .

The mainstay of management is a beta agonist and corticosteroid inhaler. Low blood levels
and low dietary intake of magnesium contribute to the development of asthma.

Nebulised beta agonist in asthmatic is considered to be the first choice of bronchodilator

therapy .some asthmatic patients poorly respond to beta agonist therapy. they also do not
respond to combination therapy with nebulised beta agonist , anticholinergic , locally acting
or intravenous steroids . for such poor responders magnesium sulphate administered either iv
or nebulised as isotonic solution is of help to achieve rapid bronchodilation .

Intravenous magnesium sulphate can relax smooth muscles and hence cause bronchodilation
by competing with calcium at calcium mediated smooth muscle binding sites .
It has been shown there were high prevelance of hypomagnesemia in stable asthmatics with
higher incidence of acute asthma attacks and hospitalization . hence related significantly with
severity of asthma.

Aims and Objectives:

SERUM MAGNESIUM IN BRONCHIAL ASTHMA AND ITS
CORRELATION WITH ITS ACUTE EXACERBATION
Settings and design:
Observational and prospectivestudy.

Material and Methods

• Detail History taking & clinical examination
• Investigations after taking written informed consent
• Patients will be explained about the surgeries
• Intraoperatively careful note be made about
 Time latent for the procedure
 Documentation of any complication during procedure
 Post operative period will be divided into immediate or in hospital
stay, following data will be collected,
 Drain Removal if put
 Post Operative hospital stay
 Any complication if occured
• Patients of both groups will be regularly followed regularly upto 3
months after discharge from hospital.
 Standard Operating Procedure
Institutional Ethics Committee, GMC Jammu
Version – 1.0, dated: 25-June-2013
Annexure -1

Proforma to be submitted to the GMC Institute Ethics committee

A TERTIARY HOSPITAL BASED CASE CONTROL STUDY TO
ASSESS THE PREVALENCE OF METABOLIC SYNDROME IN
1. Title of the Project VITILIGO PATIENTS

Dr. Fayaz ahmad tak, PG 2nd year, Postgraduate Department of

Dermatology, Venereology and Leprology, SMGS Hospital
Govt. Medical College, Jammu.
2. Name Of the chief
Investigator & department.

Dr. Naina kala dogra, Associate Professor, Postgraduate

Department of Dermatology,Venereology and
Leprology,SMGS Hospital, GMC Jammu.
3. Name of guide&
department
4. Source of funding Nil
5. Objectives of study 1. To study the prevalence of metabolic syndrome in viti-

-ligo patients.

2. To compare the prevalence of metabolic syndrome in

Vitiligo patients with control population

3. To study the prevalence of metabolic syndrome with

the severity of vitiligo.

6. Justification for conduct of Vitiligo affects 1-2% of population.There is still debate about
the relationship between vitiligo and metabolic syndrome. If the
existence of metabolic disturbance in vitiligo is proved, the
development of atherosclerosis and other cardiovascular
diseases can be expected, which will change the future
Study management of vitiligo patients.
7. Methodology – it should A Tertiary Hospital based case control study will be conducted
provide detail of number of over a period of one year including patients of vitiligo with :
patients, inclusion criteria, • Depigmentation greater than 10%.
exclusion criteria, control(s), • Age more than 18 years(both cases and controls)
study design • No systemic or local therapy 3 months before the
 begining of the study.

Exclude those:
• Age less than 18 years
• Other skin diseases associated with metabolic syndrome
like psoriasis.
• Patients with hypertension,diabetes milletus,thyroid
diseases,emotional or physical stress,atherosclerotic
vascular disease,infections,malignancy,using
corticosteroids.

8. Ethical issue involved in Nil

Study
9. Cost involved Nil
10. Permission from Drug NA
Controller General of India, if
applicable
11. Whether consent form in Yes
local language is enclosed
12. Conflict of interest for any Nil
other investigator, if any

Signature of investigator