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CTRI Number  CTRI/2024/11/076211 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence Of Bars Vitiligo in Patients attending Govt Nizamia General Hospital Charminar Hyderabad 
Scientific Title of Study   An Observational Study on the Prevalence Of Bars Vitiligo  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammed Maqbool Hussain 
Designation  Professor and HOD 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Department of Tahaffuzi Wa Samaji Tib Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad Telengana

Hyderabad
TELANGANA
500002
India 
Phone  9676832883  
Fax    
Email  maqboolahmar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammed Maqbool Hussain 
Designation  Professor and HOD 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Dept of Tahaffuzi Wa Samaji Tib Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad Telengana

Hyderabad
TELANGANA
500002
India 
Phone  9676832883  
Fax    
Email  maqboolahmar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammed Maqbool Hussain 
Designation  Professor and HOD 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  Dept of Tahaffuzi Wa Samaji Tib Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad Telengana

Hyderabad
TELANGANA
500002
India 
Phone  9676832883  
Fax    
Email  maqboolahmar@gmail.com  
 
Source of Monetary or Material Support  
Government Nizamia Tibbi College Charminar Hyderabad Telengana 500002 India 
 
Primary Sponsor  
Name  Government Nizamia Tibbi College 
Address  Government Nizamia Tibbi College Charminar Hyderabad Telengana 500002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Syed abdul Zahoor  Government Nizamia Tibbi College and General Hospital  room 101 opd skin room no 102 opd psm Government Nizamia Tibbi College and General Hospital
Hyderabad
TELANGANA 
9676832883

abdulzahoor313@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients with hypopigmentation of skin
patients with complaints of white patches over skin

 
 
ExclusionCriteria 
Details  patient who are not giving informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to know the prevalence of the disease  3months 
 
Secondary Outcome  
Outcome  TimePoints 
to educate the patients about the prevalence of the disease  3months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE OF THE TOPIC

An Observational Study On “THE PREVALENCE OF BARS(VITILIGO)”in Patients Attending Govt.Nizamia General Hospital,,Charminar,Hyderabad.

BRIEF RESUME OF THE INTENDED WORK

 

NEED OF THE STUDY :

 

Ø  The population prevalence of vitiligo ranges from 0.1%  to 2% and shows a wide variability among ethnic groups.The highest incidence of the condition has been recorded in Indians from Indian sub continent followed by mexico and japan

 

Ø  Vitiligo is reported more frequently in females than males , which may be the result of increased reporting rates in females due to greater social consequences in females affected by vitiligo.

 

 

Ø  However the majority of the vitiligo cases are reported during stages of active development .About 50% of cases presents before the age of 20 and nearly 70-80% before 30 years of age.Although no age is immune to vitiligo,the disease is very rarely observed at birth.

 

Ø  Accordingly,the worldwide prevalence of vitiligo ranges between 0.5 and 2%.The prevalence of vitiligo in India has been reported between 0.25% and 4% of dermatology outpatients across studies from India and upto 8.8% in Gujrat and Rajasthan16.

 

Ø   A number of studies have been conducted on the prevalence of vitiligo worldwide including india ,the prevalence of vitiligo is still the major public health problem in india.

 

Ø  In view of above facts I would like to conduct An Observational Study On “THE PREVALENCE OF BARS (VITILIGO)”in Patients Attending Govt. Nizamia General Hospital,,Charminar,Hyderabad.

 

INTRODUCTION :

 

Ø  Vitiligo is an autoimmune / acquired condition affecting 1% of the population world wide .Focal loss of melanocytes results in the development of patches of hypopigmentation.A positive family history  of vitiligo is relatively common in those with extensive disease and this type is also associated with other Autoimmune diseases,trauma and sunburn (through Kobner phenomenon) may precipitate the appearance of vitiligo .The pathogenesis is unclear and whilst melanocytes may be the target of cell mediated immune attack1 

 

 

REVIEW OF LITERATURE :-

 

UNANI  LITERATURE:

 

Ø  The Author of Makhzanul Hikmat” Hakeem Ghulam Jeelani Khan” stated that  Bars is a condition in which white spots arises on skin surface . These spots are primarily small in size and then increases gradually.Sometimes it may be due to

·       Neurogenic defect which leads to weakening of quwwate- e mughaiyara .

·       Idiopathic .

·       Hereditary.2

 

Ø  Abul Hasan Ahmed  Bin Tabri described in his book “Moalijat e Bukhratiya” that sometimes the lesion of Bars is smooth,shiny and soft to touch and it is because of Maddae raddiya (Morbid matter) that dearranged the Nutritional process of the effected site( zoof-e-quwwate jazeba).

In some cases the lesion of Bars is neither smooth nor shiny and soft . it is because of ghaleez rutobat (thick viscous matter)  at effected site

Sometimes the lesion is reddish because of the presence of blood in between the skin and the muscle .This condition is found before the blood is affected by Rutobat-e-Fasida3

 

Ø  Akbar Arzani distinguished  Bars from Beheq abyaz in his book “Tib e Akbar” that Behaq Abyaz doesn’t penetrate deep in the skin and it remains superficial .After pricking at the site of Beheq  abyaz  blood always comes out and hair at the site of beheq abyaz  never becomes white even after the disease becomes chronic . But in  Bars it penetrates deep in the skin and in most of the cases the hair at the site of Bars becomes white and the site of lesion doesn’t turn red on rubbing4.

 

Ø  Qamri described in his book “Ghina Muna “ quoting Yahya ibn Masuiyah that if the  white patches of bars turned red on rubbing it means lesion is new and can be treated easily and if the colour of the lesion remains unchanged it signifies that the disease is chronic and is difficult to treat5.

 

Ø  According to Raban Tabri in his famous book “Firdous ul Hikmat “  the causes of Bars are Fasad ud Dam ( Impairment of Blood) due to weakening of Quwwat-e-Hazima which leads to production of Fasid Blood ,

Burodat-e-Dam ( Coldness of blood) .If the causes of Fasad ud Dam are Burodat (Coldness) and Phlegm (Balgham) then it leads to bars(vitiligo)6.

 

Ø  Bars is caused by excessive accumulation of balgam e ghaleez in the blood and zoofe quwat-e-mughaiyara of skin7.

 

MODERN THEORY    

 

Ø  The word Vitiligo is derived from the greek word “vitilius”  meaning calf ( white patches of vitiligo resembles white patches of calf ) it is an acquired depigmentary disorders of skin which lacks melanocytes8.

 

Ø  It is an acquired sometimes familial condition,an auto immune disease in majority.Vitiligo is associated with other autoimmune diseases such as Thyroid disease ,Diabetes mellitus,Addisons disease and Pernicious anaemia .Pathogenesis of vitiligo is acomplex process involving  the melanocytes,epidermal keratinocytes,immune system and peripheral nervous system9.

 

 

Ø  Vitiligo usually begins since childhood or young adulthood with a peek onset between 10-30 years about half of the cases begins before the age of 20 .the prevalence ranges from 0.5 – 1%10.

 

Ø  This is a common skin disorder in which there is focal failure of pigmentation due to destruction of melanocytes that is thought to be mediated by immunological mechanism11.

 

 

Ø  It presents in childhood or early adult life with well demarcated macules of complete pigment loss .there is no history of preceding inflammation .patients are very susceptible to sun burn .lesions are often symmetrical and frequently involve  the face ,hands and genitalia.the hair can also get depigmented .Trauma may induce new lesions.Spontaneous repigmentation  can occur and often starts around hair follicles,giving a specked appearance.However repigmentation is rare if a lesion persisted for more than 1 year.The psychological consequences can be devastating,especially in Asians and black African people12.

 

 

ETIOLOGY:

 

 There are many theories of causation

1.Auto immune Theory (Immunological Theory). Vitiligo is associated with several circulating auto antibodies and other autoimmune disorders like Hashimoto’s thyroiditis,Dm etc.

 

2.Melanotoxic Theory: The autocytotoxic theory suggests that vitiligo may be form of cellular suicide in which intermediary metabolites of melanin selectively destroys pigment cells.

 

3.Neural theory: It is based on the observation that in some patients , vitiligo is confined to a portion of one side of the body i.e Segmental Vitiligo.

 

4.Melanocytorhagy: This theory proposes that vitiligo results from defective adhesion.

 

5.Convergance Theory: Available data suggests that vitiligo is multifactorial and may be the end result  of several different pathological  pathways8.

 

 

MORPHOLOGY:

 

Depigmented ,milky white  or hypopigmented (light colour) macules and patches that are sharply demarcated from the surrounding normal coloured skin typify the disease .The affected skin is otherwise normal except for a little erythema of patches on sun exposed regions  due to heightened sensitivity to sunlight .Hair within a patch may turn  white (Leukotrichia) margins of the patches may be hyper pigmented or hypopigmented or be normal in colour13.

 

TYPES :

 

Depending upon the number of lesions and site involved .it has been classified into

 

 1 .Localised Vitiligo :

(A) Focal Vitiligo : An isolated macule or a few macules limited in both size and number .it may be localized to skin or mucosa

 

(B) Segmental Vitiligo  :vitiligo macules are distributed along a dermatome.

 

2.Generalised Vitiligo :

 

(A)    Vitiligo vulgaris : the most common form of vitiligo in wich widespread macules are often     symmetrically placed over limbs and trunk.

 

    (B)Lip-Tip Vitiligo : Tips of fingers alone or with certain mucosal surfaces like lips,distal penis or nipples are involved.

 

(B)    Acrofacial Vitiligo : It involves face and distal digits.

 

(C)    Universal Vitiligo : Almost whole of the body is involved and only few small areas are spared8.

 

DIETARY RESTRICTIONS :

 

§  Milk and dairy products.

§  Aghziya Ghaliza.

§  Muwallid-i-Balgham Aghziya.15

 

DIFFERENTIAL DIAGNOSIS:-

 

Acquired :   

                1.Chemical Induced

                2.Halo Nevus

                3.Pityriasis Alba

                4.Idiopathic Gutate Hypomelanois

                5.Tinea Versicolor

 

Congenital:

                1.Albinism

                2.Piebaldism

                3.Nevus Depigmentosus

                4.Tuberous Sclerosis

                5.Nevus Anemicus8

 

 OBJECTIVES OF THE STUDY

 

1.     The Aim of this Study is to Measure the prevalence of BARS (Vitiligo) in GNGH ,Charminar,Hyderabad.

2.     To Educate the patient Regarding the Disease Spreading through family predisposing and dietary factors.

 

 

MATERIAL AND METHODS

 

v  Source of Data:-

·       Patients Attending at OP Dept of Skin & Cosmetology ,Govt. Nizamia General Hospital, Charminar, Hyderabad, Telangana.

 

v  Method of Collection of Data:-

·       Data will be Collected by using a predesigned structured Questionnaire which contains open ended Questions.

v  Inclusion Criteria:-

 

·       Age Group : All

·       Sex: Both

 

v  Exclusion Criteria:-  

 

·       Patient who are not giving informed consent.

                                                                    

 

v  Parameters of Study:-  

                               

                                Subjective Parameters:

·       Patients complaining of hypo-pigmentation and white patches.

                                Objective Parameters:

·       The diagnosis will be based on the Inspection ,history,clinical examination

·       Interaction by using predesign structured questionnaire.

·       Basic investigations if required.

 

 

v  Study Design:-

·       observational study

 

v  Sample Size:-

·       All Available Patients attending at OP Dept of Skin & Cosmetology, Govt Nizamia General Hospital during the period of study.

 

v  Duration of Protocol:-

·       12 months

 

v  Procedure of Study:

·       It will be based on History taking and clinical features and Interaction with patient

 

v  Evaluation:-

·       Data will be Analyzed statistically

 

 

Does the study require any investigations to be conducted on patients or Human Being or Animals

No

Has Ethical clearance been obtained from your institution in case of 7.3

 

 

 

List of references

 

1.     Walker BR , Colledge NR,Ralston SH,Penman ID,Davidson’s principles and practice of medicine,22nd Edition,Edinburgh;Newyork;Churchill Livingstone/Elsevier;2014,page:1295.

 

2.       Jeelani H Ghulam,Makhzanul Hikmat,New Delhi,Aijaz publication,page :1021.

 

 

3.     Tabri A , Moalijat-e-Bukhratiyah,Vol-2,CCRIUM,New Delhi,page :199.

 

4.      Arzani M Akbar ,Tib-e-Akbar ,translated by Hakeem Mohd Hasan ,Idara Kitabul Shifa, page:735

 

5.      Qamri A,Ghina Muna ,New Delhi,CCRIUM,2008,page:458.

 

6        Tabri R, ,Firdous ul Hikmat,page :294.

 

 

7       Jurjani A Hassan ,Zakheere Khwarzim Shahi,translated  by Hakeem Hadi hussain khan,New Delhi ,Idare Kitabul Shifa ,page:18.

 

8       Thappa DM ,Textbook of Dermatology,venerology and Leprology,3rd edition, London ;Elsevier Health sciences APAC;2013,page :196,197,198.

 

 

9      Golwalla Shahrukh A Nadkar Milind Y Golwalla Aspi F,Golwalla medicine for students,21st edition,Jaypee brothers  medical publisher(P)Ltd;2014,page:942.

 

10    James WD,Berger TG,Elston DM,Andrews diseases of skin clinical dermatology,11th edition,Elsevier Health sciences;2011,page:855,856.

 

 

11   Marks R,Roxburgh’s common skin diseases,17th edition,CRC press 2003,page:297.

 

12    Kumar PJ and Clark ML,Kumar and Clark’s clinical medicine,7th edition,Edenburgh;Elsevier,page:1264.

 

 

13   Khopkar U,An illustrated handbook of skin diseases and  sexually transmitted 

infections,page:141.

 

14   Ferri FF, Studdiford JS,Tully AS,Ferri’sFast Facts in Dermatology,Elsiever Health Sciences;2010 ,page:392,393.

 

15   Standard Unani Treatment Guidelines For Common Diseases,Vol-I ,CCRUM-2014, Pg 181.

 

16   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6362747/#:~:text=The%20prevalence%20of%20vitiligo%20in,8.8%25%20in%20Gujarat%20and%20Rajasthan.

 

 

 

 

 
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