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CTRI Number  CTRI/2021/01/030228 [Registered on: 04/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to evaluate the characteristics of the smallest blood vessels present in the nail fold of healthy volunteers  
Scientific Title of Study   “Nailfold Capillaroscopy in healthy volunteers - Observational Study”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gorasiya Amitkumar Rameshbhai 
Designation  Residents Doctor First Year Dermatology and VD Sir T Hospital Bhavnagar 
Affiliation  Sir T Hospital Bhavnagar Government Medical College Bhavnagar 
Address  Room No 115 First Floor Skin Opd ,Sir-T Hospital Bhavnagar,Gujarat Bhavnagar Gujarat- 364001 India
Room No 115 First Floor Skin Opd ,Sir-T Hospital Bhavnagar,Gujarat Bhavnagar Gujarat- 364001 India
Bhavnagar
GUJARAT
364001
India 
Phone  8140474781  
Fax    
Email  a.r.gorasiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr hita maheta 
Designation  Head of department dermatology and VD sir t hospital Bhavnagar 
Affiliation  Sir t hospital medical College Bhavnagar 
Address  115 first floor skin opd ,sir-T hospital bhavnagar,gujrat Bhavnagar GUJARAT 364001 India

Bhavnagar
GUJARAT
364001
India 
Phone  9429503188  
Fax    
Email  hitamehta88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AMITKUMAR GORASIYA 
Designation  Residents doctor first year dermatology and VD sir t hospital Bhavnagar 
Affiliation  Sir t hospital medical College Bhavnagar 
Address  Room No 115 First Floor Skin Opd ,Sir-T Hospital Bhavnagar,Gujarat Bhavnagar Gujarat- 364001 India

Bhavnagar
GUJARAT
364001
India 
Phone  8140474781  
Fax    
Email  a.r.gorasiya@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology,Sir-T Hospital Bhavnagar,Gujarat Bhavnagar Gujarat- 364001 India 
 
Primary Sponsor  
Name  Dr Gorasiya Amitkumar Rameshbhai 
Address  208 Fresher Hostel Sir T Hospital Bhavnagar 
Type of Sponsor  Other [Self] 
 
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 
Gorasiya amitkumar Rameshbhai  Sir-T hospital,bhavnagar.  Room no 115 OPD of Dermatology,Venereology& Leprosy department at Sir-T hospital,bhavnagar.
Bhavnagar
GUJARAT 
8140474781

a.r.gorasiya@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee government medical College bhavangar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nill  Nill 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Normal people 
 
ExclusionCriteria 
Details  Pregnant or lactating women
Suffering from other nail conditions (e.g., psoriasis) which might interfere in the interpretation of results
Use of nail paint, nail acrylic or any cosmetic on the nail. Patient suffering from hypertension or other cardiac co-morbidities Preexisting disease that affects vascular architecture like Raynauds Phenomenon, Systemic Sclerosis, SLE ad other connective tissue diseases.
Patients with a history of Smoking or Trauma in the periungual fold. Patients with onychophagia, onychotillomania, with any other nail disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes if nailfold capillaries will be observed via capillaroscope in normal people and will be seen according to the following parameters
Dilated/Giant capillaries
Neoangiogenesis/bushy capillaries
Meandering capillaries
Tortuous capillaries
Avascular zones
Haemorrhages
Capillaries Visibility of the subpapillar venous plexus  
Once 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the baseline parameters in nailfold capillaroscopy so that the normal and abnormal change in NFC can be differentiated and its association with the other disease can be made.
Standardised common different in both sex and age group
 
Once 
 
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)   29/03/2021 
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="0"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Title "Nailfold Capillaroscopy in normal people - Observational Study"

Introduction & review of LiteratureNailfold capillaroscopy is reproducible, noninvasive, painless, and inexpensive technique for studying proximal nailfold (PNF) capillaries 

Nailfold capillaroscopy (NFC) is used in peripheral microcirculation ,primary and secondary raynaud’s phenomenon, systemic sclerosis , diabetics and hypertensive vasculopathy

The interpretation of NFC data is restricted by the paucity of studies in normal individuals.

NFC findings may be influenced by age, ethnicity, geographic region, inter-observer variation and differences in skin transparency (owing to skin pigmentation, hyperkeratosis, injuries, edema, etc.)
Research Question
What are the nailfold capillaroscopy findings in normal people?
Abnormal Nailfold Capillaroscopy finding in normal people
What is Differences in nail fold capillaries finding in different age-group and sex?

Aim/Goal To study the Nailfold Capillaries pattern in normal people
Objectives:
Primary: 
 to describe the morphological characteristics of nail fold capillaries in normal people
Secondary: 
To assess the baseline parameters in nailfold capillaroscopy so that the normal and abnormal change in NFC can be differentiated and it’s association with the other disease can be made.
Standardised common different in both sex and age group
Study design/typeThis will be an Observational, cross-sectional study
Study populationHealthy individual accompanying patients in dermatology opd , hospital staff (medical ,paramedical, administrative, supporting staff) undergraduate posted in department of dermatology
Sample size 100 
Study duration 12month
Study site. OPD of Dermatology,Venereology& Leprosy department at Sir-T
hospital,bhavnagar.

Study procedures Nailfold Capillaroscope – NFC will be performed on all 10 fingers.
Instrument to used – Dermoscope it will be connected to a computer. The images will be taken and recorded on the same device.
Method - This observational, analytical study will be conducted in Department of Dermatology sir t hospital (medical College) bhavangar Gujarat India
healthy individual accomplainig patients in dermatological department hospital staff (medical ,paramedical, adminstrative, supporting staff) undergraduate posted in dermatology department
Individuals are selected as per Convenience sampling and Inclusion and exclusion criteria will be applie examinationn of all 10 nails was performed in all study subjects.
Each volunteer was made to sit comfortably at an ambient Room temperature for 15 min and then subjected to a detailed NFC on all 10 fingernails with the hands placed on a dull non-refractile surface at the level of heart. The polarizing dermatoscop (immersion oil). NFC was performed by a single observer (AR) at higher magnification (100 X) for assessing the detailed morphology of the capillariesThe images were stored, processed and interpreted by observers
Inclusion criteria : 
Normal people. 
Age group 20-60 years
Exclusion criteria : 
 Pregnant or lactating women
FBS > 126 according to ADA guidelines for diabetics OR any past history of diabetes
Suffering from other nail conditions (e.g., psoriasis) which might interfere in the interpretation of results
Patient on with any drug history pertaining to cause vascular changes like vasodilators etc.
Use of nail paint, nail acrylic or any cosmetic on the nail.
Patient suffering from hypertension or other cardiac co-morbidities
 Pre existing disease that affects vascular architecture like Raynaud’s Phenomenon, Systemic Sclerosis, SLE ad other connective tissue diseases.
Patients with a history of Smoking or Trauma in the periungual fold.
Patients with onychophagia, onychotillomania , with any other nail disease

Outcome variablesCapillaroscopic Findings related to morphology and arrangement of vessles as well as any new parameters will be looked for and its further comparison and correlation will be done (its Dummy tables available in ppt). The presence or absence of the following parameters will be recorded:-
 
Dilated/Giant capillaries - width of the capillary >2 times or >10 times the normal, respectively
Neoangiogenesis/bushy capillaries - small, multiple buds originating from the distal loop
Meandering capillaries - limbs crossed upon themselves several times
Tortuous capillaries - capillary limb curled but not crossing over
 Avascular zones - absence of two or more adjacent capillaries from the distal‑most row 
 Haemorrhages - as the hemosiderin deposit, caused by the rupture of one or more capillaries. 
Bizarre Capillaries - atypical morphology not conforming to the predefined morphologies 
 Visibility of the subpapillar venous plexus - a network of larger vessels with respect to the capillaries. 
presence of the parameter was determined accordingly. 0: not visible 1: doubtful or limited visibility 2: Plexus visible in certain areas 3: Fully visible in large areas 
Capillary drop out - absence of capillary Loop
Statistical methodsData analysis plan 
Studied data will be analysed and compiled in master chart.
After tabulation of data,statistical analysis will be done.
The categorical variable will be analysed by number,percentage,frequency.
Chi-square will be applied wherever required

 
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