| CTRI Number |
CTRI/2023/09/057371 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of nail microcirculation changes in patients with chronic kidney disease
|
|
Scientific Title of Study
|
Study of nailfold capillaroscopy changes in patients with chronic kidney disease
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Jangid |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college Datta Meghe institute of higher education and research |
| Address |
department of Dermatology Venereology and Leprosy d block room no 114
Wardha
MAHARASHTRA
442004
India |
| Phone |
08956280444 |
| Fax |
|
| Email |
shivanijangid16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhushan Madke |
| Designation |
Head of department and professor |
| Affiliation |
Jawaharlal Nehru medical college Datta Meghe institute of higher education and research |
| Address |
department of Dermatology Venereology and Leprosy d block room no 114
Wardha
MAHARASHTRA
442004
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Jangid |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college Datta Meghe institute of higher education and research |
| Address |
department of Dermatology Venereology and Leprosy d block room no 114
SAWANGI (MEGHE) , WARDHA
Wardha
MAHARASHTRA
442004
India |
| Phone |
8956280444 |
| Fax |
|
| Email |
shivanijangid16@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACHARYA VINOBHA BHAVE RURAL HOSPITAL , DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH , SAWANGI (MEGHE ), WARDHA |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Jangid |
ACHARYA VINOBHA BHAVE RURAL HOSPITAL |
DEPARTMENT OF DERMATOLOGY , VENEREOLOGY AND LEPROSY , OPD NO : 114
Wardha
MAHARASHTRA |
8956280444
shivanijangid16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| datta meghe institute of higher education & research iINSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L609||Nail disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with chronic renal disease (stage 1 -5 ) above 18 years of age irrespective of sex.
Control group of patients without any underlying renal disease above 18 years of age irrespective of sex.
Patients willing to participate.
|
|
| ExclusionCriteria |
| Details |
Damage to finger in recent times.
Chemicals which may affect the quality of investigation of the fingers .
Patients having any autoimmune disease .
Patients have any underlying systemic disease known to affect digital microcirculation.
Patients with infective endocarditis , other systemic diseases like cardiac / hepatic disease, psoriasis, lichen planus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the various microvascular changes seen in nailfold capillaroscopy done in patients with chronic renal disease compared to healthy volunteers without any renal disease.
Outcome will be assessed based on MDAD criteria and association with laboratory parameters
|
BASELINE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the various microvascular changes seen in nailfold capillaroscopy done in patients with chronic renal disease compared to healthy volunteers without any renal disease.
|
baseline
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
18/09/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will help us in finding out the various microvascular changes
seen on nailfold capillaroscopy in patients of chronic kidney disease (stages
1-5 ) with their correlation with underlying etiology and renal function tests
as compared to patients without any underlying renal disease. |