| CTRI Number |
CTRI/2024/05/068096 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Neuropathic pain component in skin pain in atopic dermatitis patients and its impact on patients quality of life |
|
Scientific Title of Study
|
Neuropathic pain component in skin pain and its impact on patients with atopic dermatitis: A cross-sectional study |
| 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 Aman Jangra |
| Designation |
PG resident |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care UCMS and GTB Hospital Dilshad Garden New Delhi
East
DELHI
110092
India |
| Phone |
8800270975 |
| Fax |
|
| Email |
Dramanjangra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aman Jangra |
| Designation |
PG resident |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care UCMS and GTB Hospital Dilshad Garden New Delhi
East
DELHI
110092
India |
| Phone |
8800270975 |
| Fax |
|
| Email |
Dramanjangra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor |
| Affiliation |
University college of medical sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
University college of medical sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
Profashoksaxena2@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital Dilshad Garden New Delhi India 110095 |
|
|
Primary Sponsor
|
| Name |
University college of medical sciences and GTB Hospital |
| Address |
University college of medical sciences and GTB Hospital, Dilshad Garden,New Delhi,110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Aman Jangra |
University college Of medical sciences and GTB Hospital |
Department of Anaesthesiology and Critical Care, University College of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden,New Delhi,110095
East
DELHI |
8800270975
Dramanjangra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-HUMAN RESEARCH (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 12 to 70 years with diagnosis of Atopic dermatitis |
|
| ExclusionCriteria |
| Details |
1 Patients of AD associated with comorbidities like Diabetes Hypertension etc
2 Patients of AD not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neuropathic pain in atopic dermatitis patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess & evaluate the severity of itching using NRS itch score & patient oriented eczema measure POEM score
2 To assess & evaluate the impact of skin pain on patients sleep using NRS Sleep score
3 To assess & evaluate the impact of skin pain on patients quality of life using SF12 questionnaire score
4 To correlate DN4 questionnaire score & SF12 questionnaire score
5 To correlate the relevant NPSI questionnaire score & SF12 questionnaire score
6 To correlate DN4 score & patient oriented eczema measure POEM
|
Baseline |
|
|
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)
|
10/06/2024 |
| 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="3"
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
|
Atopic dermatitis (AD) is a chronic, inflammatory skin disorder characterized by eczema, dry skin, and intense pruritus. It affects both children (20%) and adults (10%), especially in developed countries. Although the hallmark symptom of atopic dermatitis is “itchingâ€, the prominence of “skin pain†in AD emerges as a noteworthy but less explored symptom in atopic dermatitis. At times pain and itch appear at the same time making it difficult to differentiate their clinical impacts. A study showed that half of the AD patient (50.4%) were clearly able to differentiate between itching and skin pain. In AD pain is usually associated with scratching and fissures or red inflammed skin. Hence the present study has been designed to explore the presence of neuropathic component in patients of atopic dermatitis presenting with skin pain. On detailed literature search we could not retrieve any study for assessment and evaluation of neuropathic pain component in patients of AD experiencing skin pain. Also we could not retrieve any study on utilization of DN4 questionnaire score, NPSI questionnaire score and PDQ questionnaire score for assessment and evaluation of neuropathic pain component in overall skin pain in patients of AD.
|