| CTRI Number |
CTRI/2025/11/097286 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Sensory Loss on Face and Extremities among Adults with Different Types of Leprosy in Delhi |
|
Scientific Title of Study
|
PREVALENCE OF SENSORY LOSS ON FACE AND EXTREMITIES AMONG ADULTS WITH DIFFERENT TYPES OF LEPROSY IN DELHI: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 |
Manushri Parmar |
| Designation |
Student |
| Affiliation |
Amity University, Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09548400083 |
| Fax |
0120-2431870 |
| Email |
manushriparmar10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity University, Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09999600611 |
| Fax |
0120-2431870 |
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity University, Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09999600611 |
| Fax |
0120-2431870 |
| Email |
ajain@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA |
|
|
Primary Sponsor
|
| Name |
Manushri Parmar |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sheetal Rawat |
The Leprosy Mission Hospital |
Road Number 69, Nand Nagri, Dilshad Garden, Delhi
East
DELHI |
9389723767
0120-2431870
sheetalrawat14.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NTCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A30||Leprosy [Hansens disease], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Leprosy with microbiological or clinical diagnosis.
2.Age 18 or above.
3. Willingness to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with diabetes.
2. History of recent trauma or sugery on limbs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of sensory loss on face and extremities among adults with different types of leprosy in Delhi. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Prevalence of ulcer site in leprosy. |
At baseline |
| 2.Association between sensory loss & ulcer severity |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
22/12/2025 |
| 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="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
|
This synopsis outlines a cross-sectional study titled "Prevalence of sensory loss on face and extremities among adults with different types of leprosy in Delhi: A Cross-Sectional Study". This study aims to determine the prevalence and types of sensory loss affecting the face and extremities among adults with different types of leprosy in Delhi, a region reporting 1,188 leprosy cases in 2023. It will also explore the prevalence and site distribution of ulcers and examine the association between sensory loss and ulcer severity to enhance early detection and preventive rehabilitation strategies.
Methodology includes: Study Design: A cross-sectional study with a sample size of 300 participants selected through cluster sampling.
Population: Adults aged 18 years and above, clinically or microbiologically diagnosed with leprosy. Individuals with diabetes or a recent history of trauma or surgery to the limbs will be excluded.
Outcome measures: Sensory testing using standardized methods and evaluation using WHO disability grading and Ulcer grading Scale.
Analysis: Data will be analyzed using Microsoft Excel and R software (version 3.6.1). Descriptive statistics will summarize demographic and clinical characteristics, while Chi-square tests and univariate logistic regression will assess the association between sensory loss and ulcer formation.
The findings are expected to provide region-specific data to guide early identification of high-risk patients, contributing to rehabilitation planning, disability prevention, and long-term patient monitoring in leprosy care. |