| CTRI Number |
CTRI/2022/03/041539 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
28/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative Observation Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Cytokines in Type 1 Leprosy Reactions |
|
Scientific Title of Study
|
Study on levels of the Th17 and Treg pathway cytokines in Type 1 leprosy reactions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Daabas |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 74, Department of Dermatology, ABVIMS and Dr RML Hospital,
Baba Kharak Singh Road, Connaught Place, New Delhi
North West
DELHI
110001
India |
| Phone |
8700552041 |
| Fax |
|
| Email |
ssdabass@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananta Khurana |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 109, Department of Dermatology, ABVIMS and Dr RML Hospital,
Baba Kharak Singh Road, Connaught Place, New Delhi
North West
DELHI
110001
India |
| Phone |
8700552041 |
| Fax |
|
| Email |
drananta2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti Daabas |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 74, Department of Dermatology,ABVIMS and Dr RML Hospital,
Baba Kharak Singh Road, Connaught Place, New Delhi
North West
DELHI
110001
India |
| Phone |
8700552041 |
| Fax |
|
| Email |
ssdabass@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital and |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS and Dr RML Hospital, Baba Kharak Singh Road, Connaught Place, New Delhi, 110001 |
| 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 Srishti Dabas |
Dr Ram Manohar Lohia Hospital |
Department of Dermatology; Baba Kharak Singh Road, Connaught Place, New Delhi
Central
DELHI |
8700552041
ssdabass@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A308||Other forms of leprosy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Patients of either sex with Untreated recent Type 1 leprosy reaction, irrespective of MDT status
2.Presence of skin signs of Type 1 Leprosy reaction, with or without neuritis/ nerve function impairment
|
|
| ExclusionCriteria |
| Details |
Those already on treatment for Type 1 reactionÂÂ
<18 Years of age
Immunosuppressed patients- by way of disease or drugs
Pregnancy and lactating females
Presence of any other chronic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Levels of cytokine of Th 17 and Treg pathway in skin and blood of patients presenting with Type 1 leprosy reactions |
Baeline and after resolution of reaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure levels of cytokines of Th17 and Treg pathway in non reactional leprosy patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/04/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To measure the levels of cytokines of Th17 and Treg pathway in skin and blood of patients presenting with type 1 leprosy reactions. To compare with levels in non reactional leprosy patients To reassess the levels of the cytokines following resolution of the reaction |