| CTRI Number |
CTRI/2024/10/075228 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Determine the Side Effects of Drugs Prescribed for Leprosy Treatment |
|
Scientific Title of Study
|
Evaluation of Adverse Drug Reaction Profile of Drugs Prescribed for the Treatment of Leprosy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1314-3773 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Chandra C V |
| Designation |
Post Graduate (PG) Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Raipur |
| Address |
School of Public Health (SPH), All India Institute of Medical Sciences (AIIMS), Great Eastern (GE) Road, Tatibandh, Raipur (492099), Chhattisgarh, India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9886377505 |
| Fax |
|
| Email |
ravichandracv2995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Rewaram Gaikwad |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Raipur |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881725 |
| Fax |
|
| Email |
nitingaikwad2707@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyaki Ganguly |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Raipur |
| Address |
Department of Dermatology, All India Institute of Medical Sciences (AIIMS), Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7639471456 |
| Fax |
|
| Email |
satyakiganguly@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Great Eastern (GE) Road, Tatibandh, Raipur (492099), Chhattisgarh, India |
|
|
Primary Sponsor
|
| Name |
Dr Ravi Chandra C V |
| Address |
School of Public Health (SPH), All India Institute of Medical Sciences (AIIMS), Great Eastern (GE) Road, Tatibandh, Raipur (492099), Chhattisgarh, India |
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
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 Ravi Chandra C V |
All India Institute of Medical Sciences (AIIMS), Raipur |
Department of Dermatology, All India Institute of Medical Sciences (AIIMS), Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
9886377505
ravichandracv2995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (IEC), All India Institute of Medical Sciences (AIIMS), Raipur, Chhattisgarh |
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed leprosy subjects irrespective of age, gender and co-morbidities. 2. Patients completed or undergoing multidrug therapy or alternative drug regimens for paucibacillary (PB) and multibacillary (MB) leprosy. 3. Patients receiving treatment for the management of complications of leprosy. 4. Subjects willing to participate and providing the written informed consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate and not furnishing the required informed consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction profile (prevalence, causality, severity and preventability of drug reactions) of prescribed medications in the treatment of leprosy. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Medication adherence to multidrug therapy (MDT) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/10/2024 |
| 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="0"
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
|
The research aims to evaluate the side effects of medications prescribed for the treatment of Leprosy, also known as Hansen’s Disease, a chronic bacterial infectious disease affecting the skin, nerves, and respiratory tract, primarily caused by Mycobacterium Leprae or Mycobacterium Lepromatosis. Leprosy remains a public health concern, despite being declared ‘eliminated’ in India (2005), the country still accounts for over half of the world’s new leprosy cases, with the highest prevalence in Chhattisgarh. The introduction of multidrug therapy (MDT) by the World Health Organization (WHO) in 1981 has been effective in reducing the prevalence of leprosy, but the adverse drug reactions (ADRs) associated with the treatment remain a significant issue. These reactions can range from mild to severe and may lead patients either to stop or alter their treatment without consulting healthcare providers, potentially hindering disease management and contributing to drug resistance. The study focuses on assessing the prevalence, causality, severity, and preventability of adverse drug reactions linked to leprosy medications and evaluates medication adherence to multidrug therapy among leprosy patients, as nonadherence can result in treatment failure and contribute to the further transmission of the disease. The methodology involves a cross-sectional study design with a minimum sample size of 35 leprosy patients, employing enumerative sampling techniques, conducted over a year at the All India Institute of Medical Sciences (AIIMS) Raipur, focusing on patients availing the dermatology outpatient and inpatient services. The study aims to improve leprosy treatment by providing insights into optimizing medication protocols and enhancing patient adherence, thereby contributing to global leprosy elimination efforts. |