| CTRI Number |
CTRI/2025/03/082339 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of safety of 3 drugs which are Rifampicin 600mg , Clarithromycin 500mg and Minocycline 200mg given monthly once under supervision in treatment of leprosy versus standard MDT drug regimen in treatment of leprosy.
|
|
Scientific Title of Study
|
Comparative efficacy and safety of Rifampicin, Minocycline and Clarithromycin monthly pulse regimen versus standard WHO multidrug regimen in leprosy A randomized controlled 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 Minu s kani |
| Designation |
Post graduate resident |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
dermatology department, A Block , room 03, Kalinga Institute of Medical Sciences, Patia, Bhubaeswar
KIIT Road , Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
09443345169 |
| Fax |
|
| Email |
minuskani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanta kumar kar |
| Designation |
Professor of department of dermatology |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
kalinga institute of medical sciences, patia, bhubaneswar
KIIT ROAD, BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9944217488 |
| Fax |
|
| Email |
hemanta.kar@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minu s kani |
| Designation |
Post graduate resident |
| Affiliation |
post graduate resident , Kalinga institute of medical sciences |
| Address |
Dermatology department , A block , room 03, first floor, kalinga institute of medical sciences, patia, bhubaneswar
KIIT Road , Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
09443345169 |
| Fax |
|
| Email |
minuskani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Minu S Kani , Dermatology depatment , A Block ,kalinga institute of medical sciences (KIMS), KIIT road, patia , bhubaneswar , odisha
|
|
|
Primary Sponsor
|
| Name |
Dr Minu S Kani |
| Address |
Dermatology department ,Kalinga institute of medical sciences, patia, bhubaneswar, Odisha |
| Type of Sponsor |
Other [self funded ] |
|
|
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 Minu s kani |
Kalinga Institute of Medical sciences |
Dermatology department , Block A
Room 04 , first floor,
Patia, Bhubaneswar, odisha
Khordha
ORISSA |
09443345169
minuskani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MDT REGIMEN |
Standard WHO MDT regimen comprising of 600mg Rifampicin, 300mg Clofazimine, 100mg of Dapsone on day 1 of every month, followed by 100mg of dapsone and 50mg of clofazimine on all other days of month for 6 months and 12 months in paucibacillary and multibacillary Hansen respectively |
| Intervention |
RCM REGIMEN |
RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) regimen for 6 months in paucibacillary and 12 months in multibacillary Hansen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All new cases fulfilling cardinal signs of leprosy and biopsy proven
patients above 18 years of age
|
|
| ExclusionCriteria |
| Details |
Patients on steroids and other immunosuppressive drugs
Pregnancy and lactation
Pure neuritic leprosy
Contraindications to the drugs in regimen.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) in treatment of pauci and multi bacillary hansen is equally efficacious as WHO MDT in treatment of leprosy |
patients are assessed at baseline , at 6 months and 12 months of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg & Minocycline 200mg (RCM) in treatment of pauci & multi bacillary hansen has more safety profile with less side effects when compared to daily WHO MDT in treatment of leprosy |
patients are assessed at baseline , 6 months & 12 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Leprosy, caused by Mycobacterium
leprae is a debilitating disease of skin and peripheral
nerves.
•Multidrug therapy comprising of Rifampicin, Clofazimine and Dapsone is the standard regimen in the treatment of leprosy •Although effective, MDT has various side effects
ranging from dapsone
hypersensitivity syndrome which can be
lethal to clofazimine induced pigmentation that can be cosmetically unappealing and may take
months to resolve. •The higher pill
burden also contributes to a decreased compliance •Although WHO MDT has significantly
reduced the prevalence of disease burden , the associated adverse effects
have impacted adherence, thus affecting overall treatment
outcome. Hence there is a need to consider alternative
regimens with a higher
safety profile to improve treatment efficacy and adherence. Thus, we are
introducing a regimen comprising of three
bactericidal drugs Rifampicin, Clarithromycin and Minocycline (RCM) administered
monthly once under supervision in treatment of newly diagnosed cases of
Leprosy.
|