Home » Trials » SLCTR/2014/028
Randomized, double blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis
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SLCTR Registration Number
SLCTR/2014/028
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Randomized, double blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis
Public Title of Trial
Treatment for leishmaniasis
Disease or Health Condition(s) Studied
Cutaneous leishmaniasis
Scientific Acronym
None
Public Acronym
None
Brief title
Intralesional metronidazole in cutaneous leishmaniasis
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the efficacy and safety of intralesional metronidazole compared to intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms.
Arm 1 (intervention arm) will receive intralesional metronidazole 0.2-4ml per lesion depending on the size of the lesion, weekly until cure or maximum of 10 (ten) injections
Arm 2 (control arm) will receive intralesional stibogluconate 0.2-4ml per lesion depending on the size of the lesion, weekly until cure or maximum of 10 (ten) injections
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[
|
Secondary outcome(s)
|
1.
|
[ Every 3 months from clinical cure for a total of 12 months ] |
Target number/sample size
150 (75 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-11-01
Anticipated end date
2015-11-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Funding approved by FAIRMED Foundation- SLMA Research Grant in Neglected Tropical Diseases- 2014
Regulatory approvals
Status
Approved
Date of Approval
2014-08-19
Approval number
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Ranthilaka R. Ranawaka
Consultant Dermatologist
Base Hospital Homagama, Homagama
0112855200
0718186148
ranthilaka37@yahoo.com
Contact Person for Public Queries
Ranthilaka R. Ranawaka
Consultant Dermatologist
Base Hospital Homagama, Homagama
0112855200
0718186148
ranthilaka37@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
