Comparison of efficacy of intramuscular meglumine antimoniate plus oral allopurinol with intramuscular meglumine antimoniate alone in treatment of cutaneous leishmaniasis
Comparison of efficacy of intramuscular meglumine antimoniate plus oral allopurinol with intramuscular meglumine antimoniate alone in treatment of cutaneous leishmaniasis
Design
Clinical trial which is parallel group, double blind, randomized, phase 3 trial.
Settings and conduct
Dermatology Department Combined military hospital Quetta
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients with biopsy proven leishmaniasis plus has lesion(s) located in sites not compatible with local treatment for example on or around eyes
lesions in which scaring would be disfiguring like on face
lesions that will have difficulting in healing like on lower limb or
lesion ≥4 cm
lesion with sporotrichoid spread
Exclusion criteria:patients allergic to antimonials
pregnant and breast feeding women
patients having mucosal, mucocutaneous or visceral leishmaniasis
Patients with comorbidity (diabetes, hypertension,chronic liver disease,chronic kidney disease) and/or immunosuppression
Patients with baseline ECG abnormalities/
Intervention groups
Intervention group A: Patients were given drug via Intramuscular route injection meglumine antimoniate plus oral allopurinol. Intramuscular meglumine antimoniate was given in dose of 15mg/kg intramuscular if volume of injection exceeds 10ml as per body weight then it should be divided into two doses in each buttock nd oral allopurinol was given 15mg/kg in the form of tablets
Intervention group B: Patients were given drug via Intramuscular route meglumine antimoniate 15mg/kg if the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock or thigh.
Main outcome variables
Clinical/treatment response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N6
Registration date:2024-05-23, 1403/03/03
Registration timing:registered_while_recruiting
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-10, 1403/02/21
Expected recruitment end date
2024-06-06, 1403/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of intramuscular meglumine antimoniate plus oral allopurinol with intramuscular meglumine antimoniate alone in treatment of cutaneous leishmaniasis
Public title
Comparison of efficacy of intramuscular meglumine antimoniate plus oral allopurinol with intramuscular meglumine antimoniate alone in treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with biopsy proven leishmaniasis or has lesion(s) located in sites not compatible with local treatment for example lesions on or around eyes
Disfiguring lesion on face that lead to scarring
Lesions difficult to heal like on lower limbs
Lesion more than 4cm in size with sporotichoid spread
Multiple lesions
Exclusion criteria:
patients allergic to antimonials
Pregnant and breast feeding patients
Patients having mucosal, mucocutaneous or visceral leishmaniasis
Patients with comorbids (diabetes, hypertension, chronic liver disease, chronic kidney disease)
Immunosuppression patients
Baseline ECG abnormalities/heart disease
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation done by lottery method in which chits were kept in a jar and patient will be asked to pick one deciding their treatment regimen as per interventional group 1 and 2
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and data analyser are blinded by lottery method only researcher knows about blinding method participant/patient picks up a chit from the jar and decides the treatment method as per interventional group 1 and 2
before intervention and 2, 4 , 6 and 8 weeks after intervention until complete healing occurs then patient called for followup after 4 weeks
Method of measurement
Clinical response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Patients were given drug via Intramuscular route injection meglumine antimoniate 15mg/kg if dose exceeds 10ml then it should be divided into two doses given on each buttock plus oral allopurinol 15mg/kg in the form of of tablets.
Category
Treatment - Drugs
2
Description
Intervention group B: Patients were given drug via Intramuscular route injection meglumine antimoniate 15mg/kg. If the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Quetta
Full name of responsible person
Dr Zainab Kazam
Street address
Combined military hospital Quetta
City
Quetta
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Zainab Kazam
Street address
Combined military hospital Quetta
City
Quetta
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Grant name
Combined military hospital Quetta
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Quetta
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Zainab Kazam
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
CMH Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Zainab Kazam
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
CMH Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Zainab Kazam
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Combined military hospital Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcome
When the data will become available and for how long
One month after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
zainokazam@gmail.com
What processes are involved for a request to access data/document