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IRCT20210823052264N6 IRCT 2024-05-23 CMH Quetta 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 2024-05-10 anticipated 150 Complete https://irct.ir/trial/76713 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Cutaneous leishmaniasis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Primary outcome When: One month after publication To whom: People working in academic institutions Conditions: Many Where to obtain: zainokazam@gmail.com How to obtain: Request Comments: NA
public Dr Zainab Kazam
CMH Quetta
Quetta Pakistan 08762 +92 336 5534909 zainokazam@gmail.com CMH Quetta scientific Dr Zainab Kazam
CMH Quetta
Quetta Pakistan 08762 +92 336 5534909 zainokazam@gmail.com CMH Quetta Pakistan 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 18 years 55 years Both 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 B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs 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. 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 Healing of lesion in response to treatment. Timepoint: 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. CMH Quetta Approved 2024-04-19 Institutional Ethical Review Board Certificate-CMH Quetta Combined military hospital Quetta Quetta Balochistan Pakistan