]>
IRCT20210823052264N4 IRCT 2024-04-03 CMH Quetta Comparison of Efficacy of Intravenous Versus Intramuscular Injection Meglumine Antimoniate in patients of Cutaneous Leishmaniasis Comparison of Efficacy of Intravenous Versus Intramuscular Injection Meglumine Antimoniate in patients of Cutaneous Leishmaniasis 2024-04-01 anticipated 90 Complete https://irct.ir/trial/76096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen, Blinding description: participants and data analyzer were blinded. 3 cutaneous leishmaniaisis. Intervention 1: Intervention group A: Patients were given drug via Intravenous route. The drug should be given diluted in 50–200 ml of 5% glucose solution over 30–60 minutes in ICU/HDU with cardiac monitoring. Intervention 2: Intervention group B: Patients were given drug via Intramuscular route. If the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock or thigh. 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: shafiashaikh994@gmail.com How to obtain: Request Comments: NA
public Dr. Shafia Shaikh
ofh2
quetta Pakistan 08734 +92 324 4153402 shafiashaikh994@gmail.com CMH Quetta scientific Dr. Shafia Shaikh
ofh2
quetta Pakistan 08734 +92 324 4153402 shafiashaikh994@gmail.com CMH Quetta Pakistan All patients with biopsy proven leishmaniasis plus any of the following: has lesion(s) located in sites not compatible with local treatment for example eyelids lesions in which scaring would be disabling or severely disfiguring like on face lesions that will have difficulting in healing like on lower limb or over a joint lesions involving mucosa or cartilage lesion ≥4 cm lesion with sporotrichoid spread multiple lesions 15 years 80 years Both patients allergic to antimonials the lesion is already self-curing pregnant and breast feeding women those who refused to accept the diagnostic procedures 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/Heart disease B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group A: Patients were given drug via Intravenous route. The drug should be given diluted in 50–200 ml of 5% glucose solution over 30–60 minutes in ICU/HDU with cardiac monitoring Intervention group B: Patients were given drug via Intramuscular route. If the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock or thigh. Healing of lesion in response to treatment. Timepoint: before intervention and 2, 4 , 6 and 8 weeks after intervention until complete healing occur than patient called for followup after 4 weeks. Method of measurement: Clinical Response Evaluation. CMH Quetta Approved 2024-03-29 Institutional Ethical Review Board Certificate-CMH QUETTA Ofh2 cmh quetta Quetta Balochistan Pakistan