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A comparative study of the efficacy of combination therapy with oral omeprazole and low dose of systemic meglumine antimoniate versus the standard dose of systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32701387
Enrollment
150
Registered
2006-06-15
Start date
2004-06-28
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous leishmaniasis Skin and Connective Tissue Diseases Cutaneous leishmaniasis

Interventions

Group 1 was treated with intramuscular 60 mg/kg/day glucantime (MA) and placebo for three weeks. Group 2 was treated with intramuscular 30 mg/kg/day glucantime and 40 mg of the oral omeprazole for thr

Sponsors

Skin Diseases and Leishmaniasis Research Center (SDLRC) (Iran)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the patients had positive smear for leishman body and have not received any topical or systemic therapy for leishmaniasis. The age of patients was between 7-70 years old.

Exclusion criteria

Exclusion criteria: Patients who were pregnant or lactating and patients with history of cardiac, renal, hepatic diseases or patients with any contraindication for treatment were excluded.

Design outcomes

Primary

MeasureTime frame
Healing rate during the course of treatment was more in the groups treated with standard dose glucantime and placebo and low dose glucantime and omeprazole than the group treated with low dose glucantime and placebo (P <0.05).

Secondary

MeasureTime frame
Combination therapy with oral omeprazole and low dose of glucantime can be used as alternative treatment for leishmaniasis especially in patients with history of cardiac, renal, and hepatic disease. Patients with cardiac diseases were excluded because of some cardiac effects of the glucantime. However, glucantime is not absolutely contraindicated in patients with cardiac diseases and it can be prescribed with ECG monitoring. The study showed that the use of omeprazole as adjuvant therapy will decrease the dose of glucantime for the treatment of cutaneous leishmaniasis and therefore possibly decrease the risk of cardiac events attributed to the use of full dose of glucantime.

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026