Contact information
Type
Scientific
Primary contact
Dr Mohammad Ali Nilfroushzadeh
ORCID ID
Contact details
Khoram Street
Skin Diseases and Leishmaniasis Research Center
Isfahan
81876-98191
Iran
+98 (0)31 13373736
nilfroushzadeh@mui.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The effect of oral omeprazole and low dose systemic meglumine antimoniate (MA) is more than the standard dose of systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis.
Ethics approval
The research has been ethically approved by the Ethical committee of the Skin Diseases and Leishmaniasis Research Center (SDLRC) on 11/02/2003, reference number: 85318
Study design
Double-blind randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cutaneous leishmaniasis
Intervention
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 three weeks.
Group 3 was treated with intramuscular 30 mg/kg/day glucantime and oral placebo for three weeks
Intervention type
Drug
Phase
Not Specified
Drug names
Omeprazole, meglumine antimoniate (glucantime)
Primary outcome measure
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 outcome measures
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.
Overall trial start date
28/06/2004
Overall trial end date
28/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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.
Recruitment start date
28/06/2004
Recruitment end date
28/06/2005
Locations
Countries of recruitment
Iran
Trial participating centre
Khoram Street
Isfahan
81876-98191
Iran
Sponsor information
Organisation
Skin Diseases and Leishmaniasis Research Center (SDLRC) (Iran)
Sponsor details
Khoram Street
Isfahan
81876-98191
Iran
+98 (0)31 13373736
sdlrc@mui.ac.ir
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Skin Diseases and Leishmaniasis Research Centre (SDLRC) at the University of Iran (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19248655
Publication citations
-
Results
Nilforoushzadeh MA, Jaffary F, Ansari N, Siadat AH, Nilforoushan Z, Firouz A, A comparative study between the efficacy of systemic meglumine antimoniate therapy with standard or low dose plus oral omeprazole in the treatment of cutaneous leishmaniasis., J Vector Borne Dis, 2008, 45, 4, 287-291.