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

ISRCTN	ISRCTN32701387
DOI	https://doi.org/10.1186/ISRCTN32701387
Protocol serial number	N/A
Sponsor	Skin Diseases and Leishmaniasis Research Center (SDLRC) (Iran)
Funder	Skin Diseases and Leishmaniasis Research Centre (SDLRC) at the University of Iran (Iran)

Submission date: 05/03/2006
Registration date: 15/06/2006
Last edited: 25/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mohammad Ali Nilfroushzadeh
Scientific

Khoram Street
Skin Diseases and Leishmaniasis Research Center
Isfahan
81876-98191
Iran

Phone	+98 (0)31 13373736
Email	nilfroushzadeh@mui.ac.ir

Study information

Primary study design	Interventional
Study design	Double-blind randomised study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Omeprazole, meglumine antimoniate (glucantime)
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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.
Completion date	28/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key 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.
Key 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.
Date of first enrolment	28/06/2004
Date of final enrolment	28/06/2005

Locations

Countries of recruitment

Iran

Study participating centre

Khoram Street

Isfahan
81876-98191
Iran

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008		Yes	No