Contact information
Type
Scientific
Primary contact
Dr Mohhamad Ali Nilfroushzadeh
ORCID ID
Contact details
Skin Disease and Leishmaniasis Research Center (SDLRC)
Sedighe Tahereh Research & Theraputic Center
Isfahan University of Medical Sciences
Isfahan
81876-98191
Iran
sdlrc@mui.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
84210
Study information
Scientific title
Acronym
Study hypothesis
Topical honey along with intralesional glucantime is more effective in the treatment of the cutaneous leishmaniasis than intralesional glucantime alone.
Ethics approval
The study was approved by the ethics committee of the Skin Disease and Leishmaniasis Research Center (reference number: SEC. 84210).
Study design
This study was a controlled randomised clinical trial study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cutaneous Leishmaniasis
Intervention
Topical honey along with intralesional glucantime versus intralesional glucantime alone.
Intervention type
Drug
Phase
Not Specified
Drug names
Topical honey and intralesional glucantime
Primary outcome measure
Curing of the leishmaiasis
Secondary outcome measures
Diameter of the lesion and size of the erythema, induration and ulcer
Overall trial start date
21/12/2004
Overall trial end date
22/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Confirmed cutaneous leishmaniasis with direct smear
2. No history of systemic or topical therapy for cutaneous leishmaniasis
3. Absence of the malnutrition or severe predisposing disease such as cardiac, renal or hepatic disease and other contraindication for glucantime
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
N/A
Recruitment start date
21/12/2004
Recruitment end date
22/10/2005
Locations
Countries of recruitment
Iran
Trial participating centre
Skin Disease and Leishmaniasis Research Center (SDLRC)
Isfahan
81876-98191
Iran
Sponsor information
Organisation
Skin Disease and Leishmaniasis Research Center (Iran)
Sponsor details
Sedighe Tahereh Research & Theraputic Center
Khoram Street
Jomhory Square
Isfahan
81876-98191
Iraq
sdlrc@mui.ac.ir
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
Isfahan University of Medical Sciences, Skin Diseases and Leishmaiasis Research Center (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
Publication citations
-
Results
Nilforoushzadeh MA, Jaffary F, Moradi S, Derakhshan R, Haftbaradaran E, Effect of topical honey application along with intralesional injection of glucantime in the treatment of cutaneous leishmaniasis., BMC Complement Altern Med, 2007, 7, 13, doi: 10.1186/1472-6882-7-13.