Condition category
Infections and Infestations
Date applied
10/09/2006
Date assigned
13/11/2006
Last edited
03/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17466071

Publication citations

  1. 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.

Additional files

Editorial Notes