Effect of topical honey application along with intralesional injection of glucantime in the treatment of the cutaneous leishmaniasis

ISRCTN	ISRCTN12004149
DOI	https://doi.org/10.1186/ISRCTN12004149
Protocol serial number	84210
Sponsor	Skin Disease and Leishmaniasis Research Center (Iran)
Funder	Isfahan University of Medical Sciences, Skin Diseases and Leishmaiasis Research Center (Iran)

Submission date: 10/09/2006
Registration date: 13/11/2006
Last edited: 23/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mohhamad Ali Nilfroushzadeh
Scientific

Skin Disease and Leishmaniasis Research Center (SDLRC)
Sedighe Tahereh Research & Theraputic Center
Isfahan University of Medical Sciences
Isfahan
81876-98191
Iran

Email	sdlrc@mui.ac.ir

Study information

Primary study design	Interventional
Study design	This study was a controlled randomised clinical trial study
Secondary study design	Randomised controlled trial
Scientific title	Effect of topical honey application along with intralesional injection of glucantime in the treatment of the cutaneous leishmaniasis
Study objectives	Topical honey along with intralesional glucantime is more effective in the treatment of the cutaneous leishmaniasis than intralesional glucantime alone.
Ethics approval(s)	The study was approved by the ethics committee of the Skin Disease and Leishmaniasis Research Center (reference number: SEC. 84210).
Health condition(s) or problem(s) studied	Cutaneous leishmaniasis
Intervention	Topical honey along with intralesional glucantime versus intralesional glucantime alone.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Topical honey and intralesional glucantime
Primary outcome measure(s)	Curing of the leishmaiasis
Key secondary outcome measure(s)	Diameter of the lesion and size of the erythema, induration and ulcer
Completion date	22/10/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key 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
Key exclusion criteria	N/A
Date of first enrolment	21/12/2004
Date of final enrolment	22/10/2005

Locations

Countries of recruitment

Iran

Study participating centre

Skin Disease and Leishmaniasis Research Center (SDLRC)

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:	27/04/2007		Yes	No

Editorial Notes

23/01/2020: Internal review.