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
Secondary identifying numbers 84210
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

Study designThis study was a controlled randomised clinical trial study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of topical honey application along with intralesional injection of glucantime in the treatment of the cutaneous leishmaniasis
Study objectivesTopical 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) studiedCutaneous leishmaniasis
InterventionTopical honey along with intralesional glucantime versus intralesional glucantime alone.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Topical honey and intralesional glucantime
Primary outcome measureCuring of the leishmaiasis
Secondary outcome measuresDiameter of the lesion and size of the erythema, induration and ulcer
Overall study start date21/12/2004
Completion date22/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteria1. 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 criteriaN/A
Date of first enrolment21/12/2004
Date of final enrolment22/10/2005

Locations

Countries of recruitment

  • Iran

Study participating centre

Skin Disease and Leishmaniasis Research Center (SDLRC)
Isfahan
81876-98191
Iran

Sponsor information

Skin Disease and Leishmaniasis Research Center (Iran)
Research organisation

Sedighe Tahereh Research & Theraputic Center
Khoram Street
Jomhory Square
Isfahan
81876-98191
Iran

Email sdlrc@mui.ac.ir
ROR logo "ROR" https://ror.org/04waqzz56

Funders

Funder type

University/education

Isfahan University of Medical Sciences, Skin Diseases and Leishmaiasis Research Center (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.