Effect of topical honey application along with intralesional injection of glucantime in the treatment of the cutaneous leishmaniasis
ISRCTN | ISRCTN12004149 |
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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
Scientific
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 |
Study information
Study design | This study was a controlled randomised clinical trial study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 21/12/2004 |
Completion date | 22/10/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
81876-98191
Iran
Sponsor information
Skin Disease and Leishmaniasis Research Center (Iran)
Research organisation
Research organisation
Sedighe Tahereh Research & Theraputic Center
Khoram Street
Jomhory Square
Isfahan
81876-98191
Iran
sdlrc@mui.ac.ir | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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.