Objectives: Comparison of Electrotherapy and intralesional injection of Glucantime in the treatment of Coetaneous Leishmaniasis Design: Not blinded randomized clinical trial Setting and conduct: 60 patients with Cutaneous Leishmaniasis were randomly divided into two groups. In intervention group(n=30) Electrotherapy was performed and control group(n=30) were treated with intralesional injection of Glucantime Major Inclusion and Exclusion criteria: Inclusion criteria: the lack of local or systemic treatment for Cutaneous Leishmaniasis; the appearance of skin lesions is less than 12 weeks ego. Exclusion criteria: age less than 2 years, previous history of cutaneous leishmaniasis; pregnant or lactating women; malnutrition and underlying severe disease; contraindications for drug administration. Intervention: Electrotherapy was performed once a week in the intervention group and the control group were treated with intralesional injection of Glucantime twice a week. Main outcome measures(variables): Lesion size, secretion, inflammation and blister.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016011822583N3
Registration date:2016-02-28, 1394/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Mohsen Shoja
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 85 3722 2469
Email address
mohsenshoja61@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of North Khorasan University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of Electrotherapy and intralesional injection of Glucantime in the treatment duration of Coetaneous Leishmaniasis
Public title
Comparison of Electrotherapy and intralesional injection of Glucantime in the treatment of Coetaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the lack of local or systemic treatment for Cutaneous Leishmaniasis; the appearance of skin lesions is less than 12 weeks ego.
Exclusion criteria: age less than 2 years; previous history of Cutaneous Leishmaniasis; pregnant or lactating women; malnutrition and underlying severe disease; contraindications for drug administration.
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
North Khorasan University of Medical Sciences, Shahriar Street, Bojnurd, North Khorasan
City
Bojnurd
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
673/پ/ 92
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Size of lesion
Timepoint
Once a week
Method of measurement
Ruler
2
Description
Recovery time
Timepoint
Once a week
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Inflammation
Timepoint
Once a week
Method of measurement
Clinical observation
2
Description
Blisters around the lesion
Timepoint
Once a week
Method of measurement
Clinical observation
3
Description
Secretion of the lesion
Timepoint
Once a week
Method of measurement
Clinical observation
Intervention groups
1
Description
The Electrotherapy was performed in the intervention group once per week.The lesion was received an electric current with 40 volts and 5-15 ampere for 10 minutes.
Category
Treatment - Other
2
Description
In the control group, Glucantime ampoule(5ml) were injected intralesional, twice a week and was continued until around the lesion was white.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfarayen health center
Full name of responsible person
Alireza Akrami
Street address
Esfarayen health center, Taleghani Street, Esfarayen, North Khorasan
City
Esfarayen
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of North Khorasan University of Medical Sciences
Full name of responsible person
Mahdi Bakhsh Abadi
Street address
North Khorasan University of Medical Sciences, Shahriar Street, Bojnurd, North Khorasan
City
Bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of North Khorasan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Esfarayen faculty of Medical Sciences
Full name of responsible person
Mohsen Shoja
Position
MSc of Epidemiology
Other areas of specialty/work
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North khorasan
City
Esfarayen
Postal code
9661856188
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences, Bojnurd
Full name of responsible person
Esmaeil Shoja
Position
Post Graduate
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences, Shahriar Street, Bojnurd, North Khorasan
City
Bojnurd
Postal code
Phone
00
Fax
Email
shoja.esmaeil@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen Faculty of Medical Sciences
Full name of responsible person
Mohsen Shoja
Position
Msc of Epidemiology
Other areas of specialty/work
Street address
Esfarayen Faculty of Medical Sciences, Emam Reza Street, Esfarayen, North khorasan
City
Esfarayen
Postal code
9661856188
Phone
+98 58 3724 1601
Fax
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)