This study will be a randomized double blind clinical trial on 90 patients of cutaneous leishmaniasis which refer to Gonbad Kavoos Cutaneous Leishmaniasis Treatment Center in 1394. patients randomly will be divided in two groups: cases and controls. All patients will be underwent standard treatment for cutaneous leishmaniasis (based on national guideline). Cases will give Aloe Vera gel 2 % and controls will give placebo. medication will be continue until the full lesion epithelialization or 4 weeks after last intervention. patient demographic information and morphological information of lesion (including the number of lesions, location, shape, and duration of lesions), the lesions healing and treatment result and clinical data will be recorded at the begining of the treatment, at the end of the first week, second, third, fourth (and if not cure happened at the end of forth week after the last intervention) wound healing and clinical information (including the size of the lesion, the size of the induration and the epithelialization) will be measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101224490N1
Registration date:2016-05-03, 1395/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Omid Mozafari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3322 5124
Email address
dr.mozafari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of Aloe vera 2% gel in treatment of Cutaneous Leishmaniasis (CL) on the base of Traditional Persian Medicine (TPM)
Public title
Assessing the effectiveness of Aloe vera 2% gel in treatment of Cutaneous Leishmaniasis (CL) on the base of Traditional Persian Medicine (TPM)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with lesions which lasts more than 14 days and definitely diagnosed cutaneous leishmaniasis by parasites seen in smears taken from skin lesions, and treating by the national standard treatment guidelines, after complete description of the study, in the case of consent to participate in the study are؛ Exclusion criteria: pregnant women, patients with allergy to antimuan, patients taking more than three months have passed since the first appearance of skin lesions, patients in recent months any way be used to treat leishmaniasis, patients which their wound on the eyelids, ear, nose or are less than one centimeter is near the end of the lips and eyes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed by using the random number tables
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Imam square, Joybar threeway, start of Valiye Asr highway, Sari
City
Sari
Postal code
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
1751- IR.MAZUMS.REC.94
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
longest diameter of ulceration area
Timepoint
0,7,14,21,28 day& if not cured 4 week after last intervention
Method of measurement
ruler
2
Description
longest diameter of Induration area
Timepoint
0,7,14,21,28 day& if not cured 4 week after last intervention
Method of measurement
ruler
3
Description
Healing rate
Timepoint
0,7,14,21,28 day& if not cured 4 week after last intervention
Method of measurement
observation & calculation
4
Description
treatment resualt
Timepoint
at the end of treatmen, and if lesion not full epithelialized 4 weeks after last intervention
Method of measurement
observation & determination
Secondary outcomes
1
Description
side effect
Timepoint
during treatment
Method of measurement
observation & interview
Intervention groups
1
Description
Intervention group: Aloe vera 2% Gel
two times a day
a layer
until the full lesion epithelialization or up to 4 weeks after last intervention
Category
Treatment - Drugs
2
Description
Control group: Placebo Gel
two times a day
a layer
until the full lesion epithelialization or up to 4 weeks after last intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonbad kavoos Health Center, Cutaneous Leishmaniasis Treatment Center
Full name of responsible person
Omid Mozafari
Street address
Gonbad Kavoos Health Center
City
Gonbad Kavoos
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Imam square, Joybar threeway, start of Valiye Asr highway, Sari
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Mozafari
Position
PhD student in Traditional Persian Medicine
Other areas of specialty/work
Street address
Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences
City
Sari
Postal code
497164885
Phone
+98 11 3324 4893
Fax
Email
dr.mozafari@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Syde Sedighe Yosefi
Position
assistant professor
Other areas of specialty/work
Street address
Imam square, Joybar threeway, start of Valiye Asr highway, Sari
City
Sari
Postal code
Phone
+98 11 3324 4893
Fax
+98 11 3324 4893
Email
dr_ssyosefi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Mozafari
Position
PhD student in Traditional Persian Medicine
Other areas of specialty/work
Street address
Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences
City
Sari
Postal code
4971684771
Phone
+98 17 3322 5124
Fax
+98 17 3329 4534
Email
dr.mozafari@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)