Comparing the effectiveness of Sambucus Ebulus leaf extract ointment and placebo, in treatment results of Cutaneous Leishmaniasis; A double blind clinical trial
Determination of the effect of of Sambucus Ebulus leaf extract ointment in treatment of cutaneous leishmaniasis.
Determination of the effect of of Sambucus Ebulus leaf extract ointment in reducing of the diameter of cutaneous leishmaniasis ulcer.
Determination of the effect of of Sambucus Ebulus leaf extract ointment in reducing of the diameter of cutaneous leishmaniasis induration.
Determination of the effect of of Sambucus Ebulus leaf extract ointment in healing rate of cutaneous leishmaniasis.
Determination of the effect of of Sambucus Ebulus leaf extract ointment in treatment results of cutaneous leishmaniasis.
Design
This study will be a randomized double-blind clinical trial on 110 patients of cutaneous leishmaniasis. Patients will be divided into intervention and Control groups based on Simple Random Allocation (random numbers table). Each patient will give a unique code.
Settings and conduct
Patients who are refered to "Cutaneous Leishmaniasis treatment Center" placed in Gonbad kavoos Health Center in 1396 will be studied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with confirmed cutaneous leishmaniasis diagnosis.
Exclusion criteria: pregnant women; patients with allergy to antimuan; patients with lesions lasting more than 3 month; patients whose wound is on the eyelids, ear, nose or are less than one centimeter from the end of the lips and eyes.
Intervention groups
All patients will get treatment based on National guideline. In addition, patients in intervention group will get Sambucus Ebulus leaf extract ointment and controls will get placebo. Medication will be continued until the full lesion epithelialization occurrance or up to 4 weeks.
Main outcome variables
longest diameter of ulceration area; longest diameter of Induration area; Healing rate; treatment result
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151012024490N2
Registration date:2018-01-01, 1396/10/11
Registration timing:registered_while_recruiting
Last update:2018-01-01, 1396/10/11
Update count:0
Registration date
2018-01-01, 1396/10/11
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
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Sambucus Ebulus leaf extract ointment and placebo, in treatment results of Cutaneous Leishmaniasis; A double blind clinical trial
Public title
Effectiveness of Sambucus Ebulus leaf extract ointment in treatment results of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with confirmed cutaneous leishmaniasis diagnosis
Exclusion criteria:
pregnant women
patients with allergy to antimuan
passing more than three months from the first existence of skin lesions
getting any treatment for leishmaniasis in recent month
patients whose wounds are on the eyelids, ear, nose or near the end of the lips and eyes (less than one centimeter)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups; cases and controls based on Simple Random Allocation (random numbers table).
Blinding (investigator's opinion)
Double blinded
Blinding description
All cases and controls will get an ointment which looked like in shape, color and smell. And each patient will get an unique code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Phalsaphy complex, Shast kola Road
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2017-11-28, 1396/09/07
Ethics committee reference number
IR.Goums.REC.13960220
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
At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks.
Method of measurement
ruler
2
Description
longest diameter of Induration area
Timepoint
At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks.
Method of measurement
ruler
3
Description
Healing rate
Timepoint
At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks.
Method of measurement
observation & calculation
4
Description
treatment result
Timepoint
During treatment or during 4 weeks after treatment
Method of measurement
observation & calculation
5
Description
healing rate
Timepoint
During treatment or during 4 weeks after treatment
Method of measurement
observation & calculation
Secondary outcomes
empty
Intervention groups
1
Description
Sambucus Ebulus leaf extract ointment. In order to prepare the ointment, a 5% extract of the plant leaves in vaseline (and liquid paraffin) will be used. This drug will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time.
Category
Treatment - Drugs
2
Description
Placebo ointment contains the base compound (Vaseline and liquid paraffin) that will be similar to the drug in shape and smell and only the active ingredient will be absent. This placebo will be made at Mazandaran University of Medical Sciences. The ointment will be used twice a day. First the lesion should be washed with water. After drying, a thin layer of ointment should be used and the area should be kept dry for about two hours. It is forbidden to use other medications at the treatment time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonbad Kavoos Health Center- Cutaneous Leishmaniasis Treatment Center
Full name of responsible person
Safoora Saberi
Street address
Health Center, Sarabi street.
City
Gonbad Kavoos
Province
Golestan
Postal code
4971684471
Phone
+98 17 3328 8512
Fax
+98 17 3328 8512
Email
dr.mozafari@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=48
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohamadreza Honarvar
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 1289
Fax
+98 17 3242 1660
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Safoora Saberi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Health Center, Sarabi street
City
Gonbad kavoos
Province
Golestan
Postal code
6721611784771
Phone
+98 17 3328 6852
Fax
+98 17 3328 6852
Email
dr.mozafari@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=48
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Omid Mozafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of medicine, Golestan University of Medical Sciences, Shast kola, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3322 5124
Fax
+98 17 3322 5124
Email
dr.mozafari@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Omid Mozafari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of medicine, Golestan University of Medical Sciences, Shast kola, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3322 5124
Fax
+98 17 3322 5124
Email
dr.mozafari@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available