Evaluating the effectiveness of topical Myrrh (Commiphora myrrha) product on skin lesion healing in patients infected with Leishmania major - A pilot study
Determining the effect of topical product of Myrrh in the healing of the lesion caused by Leishmania major
Design
This study conducted as a pilot study with before - after intervention and will run in the leishmaniasis treatment center. 10 patients within the accepted patients who complete informed consent form will be included in the study
Settings and conduct
Study will be run in the leishmaniasis treatment Center in Orzoiyeh city and selected patients will use topical cream of 5% Myrrh on the lesions twice a day for 4 weeks. Patients will be visited weekly by an expert and the lesions will be measured
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Cutaneous leishmaniasis, age 8 to 60 years, Number of lesions less than 5, Ulcer size less than 5 cm, Duration of lesion less than 3 months, Receiving no anti-leishmania treatment remedies during the past 3 months, Completing the informed consent form;
Exclusion criteria: Pregnancy and lactating, Patients with underlying diseases and allergy, Lesions on joint, face and sensitive organs, Regional adenopathy.
Intervention groups
Patients will use the topical product containing 5% Myrrh gum in the standard base cream prepared in the comprehensive pharmaceutical laboratory twice a day on the skin lesions in an amount that completely covers the lesion for a period of 4 weeks.
Main outcome variables
Size of wound; Induration of wound; healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059337N1
Registration date:2023-10-07, 1402/07/15
Registration timing:prospective
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Mehdi Shafiei_bafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3131 5724
Email address
kmushafiei51@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of topical Myrrh (Commiphora myrrha) product on skin lesion healing in patients infected with Leishmania major - A pilot study
Public title
Effect of Myrrh in treatment of leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cutaneous leishmaniasis by leishmania major
Number of skin lesions less than 5
Ulcer size less than 5 cm
Duration of lesions no more than 3 months
Receiving no anti-leishmania treatment remedies during the past 3 months
Completing the informed consent form
Exclusion criteria:
Pregnancy and lactation
Underlying diseases and allergy
Lesions on joints, face and sensitive organs
Regional adenopathy
Age
From 8 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.KMU.REC.1402.141
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 Leishmania lesion
Timepoint
in 0,1,2,3,4,6,8 weeks of treatment
Method of measurement
WoundDesk app
2
Description
Induration of lesion
Timepoint
in 0,1,2,3,4,6,8 weeks of treatment
Method of measurement
Digital Caliper
3
Description
Wound healing time
Timepoint
in 0,1,2,3,4,6,8 weeks of treatment
Method of measurement
Counting of weeks
Secondary outcomes
empty
Intervention groups
1
Description
Patients will use the topical product containing 5% Myrrh gum in the standard base cream prepared in the comprehensive pharmaceutical laboratory twice a day on the skin lesions in an amount that completely covers the lesion for a period of 4 weeks. This patients will be visited by an expert at the start of treatment and in weeks 1, 2, 3, 4, 6, 8 and induration of lesions and size of wounds will be measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Leishmania Treatment Center
Full name of responsible person
Mehdi Shafiei_bafti
Street address
Health Center Office, Khalij-e-fars Blvd
City
Orzoeyeh
Province
Kerman
Postal code
7859113958
Phone
+98 34 4248 0126
Fax
+98 34 4248 0126
Email
kmushafiei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpoor
Street address
Deputy for Research and Technology Building, Ebn-e-Sina St., Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Shafiei_bafti
Position
Head of CDC
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Deputy for Health office, Jomhori Blvd
City
Kerman
Province
Kerman
Postal code
7618874765
Phone
+98 34 3131 5724
Fax
Email
kmushafiei51@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Shafiei_bafti
Position
Head of CDC
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Deputy for Health office, Jomhori Blvd
City
Kerman
Province
Kerman
Postal code
7618874765
Phone
+98 34 3131 5724
Fax
Email
kmushafiei51@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Shafiei_bafti
Position
Head of CDC
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Deputy for Health Office, Jomhori Blvd
City
Kerman
Province
Kerman
Postal code
7618874765
Phone
+98 34 3131 5724
Fax
Email
kmushafiei51@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Research data can be shared as an Excel file without personal information
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Academic researchers with an official request from the academic center
Under which criteria data/document could be used
For use in statistical analysis by declaring the source of data
From where data/document is obtainable
Leishmaniasis Research Center, Kerman University of Medical Sciences
Email: leishmaniasis@kmu.ac.ir
What processes are involved for a request to access data/document
Sending an official request to the announced email, that will be answered within a month after receiving