Preparation of topical nanoliposomal formulation of berberis vulgaris extract and its effect on cutaneous leishmaniasis
Design
According to the ethics committee's opinion, first, the evaluations will be done on 5 patients. After the approval by the Ethics Committee of the Mashhad University of Medical Sciences, other patients will be added up to 12 patients.
The study does not have randomization or blinding
Settings and conduct
The study is carried out among patients with positive smears who are referred to the skin clinic of Imam Reza Hospital in Mashhad. To avoid any unwanted side effects that affect people's beauty, patients without facial lesions are included in the study. Before starting the study, a consent letter is obtained from the patients and information about the project is given to them.
For 8 weeks, patients apply a 2 mm thick layer of nanoliposome cream containing barberis extract on the area twice a day and bandage it.
Participants/Inclusion and exclusion criteria
People aged 20 to 70 with leishmaniasis in the body (not face), that they are not suffering from another disease
Intervention groups
Patients who apply a 2 mm thick layer of nanoliposomal cream containing berberis vulgaris extract twice a day for 8 weeks and bandage it
Main outcome variables
Lesions size is checked and recorded every week and rated as follows:
Complete recovery: 100% healing of the wound and its secretions
Significant healing: healing between 76 and 99 percent
Partial healing: healing between 51 and 75 percent
Partial recovery: recovery between 26 and 50% compared to the initial wound
Non-healing: reducing the size of the wound to less than 26% of the initial wound
Treatment failure: no change in wound size or discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240510061730N1
Registration date:2024-06-07, 1403/03/18
Registration timing:prospective
Last update:2024-06-07, 1403/03/18
Update count:0
Registration date
2024-06-07, 1403/03/18
Registrant information
Name
Mohaddeseh Sadat Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 7674
Email address
alavimhd2@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the protective effects of berberis vulgaris roots nanoliposome against cutaneous leishmaniasis
Public title
Evaluation of the berberis vulgaris effects against leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive leishmaniosis disease (except face)
not pregnant
ages: 20-70 y
not other diseases
normal kidney and liver tests
Exclusion criteria:
Facial lesions
pregnancy and lactation
Immunosuppressive medications
Age
From 20 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
12
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 Mashhad University of Medical Sciences
Street address
Ferdowsi university, Medicine faculty of Mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9188759009
Approval date
2023-09-05, 1402/06/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.323
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
Lesion size
Timepoint
Measurement of lesion size before starting treatment, every week during treatment (0 to 8)
Method of measurement
Complete recovery: 100% healing of the wound and its secretions, Significant healing: healing between 76 and 99 percent, Partial healing: healing between 51 and 75%, Partial recovery: recovery between 26 and 50%, Non-healing: reducing the size of the wound to less than 26%, Treatment failure: no change in wound size or discharge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who apply a 2 mm thick layer of nanoliposomal cream containing berberis vulgaris extract twice a day for 8 weeks and bandage it
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hasan Rakhshandeh
Street address
Ferdowsi university, Medicine faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9188759009
Phone
+98 51 3800 2265
Email
Rakhshandehh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Rakhshandeh
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9188759009
Phone
+98 51 3800 2265
Email
rakhshandehh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Rakhshandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3800 2258
Email
rakhshandehh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Rakhshandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ferdowsi university
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3800 2258
Email
rakhshandehh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohaddeseh Sadat Alavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 210, Seyed Razi 45, Seyed Razi blvd, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188759009
Phone
+98 51 3601 7674
Email
alavimhd2@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Documentation related to the change in the size of lesions will be published after the end of the study
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers and scientists
Under which criteria data/document could be used
researchers in the field of dermatology, traditional medicine and medicinal plants
From where data/document is obtainable
Dr Hasan Rakhshandeh
09155036929
medicine faculty, mashhad university of medical sciences
rakhshandehh@mums.ac.ir
What processes are involved for a request to access data/document
data/document will be available upon request from Dr. Rakhshandeh