Utilization of an effective and low-risk herbal ointment for cutaneous leishmaniasis treatment.
Design
Sampling method: simple and accessible
Sample size: 60 patients
In data analysis, first, the normality of the data was examined using a one-sample Klomogorov-Smirnov test with Lily-Fars modification. By confirming the normality, appropriate parametric methods such as the student test were used, and if not normal. Mann-Whitney and Wilcoxon tests are used. In analyzing data with nominal scale, Chi-square test is used and in cases where more than 20% of the expected frequencies of tables are less than 5 (Cochran), Fisher's exact test is used. Analysis of covariance will be used to evaluate the results. The software used in this study is IBM-SPSS v.25 and the significance level of the tests is less than 5%.
Settings and conduct
Study type: Clinical trial
Location: Sima Teb Clinic and Innovation Research Center of Shahinfar Medical School - Islamic Azad University of Mashhad.
Participants/Inclusion and exclusion criteria
Admission: Patients with active leishmaniasis ulcers on their skin for less than 4 months.
No entry: People with inactive leishmaniasis ulcers on their skin.
Intervention groups
30 patients who diagnosed with leishmaniasis and took sampling for the spread of suspicious skin lesions before and after treatments with pathologist approval. This group receives selective treatment for leishmaniasis (as confirmed by a dermatologist including paromomycin, fluconazole, or pentamidine) and the herbal medicine of Oak at the same time.
Nevertheless, The control group of other 30 patients with leishmaniasis ulcers, receives only selective treatment for leishmaniasis.
Evaluation of the effect of herbal medicine prepared from Oak in human phase in patients with cutaneous leishmaniasis.
Public title
Evaluation of the effect of Oak powder for the treatment of leishmaniasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with active leishmaniasis ulcers on a part of their body.
Patients with less than 4 months of leishmaniasis develops on their skin.
Exclusion criteria:
Patients with inactive leishmaniasis on their skin.
Any drug allergy recognition by medical practitioner.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
volunteer participants will only keep blind in this trial.
Placebo
Not used
Assignment
Other
Other design features
In the following research, 60 leishmaniasis positive cases are going to be examined by a dermatologist and in case of confirmation, they will be divided into 2 groups. First group including 30 patients prescribed with topical cream made of Oak extract in combination with Sina Emfolish topical ointment or at the discretion of the physician with additional glucantime. The second group receive common treatments for leishmaniasis as of topical ointment of Sina Emfolish, and at the discretion with additional glucantime. Procedure started by taking smear from wounded skin area for direct and molecular smear tests. Then treatments continue with twice daily usage of topical ointment. After two months, once again smear will be taken from wounded area. Meanwhile dermatologist survey clinical status of the wound and report every case condition. Second group treatment duration is in accordance with remedy protocols and dermatologist discretion.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research - Islamic Azad University, Mashhad Branch
Street address
Faculty of Medicine, Azad University of Mashhad,14th Imam Khomeini St., 14th Imam Khomeini St., Imam Khomeini Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9133683633
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.IAU.MSHD.REC.1399.091
Health conditions studied
1
Description of health condition studied
Leishmaniasis
ICD-10 code
B55
ICD-10 code description
Leishmaniasis
Primary outcomes
1
Description
wounds larger than ≥ 3 cm
Timepoint
Before treatments begin and 8 weeks after it
Method of measurement
Direct blood smear and PCR test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: cases under treatment with Oak ointment. Ingredients: Oak ointment, Density of 8g in 100 dosage of use. Consumption: Once a day with refreshing bondage. Number of usage: 20 times. Period: 20 days. Method: Topical. Manufacturer: Zojaj Daru
Category
Treatment - Drugs
2
Description
Control group: group treated with common drug. Consumption: Glucantime ampoule or Sina ampoule ointment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sima Teb Clinic
Full name of responsible person
Vahid Sepehr
Street address
No. 96, Kolahdooz Boulevard 8th, Kolahdooz Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183837341
Phone
+98 51 3845 9666
Fax
+98 51 3846 2869
Email
info@simateb.com
Web page address
http://www.simateb.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Marham Sazan Moghan Daroo Company
Full name of responsible person
Majid Zowghi Kakhki
Street address
Unit 3, 20th floor, Alton Tower, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138833114
Phone
+98 51 3129 1704
Email
m.zowghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Marham Sazan Moghan Daroo Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Sima Teb Clinic
Full name of responsible person
Vahid Sepehr
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 96, Kolahdooz 8th, Kolahdooz Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183837341
Phone
+98 51 3845 9666
Fax
+98 51 3846 2869
Email
info@simateb.com
Web page address
http://www.simateb.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine, Islamic Azad University, Mashhad Branch
Full name of responsible person
Mohammad Reza Khakzad
Position
Director of Medical Innovation Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Shahin Far College, Imam Khomeini 14th, Imam Khomeini Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9133683666
Phone
+98 51 3225 6291
Fax
+98 51 3225 0048
Email
mr.khakzad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Islamic Azad University, Mashhad Branch
Full name of responsible person
Mohammad Reza Khakzad
Position
Director of Medical Innovation Center
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Shahin Far College, Imam Khomeini 14th, Imam Khomeini Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9133683633
Phone
+98 51 3225 6291
Fax
+98 51 3225 0048
Email
mr.khakzad@gmail.com
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
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
Consent form;
- This form is in accordance with the information related to the research and prepared in non-specialized and understandable literature for sixth grade graduates.
- Simple and fluent sentences are used to make forms comprehension easier.
- Each paragraph provided with more explanations in the form of comments for better adjustment and understanding.
- In case of underage participation, it has been stated that the participant is a child or a person who does not have the authority to decide, and the cases where the meaning of "I" was the participant has been changed to "child" or "the person under my care". Also in items where "I" refers to the person approval, it changed to "guardian" or "legal guardian".
When the data will become available and for how long
6 months
To whom data/document is available
Researchers
Under which criteria data/document could be used
Only wound macroscopic results
From where data/document is obtainable
Research Supervisor:
Dr. Mohammad Reza Khakzad - Faculty of Medicine, Azad University of Mashhad
What processes are involved for a request to access data/document
Contact via email with Dr. Mohammad Reza Khakzad at: mr.khakzad@gmail.com
Comments
According to the ethical documentation of the project, the information of this research will remain confidential with the treating physicians and will be sent only through the person in charge of the research to researchers who intend to improve the treatment of patients.