The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
The effect of topical cream containing Chelidonium majus and and Hyoscyamus niger with propolis on healing cutaneous Leishmaniasis
Design
The clinical trial is designed as an intervention with a control group, double-blind, randomized, in phase 3 on 88 patients.
Settings and conduct
A double-blind study is performed on 88 patients with diabetic ulcers in Shahid Beheshti of Kashan and Al Zahra of Isfahan hospitals. The doctor and the patient do not know the type of treatment. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The duration of each cream will be 7days and the treatment will be done once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Entry requirements include men and women at least 12 years of age Positive leishmania smear
Exclusion criteria: Pregnancy, breast feeding,
Number of lesion over ten
Intervention groups
Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Control group: Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Main outcome variables
Measuring the size of lesion induration diameter with caliper
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N5
Registration date:2022-04-12, 1401/01/23
Registration timing:prospective
Last update:2022-04-12, 1401/01/23
Update count:3
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
Public title
The effect of Chelidonium majus and hyoscyamus niger with propolis on cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Entry requirements include men and women at least 12 years of age
Positive leishmania smear
Exclusion criteria:
Pregnancy, breast feeding,
Number of lesion over ten
Age
From 12 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on cream and only the epidemiologist informs as a plan executor.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and placebo cream is completely identical in terms of the shape and size of the container, and the cream themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or controlled drug . Clinicians and patients will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.199
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
Complete healing
Timepoint
At the beginning of the study, 2 and 4 days after treatment and 7 days after treatment, 14 days after treatment, 21 days after treatment
Method of measurement
measuring the size of lesion induration diameter with caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Morteza kosari
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital of Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
10
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
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimortza12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan
City
Isfehan
Province
Isfehan
Postal code
8715988141
Phone
+98 87 1598 8141
Email
kosarimorteza12@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
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
Title and more details about the data/document
Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported.
When the data will become available and for how long
The start of the access period will be 6 months after patent presentation or 12 months after article publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutes.