Protocol summary
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Study aim
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The effect of topical cream containing Chelidonium majus and Hyoscyamus niger with propolis on the improvement of Cutaneous leishmaniasis
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Design
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The randomized clinical trial that in the first phase, it will be interventional and have a control group, and it will be double-blind. In phase 2, blinding is not done and the drug is given to the patient as the main drug.
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Settings and conduct
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A double-blind study on 150 patients with cutaneous leishmaniasis is carried out in several centers under the 3rd group of Kashan University of Medical Sciences and Isfahan Medical Sciences and the Health Vice-Chancellor of Esfrain Medical School in North Khorasan.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Patients aged at least 12 years of both sexes
2- Positive leishmania smear
Exclusion criteria:
1- Pregnancy and breast feeding
2- Number of lesions over ten
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Intervention groups
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Intervention group:
The intervention group includes 150 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger along with 2 grams of propolis is used for three weeks. The duration of the use 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:
The control group includes 150 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use 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 and provided to the patients in the same tube as the intervention group.
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Main outcome variables
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Measuring the diameter of lesion induration using a caliper
General information
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Reason for update
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Completion of the first phase and the second phase of the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200516047462N5
Registration date:
2022-04-12, 1401/01/23
Registration timing:
prospective
Last update:
2023-09-17, 1402/06/26
Update count:
3
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Registration date
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2022-04-12, 1401/01/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-21, 1401/02/01
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Expected recruitment end date
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2023-01-21, 1401/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
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Public title
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The effect of Chelidonium majus and hyoscyamus niger with propolis on cutaneous Leishmaniasis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients aged at least 12 years of both sexes
Positive leishmania smear
Real time PCR
Exclusion criteria:
Pregnancy and breastfeeding
The number of lesions more than 10
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Age
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From 12 years old to 85 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sample is divided into two groups using the Terminated Block Randomization method with blocks of 4 and 6. Prescription drugs (intervention and control) are determined based on this method and a special number is assigned to them. The doctor and the patient do not know about receiving the drug or placebo. Codes have been recorded on the worm and only the epidemiologist as one of the plan's executors knows about it.
In the second phase of the study, the doctor knows the type of prescription and the patients are randomly entered into the study, and the topical cream as the main drug will be compared with routine drugs.
The first phase of the study is double blind and the second phase of the study is unblinded.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Intervention and control creams (Amphotericin B cream) are completely the same in terms of shape and container size. These creams also have no differences in terms of color and are completely unrecognizable. The important point is that the patient is told, which this topical cream used for patient may be a medicine or a control medicine. In blinding, both the doctor and the patient will be blinded.
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Placebo
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Used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-02-09, 1400/11/20
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1400.199
Health conditions studied
1
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Description of health condition studied
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Cutaneous leishmaniasis
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ICD-10 code
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B55.1
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ICD-10 code description
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Cutaneous leishmaniasis
Primary outcomes
1
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Description
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Complete healing of the lesion
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Timepoint
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On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment
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Method of measurement
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Based on measuring the diameter of the induration of the lesion using a caliper
Intervention groups
1
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Description
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Intervention group: The intervention group includes 75 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 gr of Hyoscyamus niger along with 2 gr of propolis is used for three weeks. The duration of the use 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.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group includes 75 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use 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. Amphotrypsin b is prepared and provided to the patients in the same tube as the intervention group.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The start of the access period will be 6 months after patent presentation or 12 months after article publication.
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To whom data/document is available
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The data will be available to researchers working in academic and scientific institutes.
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Under which criteria data/document could be used
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The data printed in the article is accessible.
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From where data/document is obtainable
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Moderator: Morteza Kosari
Email address: kosarimorteza12@gmail.com
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What processes are involved for a request to access data/document
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We will try to respond to researchers as soon as possible.
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Comments
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