Protocol summary
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Study aim
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Evaluating the efficacy of topical cream based on Iranian traditional medicine containing Tragacanth, White wax and Bitter almond oil on the symptoms management of Eczema (clinical study) and it’s comparison with Mometasone 0.1%
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Design
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The study design is an intervention, randomized to intervention and control groups, double-blind and phase 3 clinical trials.
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Settings and conduct
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The clinical part of this study is performed in the general clinic of Razi dermatology hospital in Tehran.
The blinding of the study is done in a way that the containers are labeled by the researcher, and patients are initially told that when you participate in the project, you are randomly given a herbal or chemical cream, so the patient is And the doctor is not aware of the consumed content. The data is also shown to Code Specialist A through Code B to blind him to the research.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include:
- Men and women 18 years or older
- One or more eczema lesions in the palm or back area
- Mild to moderate plaques
- Patients who have not received topical, oral, or injectable medications for the treatment of eczema in the past week (emulsion use was permitted).
Lack of infection or malignancy at the site of treatment (no problem with closed wounds).
- Patient's consent to participate in the study
Exclusion criteria include:
- Under 18 years
Pregnancy and lactation
Whole body eczema
- Patients with other skin lesions
- Taking other topical medicines while participating in research
Patients taking systemic immunosuppressive drugs or biological drugs.
Infection or skin malignancy at the treatment site
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Intervention groups
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Herbal cream (intervention group) or mometasone cream (control group)
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Main outcome variables
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There will be no consequences for the participants.
General information
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Reason for update
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Edit information after completing the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190914044767N1
Registration date:
2019-12-19, 1398/09/28
Registration timing:
prospective
Last update:
2024-09-20, 1403/06/30
Update count:
1
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Registration date
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2019-12-19, 1398/09/28
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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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2019-12-21, 1398/09/30
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Expected recruitment end date
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2020-01-04, 1398/10/14
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Actual recruitment start date
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2019-12-23, 1398/10/02
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Actual recruitment end date
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2020-02-03, 1398/11/14
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Trial completion date
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2020-02-26, 1398/12/07
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Scientific title
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Evaluating the efficacy of topical cream based on Iranian traditional medicine containing Tragacanth, White wax and Bitter almond oil on the symptoms management of Eczema (clinical study) and it’s comparison with Mometasone 0.1%
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Public title
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Effect of topical cream ,containing Tragacanth on the Eczema and it’s comparison with Mometasone 0.1%
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men and women 18 years or older
One or more eczema lesions in the palm or back area
Mild to moderate plaques
Patients who have not received topical, oral, or injectable medication for the treatment of eczema in the last week (emulsion use is permitted).
Lack of infection or malignancy at the treatment site (no problem with closed wounds).
Patient's consent to participate in the study
Exclusion criteria:
Under 18 years
Pregnancy and lactation
Eczema generalize
Patients with other skin lesions
Taking other topical medicines while participating in the research
Patients taking immunosuppressive systemic drugs or biological drugs.
Infection or skin malignancy at the treatment site
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Age
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From 18 years old to 99 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
42
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed in a randomized, individualized, block with statistical software. The randomization list is available to the researcher. and given to the participants, according to the order of the herbal cream (intervention group) or the mometasone cream (control group). The herbal cream containers are labeled blue and the mometasone cream containers are labeled red; shown in the randomization list in letters A and B, respectively.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The blinding of the study is done in a way that the labels of the medicine containers are labeled by the researcher, and patients are initially told that when you participate in the project, you are randomly given a herbal or chemical cream, so Patient and physician are not aware of consumed content. The data is also shown to the data analyzer by code A and B.
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Placebo
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Not used
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Assignment
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Factorial
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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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2018-12-30, 1397/10/09
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Ethics committee reference number
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IR.IAU.PS.REC.1397.354
2
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Ethics committee
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Approval date
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2019-09-01, 1398/06/10
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1398.192
Health conditions studied
1
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Description of health condition studied
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Mild to moderate hand eczema
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ICD-10 code
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L20
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ICD-10 code description
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Atopic dermatitis
Primary outcomes
1
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Description
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Atopic dermatitis disease intensity
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Timepoint
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At the beginning of the study and about 20 days after starting the topical cream (after treatment)
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Method of measurement
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SCORAD Index form
2
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Description
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Duration of recovery
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Timepoint
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About 20 days after starting the topical cream (after treatment)
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Method of measurement
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Patient Tracking and Evaluation with SCORAD and DLQI
Secondary outcomes
1
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Description
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Quality of dermatology patient's life
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Timepoint
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At the beginning of the study and about 20 days after starting the topical cream (after treatment)
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Method of measurement
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DLQI questionnaire
Intervention groups
1
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Description
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Control group: The group receiving the cream is Momtazone 0.1% manufactured by Kish Medifarm Company in Iran. The cream is applied for 3 weeks every night and then for 2 weeks every other night until they heal.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: The group receiving the cream consists of a tragacanth made by a researcher at the Shahid Beheshti Traditional School of Medicine Laboratory in Iran, applied the cream every night until healing.
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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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Traditional Medicine & Materia Medica Research center Shahid Beheshti university of Medical Sciences
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Proportion provided by this source
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100
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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