Protocol summary
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Study aim
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Evaluating the efficacy of topical herbal cream 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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A randomized, double-blinded, sham controlled phase2 clinical trial with a parallel group design of 66 patients
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Settings and conduct
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The clinical part of this study is performed in the dermatology clinic of Al-Zahra hospital in Esfahan. 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.This clinical trial is randomized, double-blinded, controlled trial with a parallel group design of 66 patients.
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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 - Patients who have not received topical, oral, or injectable medications for the treatment of eczema in the past week -Lack of infection or malignancy at the site of treatment (no problem with closed wounds). Exclusion criteria include: Under 18 years- Pregnancy and lactation- Patients with other skin lesions - Patients taking systemic immunosuppressive drugs or biological drugs.
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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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Added total of final patients number
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181026041466N5
Registration date:
2020-09-27, 1399/07/06
Registration timing:
prospective
Last update:
2021-12-23, 1400/10/02
Update count:
1
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Registration date
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2020-09-27, 1399/07/06
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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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2020-10-06, 1399/07/15
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Expected recruitment end date
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2021-01-19, 1399/10/30
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Actual recruitment start date
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2020-10-06, 1399/07/15
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Actual recruitment end date
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2021-01-19, 1399/10/30
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Trial completion date
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2021-01-29, 1399/11/10
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Scientific title
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Clinical trial of efficacy of a herbal cream containing Fumaria officinalis and Silybum marianum in the treatment of eczema; Double-blind controled Trial.
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Public title
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Effect of topical herbal cream on 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:
18 years old Men and women or older
One or more eczema lesions
Patients who have not received topical, oral, or injectable medication for the treatment of eczema in the last week
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 12 years old
Pregnancy and lactation
Patients with other skin lesions
Patients taking immunosuppressive systemic drugs or biological drugs
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Age
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From 12 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
66
Actual sample size reached:
40
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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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2020-09-26, 1399/07/05
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Ethics committee reference number
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IR.AJUMS.REC.1399.487
Health conditions studied
1
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Description of health condition studied
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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 30 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 30 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 30 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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Intervention group: The group receiving the herbal cream made by a researcher at the Ahvaz pharmacy School in Iran, every night until healing.
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Category
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Treatment - Drugs
2
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Description
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Control group: The group receiving the Momtazone 0.1% cream manufactured by Kish Medifarm Company in Iran, applied for 3 weeks every night until they heal.
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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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Rayka raya teb co
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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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Private
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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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Industry
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