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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General information
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40
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2020-10-06, 1399/07/15
2020-10-06 00:00:00
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2021-01-19, 1399/10/30
2021-01-19 00:00:00
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2021-01-29, 1399/11/10
2021-01-29 00:00:00
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Added total of final patients number
Added total of final patients number
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اضافه شدن تعداد بیماران نهایی
اضافه شدن تعداد بیماران نهایی
Protocol summary
Study aim
Evaluating the efficacy of topical herbal cream on the symptoms management of Eczema (clinical study) and it’s comparison with Mometasone 0.1%
Design
A randomized, double-blinded, sham controlled phase2 clinical trial with a parallel group design of 66 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Herbal cream (intervention group) or mometasone cream (control group)
Main outcome variables
There will be no consequences for the participants.
General information
Reason for update
Added total of final patients number
Acronym
IRCT registration information
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
Registration date
2020-09-27, 1399/07/06
Registrant information
Name
Ali Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 8149
Email address
ali.aghaei110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
2020-10-06, 1399/07/15
Actual recruitment end date
2021-01-19, 1399/10/30
Trial completion date
2021-01-29, 1399/11/10
Scientific title
Clinical trial of efficacy of a herbal cream containing Fumaria officinalis and Silybum marianum in the treatment of eczema; Double-blind controled Trial.
Public title
Effect of topical herbal cream on Eczema and it’s comparison with Mometasone 0.1%
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 12 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
66
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.AJUMS.REC.1399.487
Health conditions studied
1
Description of health condition studied
Eczema
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Atopic dermatitis disease intensity
Timepoint
At the beginning of the study and about 30 days after starting the topical cream (after treatment)
Method of measurement
SCORAD Index form
2
Description
Duration of recovery
Timepoint
About 30 days after starting the topical cream (after treatment)
Method of measurement
Patient Tracking and Evaluation with SCORAD and DLQI
Secondary outcomes
1
Description
Quality of dermatology patient's life
Timepoint
At the beginning of the study and about 30 days after starting the topical cream (after treatment)
Method of measurement
DLQI questionnaire
Intervention groups
1
Description
Intervention group: The group receiving the herbal cream made by a researcher at the Ahvaz pharmacy School in Iran, every night until healing.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fariba Iraji
Street address
Alzahra Hospital, Soffeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8179604891
Phone
+98 31 3785 0842
Email
Alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rayka raya teb co
Full name of responsible person
Ali aghaei
Street address
Ansar, Koote abdollah.
City
ََAhvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 8149
Email
ali.aghaei110@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rayka raya teb co
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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali ََAghaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ahvaz Jundishapur University of medical Sciences, Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6155883964
Phone
+98 916 100 1172
Email
Ali.Aghaei110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali ََAghaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ahvaz Jundishapur University of medical Sciences, Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6155883964
Phone
+98 916 100 1172
Email
Ali.Aghaei110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali ََAghaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ahvaz Jundishapur University of medical Sciences, Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6155883964
Phone
+98 916 100 1172
Email
Ali.Aghaei110@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
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