Determination of the efficacy of of anise oil cream 7% in treatment of patients with eczema
Design
Two arm parallel group randomized clinical trial, double blinded
Settings and conduct
Samples include the patients with hand eczema who refer to the Shahid Faghih Dermatology Clinic. In order to blind the investigator, medications are named as "A" for cream of anise oil and B for triamcinolone ointment. The patients were not aware of which drug they received. In addition, the groups are entered into statistical analysis as "A" and "B".
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Patient with chronic eczema of hand 2. Age between 18-60 years old 3. Patient Satisfaction to participate in the research project*** Exclusion criteria: 1. Pregnant and lactating women 2. Patients with infectious eczema 3. Use of topical medication in the last two weeks 4. Use of systemic steroids or other oral medication that for treatment the eczema in the last month 5. Positive history of allergy to herbal medicines 6. Patients with autoimmune diseases 7. Patients with hyper sensitivity disorders 8. Patients with other dermatology disorders 9. Patients with rheumatology disorders
Intervention groups
Group A: Use of topical product of anise twice daily for one month*** Group B: Use of topical triamcinolone twice daily for one month
Main outcome variables
Severity of hand eczema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N10
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of anise oil cream 7% in treatment of patients with eczema: a randomized controlled clinical trial
Public title
Evaluation of the effect of anise oil cream 7% in treatment of patients with eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with chronic eczema of hand
Age between 18-60 years old
Patient Satisfaction to participate in the research project
Exclusion criteria:
Pregnant and lactating women
Patients with infectious eczema
Use of topical medication in the last two weeks
Use of systemic steroids or other Oral medication that for treatment the eczema in the last month
History of allergy to herbal medicines
Patients with autoimmune diseases
Patients with hyper sensitivity disorders
Patients with other dermatology disorders
Patients with rheumatology disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink was used to create a randomization table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the investigator, medications were named A ( anise cream) and B (triamcinolone ). The patients were not aware of which drug they received. The groups were also coded A and B to the statistical analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School of Shiraz University of Medical Sciences
Street address
Medical School of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-08-07, 1397/05/16
Ethics committee reference number
IR.SUMS.MED.REC.1397.205
Health conditions studied
1
Description of health condition studied
Eczema
ICD-10 code
L23.9
ICD-10 code description
Allergic contact dermatitis, unspecified cause
Primary outcomes
1
Description
Severity of eczema
Timepoint
Assessment the severity of eczema at the start of the study, one month after beginning the treatment, and one month after discontinue the treatment
Method of measurement
Use of Eczema Area and Severity Index (EASI score)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of topical product of anise twice daily for one month
Category
Treatment - Drugs
2
Description
Control group: Use of topical triamcinolone twice daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Street address
Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 9983
Email
pasalar@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Medical School of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 9983
Email
pasalar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Medical School of Shiraz University of Medical Sciences, Zand Avenue
City
Fars
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 9983
Email
pasalar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Faghihi Hospital, Molecular Dermatology Research center, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document