Consideration of the effect of Artemisia absinthium L. on eye darkness; a double blind randomized clinical trial
Design
Randomized double blind with parallel control group clinical trial
Settings and conduct
In Center for Research and Training in Skin Diseases And Leprosy, randomized double blind clinical trial will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1)Suffering from eye darkness
2)Interesting to participate in this study
3)Age 18-65 both sexes
4)Suffering from eye darkness more than 6 month
Exclusion criteria:
1)Pregnancy
2)lactation
3)Use of pilling procedure during the 6 last month
4)Use of microdermabrasion and laser 3 months prior to the study
5)Use of laser 3 months prior to the study
6)Use of solarium or sunbathing and sunburn 3 months prior to the study
5)Documented allergies to components of this cream
6)Use of drugs for skin diseases.
Intervention groups
Using cream with active component
Using placebo eye cream without active component as control
Main outcome variables
Reduction of eye darkness will be detected with physical examination an Mexameter.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043259N1
Registration date:2019-11-03, 1398/08/12
Registration timing:retrospective
Last update:2019-11-03, 1398/08/12
Update count:0
Registration date
2019-11-03, 1398/08/12
Registrant information
Name
Hanan Hamdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 5556
Email address
hamdi.h@kar.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Consideration of the effect of an eye cream Artemisia absinthium L. on eye darkness; a double blind randomized clinical trial
Public title
Consideration of the effect of Artemisia absinthium on eye darkness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from eye darkness
Interesting to participate in this study
Age 18-65 both sexes
Suffering from eye darkness more than 6 month
Exclusion criteria:
Lactation
pregnancy
Use of solarium or sunbathing and sunburn 3 months prior to the study
History of laser treatment or dermabrasion or deep facial peels within the past 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
According to the sample size of 30 people in each group, based on the randomized block design, 6 blocks with ten sizes were generated using the program at the following address.
The information of each block is sorted in a separate pocket and don’t open sooner. Based on this allocation B symbol is related treatment and A symbol is related control.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind clinical trial, which volunteers and researcher are blind about recognition of the cream. blindness is based on packaging and labeling by a Colleague of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs-Tehran university of Medical Sciences
Street address
VCR-6th floor-The Central Organization Of University- Qods Street- Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.TUMS.VCR.REC.1398.017
Health conditions studied
1
Description of health condition studied
Eye darkness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of darkness after using the medication
Timepoint
At the first- 2 weeks-4 weeks- 8 weeks
Method of measurement
Examination by physician- Test by Mexameter divice
Secondary outcomes
empty
Intervention groups
1
Description
1-Intervention group: 30 member volunteer for a 2 month period, apply twice, daily, eye cream (made in the Faculty Of Traditional Medicine) , In small quantities, which has Absinthium extract.
Category
Treatment - Drugs
2
Description
Control group: 2- Control group: 30 member volunteer for a 2 month period, apply twice, daily, eye cream(made in the Faculty Of Traditional Medicine), In small quantities, without Absinthium extract. No more act needed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadie Health center
Full name of responsible person
Hanan Hamdi
Street address
No 27-North Sarparast street- Taleqhni Street- Tehran
City
Tehran
Province
Tehran
Postal code
1416663371
Phone
+98 21 8833 5636
Email
SPM@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanan Hanan
Street address
No 27-North Sarparast Street- Taleqhni Street- Tehran
City
Tehran
Province
Tehran
Postal code
1416663371
Phone
+98 21 8899 5636
Email
SPM@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hanan Hamdi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 27-North Sarparast Street- Taleqhni Street- Tehran
City
Tehran
Province
Tehran
Postal code
1416663371
Phone
+98 21 8899 5636
Email
hamdi.h@kar.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanan Hamdi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 27-North Sarparast Street- Taleqhni Street- Tehran
City
Tehran
Province
Tehran
Postal code
1416663371
Phone
+98 21 8899 5636
Email
hamdi.h@kar.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanan Hamdi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 27-North Sarparast Street- Taleqhni Street- Tehran
City
Tehran
Province
Tehran
Postal code
1416663371
Phone
+98 21 8833 5636
Email
hanan129@yahoo.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