evaluation the efficacy of itrifal saghir on head sebum production in seborrheic patients reffering to dermatology clinic of tehran imam khomeiny hospital in comparison with placebo .
Goal: correction the basic etiology of seborrhea from the perspective of persian traditional medicine which is distemperment wet & warm of the stomach.
inclusion criteria:؛patients aged 14 to 50 years suffering from scalp seborrhea.
exclusion criteria: pregnancy؛breast feeding؛patients with auto immune disease؛patients with any kind of cancer؛presence of seborrheic dermatitis sings on head؛using oral and topical drugs for treating seborrhea from 4 and 2 weeks before joining the research.
sample size: 44 persons in each group of drug and placebo.
The study population: sufferers from scalp seborrhea according to inclusion and exclusion criteria referred to the dermatology clinic of skin & stem cell research center and dermatology clinic of imam khomeiny hospital.
Intervention: itrifal saghir and wheat flour in 1 gr. capsules.B.D. for 2 months.
Out come: changing in mean scalp sebum secretion.Measuring with sebumeter in 0، 4weaks and 8weaks periods from starting the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070218332N1
Registration date:2015-06-17, 1394/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-06-17, 1394/03/27
Registrant information
Name
Elham Zareie
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 9276
Email address
zareiehms1@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Expected recruitment start date
2015-06-02, 1394/03/12
Expected recruitment end date
2015-12-13, 1394/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the efficacy of itrifal saghir on head sebum production in seborrheic patients reffering to dermatology clinic of tehran imam khomeiny hospital in comparison with placebo .
Public title
effect of itrifal saghir on scalp seborrhea
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:؛patients aged 14 to 50 years suffering from scalp seborrhea.
exclusion criteria: pregnancy؛breast feeding؛patients with auto immune disease؛patients with any kind of cancer؛presence of seborrheic dermatitis sings on head؛using oral and topical drugs for treating seborrhea from 4 and 2 weeks before joining the research.
Age
From 14 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee,Yazd Shahid Sadoughei Univesity of Medical Sciences
Street address
Central department of Shahid Sadoughei Medical University, Shahid bahonar squer, Yazd
City
yazd
Postal code
8916978477
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
65406\1\17\پ
Health conditions studied
1
Description of health condition studied
scalp seborrhea
ICD-10 code
L21.0
ICD-10 code description
seborrhoea capitis
Primary outcomes
1
Description
mean scalp skin sebum measured by sebumeter
Timepoint
0-week 4-week 8
Method of measurement
sebumeter-unit: μg/cm2
Secondary outcomes
empty
Intervention groups
1
Description
Placebo:
wheat flour.Filled in 1 gr capsules.
Category
Treatment - Drugs
2
Description
drug:
Itrifal saghir.Filled in 1gr capsules.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Imam khomeini hospital
Full name of responsible person
Dr.Elham Zareie
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Drematology clinic of skin & stem cell research center depended to Tehran univercity of medical sien
Full name of responsible person
Dr.Elham Zareie
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Central Building of Shahid Sadoughei Medical University, Shahid Bahonar squer,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Traditional Medicine Faculty of Ardakan, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr.Elham Zareie
Position
Phd student
Other areas of specialty/work
Street address
Imam Khomeini ave.Ardakan.Yazd
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
zareiehms1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin & Stem cell Research Center
Full name of responsible person
Dr.Parvin Mansouri
Position
Professor of Tehran University of medical siences. dermatologist