This clinical trial is a randomized , double-blind , parallel, placebo-controlled study on 50 patients 15 to 35 years old with mild to moderate hirsutism on the chin, upper lip, and the2 sides face that in the past 6 months cosmetic or pharmaceutical treatment for hirsutism are not received , and other hormonal disorders will be implemented .patients devided 2 groups that receive topical herbal cream containing Vitex and fennel or placebo for 2 times in day for 6 months randomly. Inclusion criteria is based on the Ferriman and Gallway score. Hair diameter, hair growth rate, and evaluation of individual improvement will be measured monthly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042812438N7
Registration date:2014-07-04, 1393/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij research center of medicinal herbs
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-06-22, 1395/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cream containing vitex agnus castus extract and foeniculum vulgare essential oil on mild and moderate hirsutism symptoms
Public title
The effect of cream contain Vitex and Fennel on hirsutism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:15-35 years old. mild and moderate hirsutism accordig to ferriman & gallway score
exclusion criteria : sever hirsutism. cosmetic or pharmaceutical treatment for hirsutism in 6 months past.pregnancy and lactation.hyperandrogenism.other hormonal disorders.
Age
From 15 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2014-06-17, 1393/03/27
Ethics committee reference number
1354/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Hirsutism
ICD-10 code
L68.0
ICD-10 code description
Hirsutism
Primary outcomes
1
Description
hair diameter
Timepoint
monthly until end of study
Method of measurement
micrometer
2
Description
hair growth rate
Timepoint
monthly until end of study
Method of measurement
shave interval
3
Description
self assesment
Timepoint
monthly until end of study
Method of measurement
VAS
Secondary outcomes
1
Description
grade of hirsutism
Timepoint
monthly until end of study
Method of measurement
ferriman and gallway
Intervention groups
1
Description
intervention group:routin treatment+ topical herbal cream 2 times in day.until 6 months
Category
Treatment - Drugs
2
Description
control group:routin treatment+ topical placebo cream 2 times in day.until 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr F.Foroozanfard office
Full name of responsible person
Dr.F.Foroozanfard
Street address
City
Kashan
2
Recruitment center
Name of recruitment center
Gynecology Clinic of Kashan University of Medical Science
Full name of responsible person
Dr. F Foroozanfard
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Foroozanfard
Position
OBS & GYN, IVF Fellowship, Assistant Professor
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
fatemehforoozanfard@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)