40 patients with Hyperandrogenism were randomly divided into two equal groups.The first group will receive nettle root extract, 600-300 mg daily in three divided doses and the second group will be used as the standard treatment. Serum levels of total and free testosterone, DHEA also be determined before treatment in both groups.The patients will use dry extract of nettle root and the standard treatment by 4 months. at the end of treatment serum levels of total and free testosterone, DHEA will be rechecked.Hyperandrogenism symptoms such as acne, Status of patients mense,oily skin is assessed via questionnaire before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061013612N1
Registration date:2013-08-08, 1392/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-08, 1392/05/17
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
All cost of this project will be funded by the bone Research Center of Tabriz University of Medical Sciences .
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-10-07, 1392/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of stinging nettle (Urtica dioica) in women with hyperandrogenism
Public title
Therapeutic effects of Stinging Nettle (Urtica dioica)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with hyperandrogenism ; ages between 15-50 Exclusion criteria: The period of lactation ; pregnancy
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Univesity of Medical Sciences
Street address
Central Construction of University ,Street of University , Tabriz Univesity of Medical Sciences
City
Tabriz
Postal code
51665-118
Approval date
2013-05-13, 1392/02/23
Ethics committee reference number
5/4/1995
Health conditions studied
1
Description of health condition studied
Hyperandrogenism
ICD-10 code
E28.1
ICD-10 code description
Hypersecretion of Ovarian Androgens
Primary outcomes
1
Description
Serum level of free Testestrone
Timepoint
Before study and after 4 months
Method of measurement
Lab test , ng/dl
2
Description
serum level of total Testestrone
Timepoint
Before study and after 4 months
Method of measurement
Lab test , ng/dl
3
Description
serum level of DHEA
Timepoint
Before study and after 4 months
Method of measurement
Lab test , ng/dl
Secondary outcomes
1
Description
Edema
Timepoint
Every month
Method of measurement
History and Examination
2
Description
Gastrointestinal Complaints
Timepoint
Every month
Method of measurement
History and Examination
3
Description
Decreased urine volume
Timepoint
Every month
Method of measurement
History and Examination
Intervention groups
1
Description
In first group, the serum levels of free and total testosterone and DHEA is measured , then they take 300-600 mg 0f extracted dry nettle root daily for 4 months . After 4 months the serum levels of total and free testosteroneand DHEA is measured.As well as oily skin and acne and mense of patients will be assessed through a questionnaire before and after treatment.
Category
Treatment - Drugs
2
Description
In second group, the serum levels of free and total testosterone and DHEA are measured.Then they take the routine treatment of Hyperandrogenism (spironolactone100mg daily ,cyproterone compound 100mg daily) for 4 months . After 4 months the serum levels of total and free testosteroneand DHEA is measured.As well as oily skin and acne and mense of patients will be assessed through a questionnaire before and after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Imam Reza Hospital
Full name of responsible person
Ali Niko
Street address
Shayan Mehr Residential Complex , Resalat Street , Tabriz , IRAN
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bone Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bone Research Center, Tabriz 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
Bone Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
5165685783
Phone
+98 41 1337 4531
Fax
Email
Farzad278@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bone research center ,Tabriz university of medical sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
5165685783
Phone
+98 41 1337 4531
Fax
Email
Farzad278@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bone Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
5165685783
Phone
+98 41 1337 4531
Fax
Email
Farzad278@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)