Comparison of the effect of portulaca oleracea L. and foeniculum vulgare mill and vitex agnus castus L. with spironolactone and cyproterone compound on hirsutism on patient with polycystic ovary syndrome
The purpose of this study is Comparison of the effect of portulaca oleracea L. and foeniculum vulgare mill and vitex agnus castus L. with spironolactone and cyproterone compound on hirsutism on patient with polycystic ovary syndrome
inclusion criteria : in the age range of 18 to 40 years of age ; absence of chronic physical illness (other than polycystic ovary syndrome)
Exclusion criteria : history of specific drug use (effects on levels of hormones, blood glucose, insulin or hirsutism); previous history of diabetes, cardiovascular disease, thyroid disease .
This randomized study was performed on 128 polycystic ovary syndrome women. These patients will be randomly divided into control and test groups . The control group will receive spironolactone and cyproterone compound , and the group will receive the portulaca oleracea L. and foeniculum vulgare mill and vitex agnus castus L. The treatment is performed for six months, then based on the Ferriman-Gallway scoring system on hirsutism that evaluates the extent of hair growth in most sensitive areas of the hair and tests including FSH, LH, PRL, and DHEAS in the test and control group It takes place.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062121653N7
Registration date:2017-10-01, 1396/07/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-01, 1396/07/09
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2018-01-01, 1396/10/11
Expected recruitment end date
2019-12-30, 1398/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of portulaca oleracea L. and foeniculum vulgare mill and vitex agnus castus L. with spironolactone and cyproterone compound on hirsutism on patient with polycystic ovary syndrome
Public title
Comparison of the effect of portulaca oleracea L. and foeniculum vulgare mill and vitex agnus castus L. with spironolactone and cyproterone compound on hirsutism on patient with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :oral and written judgment for participation in the study; in the age range of 18 to 40 years of age ; absence of chronic physical illness (other than polycystic ovary syndrome), and mental illness or drug use In the long time, it has been the patient's own words.
Exclusion criteria : history of specific drug use (effects on levels of hormones, blood glucose, insulin or hirsutism); previous history of diabetes, cardiovascular disease, thyroid disease ; other surgical and internal diseases. They do not have PCOS cryptography.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
128
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
Jahrom University of Medical Sciences
Street address
Jahrom, Motahari Blvd. pardis building
City
jahrom
Postal code
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.JUMS.REC.1395.169
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
hirsutism
Timepoint
3 month
Method of measurement
Ferriman-Gallway Scoring system
Secondary outcomes
1
Description
free testosterone
Timepoint
3month
Method of measurement
mg/ml
2
Description
follicle-stimulating hormone
Timepoint
3 month
Method of measurement
mg/ml
3
Description
Luteinizing Hormone
Timepoint
3 month
Method of measurement
mg/ml
Intervention groups
1
Description
The herbal diet intervention group contains 6 capsules per 24 hours, each dose of each capsule is 550 mg, and each capsule contains 25% portulaca oleracea L.(137 mg) + 25% foeniculum vulgare mill (137 mg) + 50% vitex agnus castus L.(275 mg). The treatment is for 3 months.
Category
Treatment - Drugs
2
Description
To the control group, the spironolactone (one daily dose of 100 mg) and cyproterone compound (one tablet daily dose of 50 mg) are given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Peimanieh hospital
Full name of responsible person
Dr Athar Rasekh Jahromi
Street address
Peimanieh hospital, Valiasr street,Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Jahrom University of Medical Sciences
Full name of responsible person
Ramezani
Street address
Pardis, The end of Bulvar Professor Motahari, Jahrom .
City
Jahrom
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 ,Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohadeseh Karimi
Position
General practitioner
Other areas of specialty/work
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Postal code
Phone
+98 71 5422 7658
Fax
Email
mohadesehkarimi2318@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Obstetrician Gynecologist and Infertility
Other areas of specialty/work
Street address
Pardis building, Motahari Blvd. ,Jahrom
City
jahrom
Postal code
Phone
+98 71 5422 1040
Fax
Email
drrasekh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohadeseh Karimi
Position
General practitioner
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)