The aim of this randomized controlled trial ( double blind ) is to determine the effect of Foeniculum vulgare seed powder on estrogen levels, menopausal symptoms and sexual desire in menopausal women. We will recruit 70 cases of post menopausal women 45-60 years old at selected health care centers in gachsaran/Iran. Inclusion criteria inclusive the during the past 12 months have not been menstural periods; with minimum score of 15 in Kupperman Index. After getting written informed consent, participants will complete the demographic charactristics،Kupperman Index and Hullbert Index of Sexual Desire.Then we will randomly allocate them into intervention and control groups using permuted block randomization. One group receive fennel capsule (500mg for QID) and the other one receive placebo capsule for 8 weeks. The Kupperman Index and Hullbert Index of Sexual Desire (HISD) is evaluated before and after4, 8 weeks treatment again. Before and after the intervention by taking blood samples from participants to determine their estrogen levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022125566N4
Registration date:2016-03-23, 1395/01/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Maryam Hosseininik
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1334 6079
Email address
hosseininik.maryam@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Foeniculum vulgare seed powder on estrogen levels, menopausal symptoms and sexual desire in menopausal women
Public title
Effect of Foeniculum vulgare seed powder on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being married and between 40 and 60 years old ; During the past minimum of 12 months and maximum of 5 years have not been menstural periods; With minimum score of 15 in Kupperman Index;Did not recognize diagnosed with mental retardation and hearing and vision problems cognitive; Not received hormone therapy and diet or herbal treatment during the last 6 months ; Lack of chronic diseases (especially epilepsy)
Exclusion criteria: Migration;Chronic diseases that have an affected on outcome variables, Consumes less than 80 percent of the drugs in a month
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Yasuj University of Medical Science Yasuj
Street address
Motahary boulevard, Vice chancellor for research
City
Yasuj
Postal code
Approval date
2015-04-22, 1394/02/02
Ethics committee reference number
ir.yums.rec.1394.6
Health conditions studied
1
Description of health condition studied
Menopausal
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climactric states
Primary outcomes
1
Description
Estrogen levels
Timepoint
Before the intervention and Two months after the beginning intervention
Method of measurement
According ng / mL by ELISA sensitivity
2
Description
Symptoms of menopausal
Timepoint
Before the intervention, Four and eight weeks after the beginning intervention
Method of measurement
Kupperman index
3
Description
Sexual desire
Timepoint
Before the intervention, Four and eight weeks after the beginning intervention
Method of measurement
Hullbert Index of Sexual Desire (HISD)
Secondary outcomes
1
Description
Vasomotor symptoms
Timepoint
Before the intervention, Four and eight weeks after the beginning intervention
Method of measurement
Before the intervention, Four and eight weeks after the beginning intervention
Intervention groups
1
Description
4 caps of placebo, Every 6 Hours for 8 weeks
Category
Placebo
2
Description
4 500mg-caps of fennel, Every 6 Hours for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
health care centers in gachsaran
Full name of responsible person
Street address
City
gachsaran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Dr Abdul Mohammad Mousavi
Street address
Motahary boulevard, Vice chancellor for research, Yasuj University of Medical Science
City
Yasuj
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,Yasuj 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
Yasuj University of Medical Science
Full name of responsible person
Dr Nazafarin Hosseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Near the Imam Sajjad (AS), Campus Yasuj of Medical Science, the third floor, School of Nursing and Midwifery (R)
City
Yasuj
Postal code
Phone
+98 74 3223 4115
Fax
Email
hosseinichenar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr Nazafarin Hosseini Affiliated Organization name
Position
Assistant Professor
Other areas of specialty/work
Street address
Near the Imam Sajjad (AS), Campus Yasuj of Medical Science, the third floor, School of Nursing and Midwifery (R)
City
Yasuj
Postal code
Phone
+98 74 3223 4115
Fax
Email
hosseinichenar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Maryam Hosseininik
Position
Master Student in Public Health Tendency
Other areas of specialty/work
Street address
Near the Imam Sajjad (AS), Campus Yasuj of Medical Science, the third floor, School of Nursing and Midwifery (R)
City
Yasuj
Postal code
Phone
00
Fax
Email
m.hosseinin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)