The goal of this study is to aseey the effect of Elaeagnus angustifolia flower capsule on female sexual desire and sexual hormons . In this study have participated 84 married women with age between 18 to 40 years old that have low sexxual desire that are randomly in two groups with Elaeagnus angustifolia flower capsul and control groups .Before and after of intervention, hormonal tests consist of total testestrone-free testestrone and DEHAS are examined. Elaeagnus angustifolia flower capsul dosage for each patient in day is 4/5 g in 2 divided doses (every 12 hours, two numbers) . The control group use placebo every 12 hours. Intervention period is 35 days. after that sexual desire and sexual satisfaction , Respectively are examined with Hurlbert desire index and Enrich questionnaire(short form).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212079818N2
Registration date:2012-12-24, 1391/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Sanaz Zeinalzadeh
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 3794
Email address
zinalzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office of Shiraz University Of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Elaeagnus angustifolia flower capsule to improvement of female sexual desire and sexual hormon in married 18-40 years old .
Public title
The effect of Elaeagnus angustifolia flower to improvement of female sexual desire and sexual hormon
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to participate; married woman with age between 18-40; not pregnant; not having breast feeding; No history of heart disease and vascular disease (the patient's medical records); No history of uncontrolled hypertension and hypotension; Not taking any medications that affect sexual function (specially common antidepressant);No history of hypothyroidism and hyperprolactenemia(check with tests). Exclusion criteria:taking hormone pills particulary OCP; taking alchohl or tobacco; history of active peptic ulcer disease ; history of headaches including migraines; history of dysparunia or vaginismus.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University Of Medical Sciences
Street address
Central department of Shiraz University Of Medical Sciences,Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2012-09-13, 1391/06/23
Ethics committee reference number
91-01-33-4439
Health conditions studied
1
Description of health condition studied
Lack or loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
female sexual desire
Timepoint
At the start of intervention- After intervention
Method of measurement
Herlbert Sexual desire Index Questionnaire
2
Description
Sexual satisfaction
Timepoint
At the start of intervention- After intervention
Method of measurement
Enrich marital satisfaction questionnaire
3
Description
Sexual hormons
Timepoint
At the start of intervention- After intervention
Method of measurement
tests
Secondary outcomes
1
Description
improvement of sexual desire
Timepoint
During the study and after completion of it
Method of measurement
During the study and after completion of it
Intervention groups
1
Description
intervention with Elaeagnus angustifolia flower capsule , for each person 4.5g in day BID (each 12 hours, 2 capsuls) for 35 days
Category
Treatment - Drugs
2
Description
placebo QID ( each 12 hours, 2 tab) for 35 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Health Center
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
DR. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
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, Shiraz 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
Fatemeh College of Nursing And Midwifery,Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
akbarzadehmarzieh@ yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery,Shiraz University of Medical Sciences
Full name of responsible person
marzieh akbarzadeh
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
akbarzadehmarzieh@ yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Sanaz Zeinalzadeh
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
zinalzadeh@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)