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The effect of Ginkgo biloba extract on sexual function of menopausal women

Protocol summary

Summary
The objective of this study is to assess the effect of Ginkgo biloba on sexual function in menopausal women referred to selected health centers related to Iran University of Medical Sciences 2010- 2011. In a triple- blind, placebo- controlled trial, 72 menopausal aged 50-60 years, will be recruited and fill "Sabbatsberg Sexual Rating Scale (SSRS) and personal characteristics" questionnaire, and will sign an Informed Consent from. Inclusion criteria: Not having physical and psychological diseases in women and their spouses, able to read an write, having coitus at least once in a month. Exclusion criteria: Not having sexual activity during the study, not using the drug under investigation for more than 7 days during study. The participants will be randomly divided in intervention and control groups (36 women in each group).The intervention group will receive Ginkgo biloba, 60 mg capsule, twice daily for one week and the control group will receive placebo capsule, at the same dose as the intervention group. If the women tolerate the capsules, they will continue receiving 240 mg (4 times in a day) for a month. After a month, Sabbatsberg Sexual Rating Scale Scores will be measured again, compared and analyzed in the two groups before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010192172N5
Registration date: 2010-11-17, 1389/08/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-11-17, 1389/08/26
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginkgo biloba extract on sexual function of menopausal women
Public title
The effect of Ginkgo biloba extract on sexual function in menopausal women referred to selected health centers related to Iran University of Medical Sciences 2010-2011
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not having physical and psychological diseases in women and their spouses, able to read an write, having coitus at least once in a month. Exclusion criteria: Not having sexual activity during the study, not using the drug under investigation for more than 7 days during the study
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing and Midwifery Faculty of Iran University of Medical Sciences
Street address
Rashid Yasami St. Valiaasr St.
City
Tehran
Postal code
1996713883
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
1744275

Health conditions studied

1

Description of health condition studied
Sexual function of menopausal women
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Sexual function in postmenopausal women
Timepoint
1 month
Method of measurement
personal characteristic and Sabbatsberg questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ginkgo biloba Capsules, two 60 Mg capsules during first week, then four 60 Mg capsules during next 24 days will use as oral during morning and night.
Category
Treatment - Drugs

2

Description
Control group: Placebo Capsules' content, will have mixed of chickpea wheat and flour shuck, two 60 Mg capsules during first week, then four 60 Mg capsules during next 24 days will use as oral during morning and night.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valfajr health and treatment center
Full name of responsible person
Bahare Lesani
Street address
Dastgheib St, Ostad moeen St, Tehran, Iran.
City
Tehran

2

Recruitment center
Name of recruitment center
Fazel health and treatment center
Full name of responsible person
Dr. Katayoon Seiffarahi
Street address
Abfazelab St, Abdolahzadeh St, Keshavarz Boulevard, Valiasr Square, Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Shahid Ghafari health and treatment
Full name of responsible person
Dr. Zahra Malayeri
Street address
Flowers Market, phase 2, Ekbatan Town,Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for reasearch, Iran University of Medical Sciences
Full name of responsible person
Dr. Saeid Abass Motevalain, Dr. Mazyar Moradie Lakea
Street address
Next to Milad Hospital, Hemat Highway,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reasearch, Iran 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
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Faculty Member & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave. zip code: 1919915375
City
Tehran
Postal code
1919915375
Phone
+98 21 8247 1000
Fax
+98 21 8877 3080
Email
staavoni@iums.ac.ir, staavoni14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Faculty Member & Researcher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave. zip code: 1919915375
City
Tehran
Postal code
1919915375
Phone
+98 21 8247 1111
Fax
+98 21 8877 3080
Email
staavoni@iums.ac.ir, staavoni14@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M. Sc In Medical Education, M.Sc in Midwifery Education, Faculty Member & Researcher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave. zip code: 1919915375
City
Tehran
Postal code
1919915375
Phone
+98 218247111
Fax
+98 21 8877 3080
Email
staavoni@iums.ac.ir, staavoni14@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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