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The Effect Of Date Palm Pollen Capsul On Sexual Function In Menopausal Woman: A randomized controlled clinical trial.

Protocol summary

Summary
The aim of this Double blind randomized controlled trial is to determine the effect of Date Palm Pollen Capsule on sexual function in postmenopausal women. We will recruit 60 menopausal aged 50-60 years women from public health centers in Mashhad (2016), Iran. Inclusion criteria: Iranian women, Fifth grade of Elementary School, age 40-65 years for a research unit or her Spouse, Women with natural menopause, Married women and having sex at least once a month, desire to participate in the research. Exclusion criteria: Having any sexual dysfunction before menopause, Known medical conditions affecting sexual function in research unit or her Spouse, Research Unit or her Spouse have Consumption Drugs affecting sexual performance during the past three months, Experience some unpleasant or stressful life events in the past 6 months by the Research Unit or her Spouse, Research Unit have to be sensitive to pollen and medicinal plants, treated with hormonal drug, Research Unit or her Spouse addiction to drugs or alcohol. After getting written informed consent, participants will complete a self-administered questionnaire about demographic and reproductive history and also questions about Female Sexual Function Index (FSFI).The participants will be randomly divided in intervention and control groups (30 women in each group).The intervention group will receive Date Palm Pollen, 300 mg capsule, once daily for 5 week and the control group will receive placebo capsule, at the same dose as the intervention group. The participants will complete FSFI post -test questionnaires 5 weeks after intervention. The mean of difference in sexual function scores are compared among two groups. In this study we keep blinding for participants and researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070928853N1
Registration date: 2016-12-09, 1395/09/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Somaye Sadeghi Goghari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
sadeghis922@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-08-20, 1395/05/30
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Date Palm Pollen Capsul On Sexual Function In Menopausal Woman: A randomized controlled clinical trial.
Public title
The Effect Of Date Palm Pollen Capsul On Sexual Function In Menopausal Woman
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women, Fifth grade of Elementary School, age 40-65 years for a research unit or her Spouse, Women with natural menopause, Married women and having sex at least once a month, desire to participate in the research. Exclusion criteria: Having any sexual dysfunction before menopause, Known medical conditions affecting sexual function in research unit or her Spouse, Research Unit or her Spouse have Consumption Drugs affecting sexual performance during the past three months, Experience some unpleasant or stressful life events in the past 6 months by the Research Unit or her Spouse, Research Unit have to be sensitive to pollen and medicinal plants, treated with hormonal drug, Research Unit or her Spouse addiction to drugs or alcohol.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.MUMS.REC.1395.183

Health conditions studied

1

Description of health condition studied
Sexual Function In Menopausal Woman
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual Function
Timepoint
Before intervention and 35 day after taking the capsules.
Method of measurement
Female Sexual Function Index(FSFI)

Secondary outcomes

1

Description
Sexual Function
Timepoint
Before intervention and 35 day after taking the capsules.
Method of measurement
Femal Sex Function Index

Intervention groups

1

Description
Control group: be taken daily 300 mg placebo capsules for 35 days.
Category
Treatment - Drugs

2

Description
Interventional group: be taken daily 300 mg oral Date Palm Pollen capsules for 35 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Nejad Health and Treatment Center
Full name of responsible person
Somaye Sadeghi Goghari
Street address
Faculty of Nursing and Midwifery, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
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, Mashhad 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
Faculty of Nursing and Midwifery, Mashhad
Full name of responsible person
Somaye Sadeghi Goghari
Position
Instructor of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Crossroads Doktora, street Ebn Sina,Mashhad
City
Mashhad
Postal code
Phone
+98 917 575 0127
Fax
Email
Sadeghis922@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad
Full name of responsible person
Sedighe Yosef Zade
Position
Instructor of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Crossroads Doktora, street Ebn Sina,Mashhad
City
Mashhad
Postal code
Phone
+98 915 320 2371
Fax
Email
Yosefzadehs@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad
Full name of responsible person
Somaye Sadeghi Goghari
Position
Masters Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Crossroads Doktora, street Ebn Sina,Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
Sadeghis922@mums.ac.ir
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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