Determining the effect of Ginseng on sexual dysfunction in menopausal women: a randomized controlled trial
Design
Two-armed randomized controlled trial. Conduct: This study will be conducted on 62 postmenopausal women ages 45-60 years old referring to community health centers in Tabriz. Eligible individuals who has Female Sexual Function Index (FSFI) score less than 28 at the initial evaluation will be included in the study. After obtaining written informed consent, they will complete questionnaires of quality of life, menopausal symptoms and demographic characteristics. Next, they will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4 and 6 and the allocation ratio of 1:1.
Settings and conduct
This study will be conducted on 62 postmenopausal women ages 45-60 years old referring to community health centers in Tabriz. The intervention group will receive Ginseng capsules and the control group will receive placebo capsules. Both groups will take drug or placebo twice a day for four weeks
Participants/Inclusion and exclusion criteria
inclusion criteria: Married women; Women aged between 45 and 60 years; Last menstruation period between 12 months and 10 years; Female Sexual Function Index (FSFI) score less than 28 at the initial evaluation.
Exclusion criteria: Coronary artery disease or other heart problems such as significant arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled hypertension; Blood pressure lower than 90/50 mmHg; A history of radical hysterectomy; Anatomical deformity of external genitalia; A history of cerebrovascular disease or central nervous system disease; A history of spinal cord injury or related surgery; Having liver disorder; Kidney dysfunction; Intake of medicine such as amlodipine, valerian, and lorazepam (which are known to have interactions with ginseng); History of hormonal treatment for sexual dysfunction during the past two weeks; A history of chemotherapy or pelvic radiation treatment; Sexual dysfunction which was caused by mental disease; Present use of Phytoestrogens and other complementary or herbal medicine; Post coital bleeding or spotting
Intervention groups
The intervention group will receive Ginseng capsules and the control group will receive placebo capsules.
Main outcome variables
The main outcome variables include sexual function that will be assessed by Female Sexual Function Index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N32
Registration date:2017-12-31, 1396/10/10
Registration timing:retrospective
Last update:2017-12-31, 1396/10/10
Update count:0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginseng on sexual dysfunction in menopausal women: a double blinded randomized control
Public title
The effect of Ginseng on sexual function in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
Women ages between 45 and 60 years
Last menstruation period between 12 months and 10 years
Female Sexual Function Index (FSFI) score less than 28 at the initial evaluation
Having sex at least two times per month.
incidence of menopause naturally not following surgery (hysterectomy)
Exclusion criteria:
Coronary artery disease or other heart problems such as significant arrhythmia
Uncontrolled diabetes mellitus
Uncontrolled hypertension
Blood pressure lower than 90/50 mmHg
A history of radical hysterectomy
Anatomical deformity of external genitalia
A history of cerebrovascular disease or central nervous system disease
A history of spinal cord injury or related surgery
Having liver disorder
Kidney dysfunction
Intake of medicine such as amlodipine, valerian, and lorazepam (which are known to have interactions with ginseng)
History of hormonal treatment for sexual dysfunction during the past two weeks
A history of chemotherapy or pelvic radiation treatment
Sexual dysfunction which was caused by mental disease
Present use of Phytoestrogens and other complementary or herbal medicine
Post coital bleeding or spotting
Age
From 45 years old to 60 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4 and 6 and the allocation ratio of 1:1. A person not involved in the sampling will generate allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and investigator will be blind completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
............
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.TBZMED.REC.1396.715
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual function
Timepoint
before and 4 weeks after intervention
Method of measurement
Female Sexual Function Index Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and 4 weeks after intervention
Method of measurement
Menopause Quality Of Life Questionnaire ( MENQOL)
2
Description
Menopausal Symptoms
Timepoint
Before and 4 weeks after intervention
Method of measurement
Greene scale
Intervention groups
1
Description
The intervention group will receive Ginseng capsule twice daily for 4 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive placebo capsule twice daily for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers of Tabriz
Full name of responsible person
Zahra Ghorbani
Street address
Tabriz's Community health centers
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Ghorbani
Position
Msc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
+98 41365706391
Fax
+98 41 3479 6969
Email
zoha.ghorb@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor/ PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor/ PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery., South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.