The aim of this study was to determine the effect of consumption of hydro alcohol extract on desire, excitement, sexual satisfaction and orgasm in postmenopausal women. This is a double-blind clinical trial, which is referred to Ahvaz Health Center No. 1 in order to collect samples. samples of this study are among postmenopausal women. The sample size is 120 people who are randomly assigned to four groups of 30 people. Inclusion criteria: being married and gaining sexual function score less than 26.5 and exclusion criteria are body mass index of 30 or higher, and use of hormone therapy during the past 2 months .The samples will be asked to questionnaires of demographic information, sexual function and sexual satisfaction to complete. Drugs by third-party packaged and coded and randomly placed at the disposal of the samples. Tribulus terrestris extract syrup into three groups containing concentrations of 0.5 and 0.7 and 0.9 or to a placebo group is that each person should take two tablespoons daily for two months. After 4 weeks and again at the end of the second month questionnaires were distributed, and the total score evaluated and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121131340N1
Registration date:2017-07-23, 1396/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Mina Shojaee
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
shojaee.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-03-30, 1396/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of hydro alcohol extract of teribulus terisris on sexual function and satisfaction in post menopausal women
Public title
Tribulus terrestris effect on satisfuction and sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:Postmenopausal women; reading and writing skills
Exclusion Criteria:BMI 30 or higher; use of hormone therapy
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
using Random number table method for this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.519
Health conditions studied
1
Description of health condition studied
sexual dys function
ICD-10 code
F52.0
ICD-10 code description
Either the prospect of sexual interaction produces sufficient fear or anxiety that sexual activity is avoided (sexual aversion) or sexual responses occur normally and orgasm is experienced but there is a lack of appropriate pleasure (lack of sexual enjoym
Primary outcomes
1
Description
Sexual Function
Timepoint
Before intervention,After 4 weeks and After 2 months
Method of measurement
FSFI Questionnaire
2
Description
Sexual Satisfaction
Timepoint
Before intervention,After 4 weeks and After 2 months
Method of measurement
Larenson Questionnaire
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Intervention group 3:The Extract of HydroAlcolol of Teribulus Teristris, Syrup in 0.9 mg/dl Twice per day in 2 months
Category
Treatment - Drugs
2
Description
Control group: syrups containing mannitol concentration of 0.5 Mg dl, twice a day for two months
Category
Treatment - Drugs
3
Description
Intervention group 1:The Extract of HydroAlcolol of Teribulus Teristris, Syrup in 0.5 mg/dl Twice per day in 2 months
Category
Treatment - Drugs
4
Description
Intervention group 2:The Extract of HydroAlcolol of Teribulus Teristris, Syrup in 0.7 mg/dl Twice per day in 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1 city of Ahvaz
Full name of responsible person
Mina Shojaee
Street address
Sheikh Bahai South Ave, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences ,vice chancellor for research
Full name of responsible person
Mina Shojaee
Street address
Golestan Ave, Ahvaz, Khozestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences ,vice chancellor for research
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina shojaee
Position
Midwifery student
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 5335 1538
Fax
Email
m.shojaee@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mina shojaee
Position
Midwifery student
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 61 5335 1538
Fax
Email
m.shojaee@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
mina shojaee
Position
Midwifery student
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)