Aim: Evaluation of efficacy of Tribulus teresteris on sexual response in women with reduced libido
Design: Reduced libido is a complaint of 30-50% in women. Despite its high prevalence, there are not enough studies about its management. Aside from hormonal therapy, there are no current FDA approved medical treatments for reduced libido in female patients.
Setting and conduct: Many herbal remedies have been used for reduced libido in women in the Iranian traditional medicine practice including Tribulus teresteris. Our study will evaluate this herbal remedy in such group of patients.
Participants: Inclusion criteria: Women with reduced libido; without any serious disease; with a recent normal pap smear (it coab be three months old); and normal vaginal and breast physical examination are the choice. Exclusion criteria: If the sexual partner is present less than half of the month; past medical history of breast or genital cancer and under therapy for depression or other physical or mental disorders.
Intervention: This is a double blind study comparing the herbal remedy with the placebo.The sample size is 60 women, who undergo an interview in the beginning ot the study to confirm their reduced libido according with DSM4 criteria.
Measures: Subsequently they fill FSFI (Female Sexual Function Index) questionnaire and receive the herbal remedy. The subjects will be seen 2 and 6 weeks after being on therapy. They fill the same questionnaire after being on treatment for 6 weeks.
FSFI questionnaire evaluate five elements: desire, arousal, satisfaction, orgasm and dysparonia. This study evaluate the effect of our herbal remedy Tribulus teresteris, on those five elements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111111425N1
Registration date:2012-12-03, 1391/09/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Elham Akhtari
Name of organization / entity
Tehran University of Medical Colledge
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 1305
Email address
e-akhtari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medicine
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Tribulus Teresteris in female sexual disorder in reproductive ages
Public title
Efficacy and safety of Tribulus teresteris in female sexual disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Fixed partner; Persistent or intermittent low libido; A normal pelvic examination; A normal pap smear; A normal breast examination.
Exclusion criteria: No fixed partner; A serious medical situation; History of genital or breast cancer; An under observed depression or other psychological disorders
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 traditional medicine university of Tehran medical college
Street address
Islamic medicinal research institute, Pirnia Ave., Lalehzar St., Tehran, Iran
City
Tehran
Postal code
Approval date
2012-11-12, 1391/08/22
Ethics committee reference number
847/م/ط/پ/26
Health conditions studied
1
Description of health condition studied
Female sexual disease
ICD-10 code
F-52
ICD-10 code description
Sexual dysfunction not caused by organic disorder or disease
Primary outcomes
1
Description
libido
Timepoint
At the begining of the trial, 7th day and one month after end of the drug
Method of measurement
FSFI questionaire
Secondary outcomes
1
Description
arousal
Timepoint
At the beginning of the study, 7 days after starting the drug and one month after finishing the drug
Method of measurement
FSFI questionnaire
2
Description
Desire
Timepoint
In the beginning of study, 7 days after it and 1 month after finishing the drug
Method of measurement
FSFI questionnaire
3
Description
Satisfaction
Timepoint
At the beginning of the study, 7days after it and 1 month after finishing the drug
Method of measurement
FSFI questionnaire
4
Description
Orgasm
Timepoint
At the beginning of the study, 7 days after it and 1 month after finishing the drug
Method of measurement
FSFI questionnaire
5
Description
Dysparonia
Timepoint
At the beginning of the study, 7 days after it and 1 month after finishing the drug
Method of measurement
FSFI questonnaire
Intervention groups
1
Description
In the drug group: a syrup from Tribulus extract, 7.5 cc, twice a day for 1 week
Category
Treatment - Drugs
2
Description
In control group:A placebo syrup, 7.5 cc, twice a day, for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Akhtari Elham
Street address
Behesht Ave., Vahdat e Eslami ST., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Dr. Minaei
Street address
Behesht Street, Vahdat eslami Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
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
Traditional Medicine Faculty of Tehran Medical Colledge
Full name of responsible person
Elham Akhtari
Position
PHD coarse
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
+98 21 2610 1305
Fax
Email
elham_akhtari@yahoo.com; e-akhtari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional Medicine of Tehran Medical Colledge
Full name of responsible person
Dr. Mansoor Keshavarz
Position
Associated professor
Other areas of specialty/work
Street address
Behesht Av.,Vahdat eslami St.,
City
Tehran
Postal code
Phone
+98 21 5563 9723
Fax
Email
mkeshavarz@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional medicine of Tehran medical colledge
Full name of responsible person
Elham Akhtari
Position
PHD student
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
+98 21 2610 1305
Fax
Email
elham_akhtari@yahoo.com; e-akhtari@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)