Evaluation of the efficacy of Tribulus Terrestris and lepidium Meyeni extracts on improvement of sexual interest in females
Design
Clinical trial with control and parallel groups, randomized and double blind
Settings and conduct
This clinical double blind trial is conducted on 60 female patients with reduced sexual interest referring to Ebne Sina and Imam Reza Hospitals in Mashhad who are randomly assigned to three groups through simple randomization where the participants and outcome assessors are unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Married women between 18 to 50 years old with lack of sexual interest based on DSM5; Normal pelvic examination; Normal breast examination in the past 2 month; no pregnancy and breastfeeding or not having menstruation for more than 2 months. Exclusion criteria : Hormonal or anatomical diseases which prevent orgasm; History of cancer or psychological disorders which are under treatment; Husband's sexual problem; No active plan for divorce
Intervention groups
Control group: In this group, patients receive one capsule of placebo drug one hour after one of the meals daily for one month. Intervention group 1: In this group, patients receive one capsule of Tribulus Terrestris extract (produced in the faculty of pharmacy) one hour after one of the meals daily for one month. Intervention group 2: In this group, patients receive one capsule of Lepidium Meyenii extract (produced in the faculty of pharmacy) one hour one of the meals daily for one month.
Main outcome variables
rate of sexual interest
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N33
Registration date:2020-06-03, 1399/03/14
Registration timing:registered_while_recruiting
Last update:2020-06-03, 1399/03/14
Update count:0
Registration date
2020-06-03, 1399/03/14
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-05, 1399/02/16
Expected recruitment end date
2020-11-06, 1399/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Tribulus Terrestris and Lepidium Meyeni extracts on improvement of sexual interest in females
Public title
The efficacy of the extracts of Tribulus Terrestris and Lepidium Meyeni on improvement of sexual interest in females
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women between 18 to 50 years old with lack of sexual interest based on DSM5 (who has satisfactory relationship with her husband and live with him at least 15 days in a month and is also sexually active)
Normal pelvic examination
Normal breast examination in the past 2 month
no pregnancy and breastfeeding
not having menstruation for more than two months
Exclusion criteria:
Hormonal or anatomical diseases which prevent orgasm such as diabetes, cerebrovascular diseases, liver-kidney-heart problems, hypothyroidism
History of cancer or psychological disorders which are under treatment such as breast and pelvic cancer or depression, anxiety and psychosis
husband's sexual problem
no active plan for divorce
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one patient and places her in one of the three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the the grouping. Patients in the control group receive placebo drug.
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
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.326
Health conditions studied
1
Description of health condition studied
sexual interest
ICD-10 code
F52.22
ICD-10 code description
Female sexual arousal disorder
Primary outcomes
1
Description
Rate of sexual interest
Timepoint
Before and at the end of the one -month treatment
Method of measurement
Administration of Arizona Sexual Experience Scale (ASEX)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients receive one capsule of Tribulus Terrestris extract (produced in the faculty of pharmacy) one hour after one of the meals daily for one month.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, patients receive one capsule of Lepidium Meyenii extract (produced in the faculty of pharmacy) one hour one of the meals daily for one month.
Category
Treatment - Drugs
3
Description
Control group: In this group, patients receive one capsule of placebo drug one hour one of the meals daily for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Mahdie Ghanbari
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
ghanbarim951@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ebnesina hospital
Full name of responsible person
Mahdie Ghanbari
Street address
Ebnesina hospital, Horre Ameli Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
ghanbarim951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
34591357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Manteghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina hospital, Horre Ameli Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
manteghia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Manteghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina hospital, Horre Ameli Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
manteghia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Manteghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina hospital, Horre Ameli Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
manteghia@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures.
Under which criteria data/document could be used
In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months