The purpose of this study is evaluate the efficacy of Rosa damascenes extracts in the treatment of sexual dysfunction in women. This is a triple-blind clinical trial. Research Environment is traditional medicine clinics and centers affiliated to Tehran University of Medical Sciences. Patients with diagnoses of sexual dysfunction, as well as the other criteria will be entered into the study. 80 married women referred to this centers were selected and randomly divided into two groups. The intervention group receive Soft capsule twice a day containing 15 mg of extract (standardized on the basis of at least 5/7 mg per capsule, soft citronellol) for 8 weeks. The control group received placebo. Placebo with similar appearance and only sesame oil or soybean oil would be, So that samples are unaware of the contents of the capsules. Then at the beginning of the study, four and eight week of the study, libido,sexual arousallevels, orgasmic disorders, sexual pain disorders and sexual satisfaction were examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051333951N1
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
mohadeseh motaharinezhad
Name of organization / entity
school of midwifery and nursing, Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 4301
Email address
motahari.m11@gmail.com
Recruitment status
Recruitment complete
Funding source
Barij Essence Pharmaceutical companies
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose oil essence on the sexual dysfunction of women
Public title
The effect of rose oil essence on the sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included all the married women have a stable life with wife, At least read and write, Not during pregnancy and lactation and menopause, Without having any chronic disease(self reported), Absence of mental illness known -Psychic(self reported), Non-hormonal drugs and drugs that affect sexual desire and performance(Such as antidepressants, aspirin and anticoagulants), According to the questionnaire, the Female Sexual Function Index (FSFI) questionnaire impaired sexual function, according to Beck (BDI) is a non-depressive illness, Is not a multi-partner, The lack of adverse events in at least 6 months, Lack of substance abuse and alcohol in a person and The absence of a partner's sexual dysfunction (premature ejaculation, erectile dysfunction) self-reported is.
Exclusion criteria included Not wanting to continue to participate in research, Lack of sex during the study, Drugs only affect sexual function during the study, Diagnosis of chronic disease and mental - mental in person during the period of study( self-reported), No drug or placebo for a week or more and Disasters like the loss of a spouse or close relative during the study period.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical science
Street address
Ghods St., Keshavarz Blvd.
City
tehran
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.TUMS.FNM.REC.1395.483
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 the intervention, 4 weeks after starting treatment and after the treatment at week 8
Method of measurement
FSFI Standardized questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Rosafeel Barij, soft capsule containing 15 mg of Rose essential oil (standard on the basis of at least 5/7 mg per capsule citronellol) twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Placebo, soft capsules, containing Sesame oil or soy, twice a day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadiyya clinic
Full name of responsible person
Dr Malihe tabaraei
Street address
Palestine Square North sarparast Street No. 27
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical companies
Full name of responsible person
Leyla taghizadeh
Street address
Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical companies
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
school of midwifery and nursing, Tehran university of medical science
Full name of responsible person
Mohadeseh motaharinezhad
Position
Post graduate student of midwifry
Other areas of specialty/work
Street address
Tohid squar, school of midwifery and nursing
City
Tehran
Postal code
Phone
+98 21 8879 4301
Fax
Email
motahari.m11@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
school of midwifery and nursing, Tehran university of medical science
Full name of responsible person
seyedeh tahereh mirmolaei
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Tohid squar, school of midwifery and nursing
City
Tehran
Postal code
Phone
+98 21 8879 4301
Fax
Email
Mirmolaei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
school of midwifery and nursing, Tehran university of medical science
Full name of responsible person
Mohadeseh motaharinezhad
Position
Post graduate student of midwifry
Other areas of specialty/work
Street address
Tohid squar, school of midwifery and nursing
City
Tehran
Postal code
Phone
+98 21 8879 4301
Fax
Email
motahari.m11@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)