Determining the effect of black seed-extracted oil on the sexual function of women
Design
The study consists of one group and the intervention is the same for all. The study design is applied phase-two research in the field of clinical science. In addition, the sample size is 40 pepole.
Settings and conduct
The objective of this intervention is to investigate the effect of a combinatory medication on the basis of black seed on the sexual function of women.
Location of research: Ahmadieh Health Center in Tehran University of Medical Sciences.
examination session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women with a stable life with their spouse, having the least reading and writing education skills, having intercourse of three times or more during the study.
Exclusion criteria: Diagnosis of chronic physical, psychological and behavioral illnesses, being multi-partner, using hormonal drugs and drugs affecting sexual function, pregnancy, lactation, and menopause.
Intervention groups
40 women with an age range of 18- 35 years with sexual dysfunction are selected for the study. Medication it is used locally every night before bedtime, and once before intercourse in the area of the sex organs, inguinal area, low back, and soles. The duration of the intervention period is 14 days.
Main outcome variables
Score of sexual function; sexual desire or interest; satisfied in sexual relationship; sexual arousal; maintain vaginal lubrication until completion of intercourse based on FSFI questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190527043729N1
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
leila ghanbaryan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 2978
Email address
l-ghanbaryan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Topical effect an oil, derived from black seed, on women's sexual function: A pilot clinical trial
Public title
effect of a combinatory medication on the basis of black seed on the sexual function of women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with a stable life with their spouse
having the least reading and writing education skills.
having intercourse of three times or more during the study.
Exclusion criteria:
Diagnosis of chronic physical, psychological and behavioral illnesses.
being multi-partner
using hormonal drugs and drugs affecting sexual function.
pregnancy, lactation, and menopause.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Scienes
Street address
Alborz University of Medical Sciences, Official Town, North Taleghani Blvd.
City
KARAJ
Province
Alborz
Postal code
3149779453
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.ABZUMS.REC.1398.003
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
2
Description of health condition studied
Lack or loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
3
Description of health condition studied
Lack or loss of sexual enjoyment
ICD-10 code
F52.1
ICD-10 code description
Sexual aversion disorder
4
Description of health condition studied
Lack or loss of female sexual arousal disorder
ICD-10 code
F52.22
ICD-10 code description
Female sexual arousal disorder
Primary outcomes
1
Description
Score of sexual function based on Female sexual function index questionnaire
Timepoint
Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day, After starting the oil based on black seed
Method of measurement
Female sexual function index questionnaire
2
Description
Score of sexual desire or interest based on Female sexual function index questionnaire
Timepoint
Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day, After starting the oil based on black seed.
Method of measurement
Female sexual function index questionnaire
3
Description
Score of satisfied in sexual relationship based on Female sexual function index questionnaire
Timepoint
Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day, After starting the oil based on black seed.
Method of measurement
Female sexual function index questionnaire
4
Description
Score of sexual arousal based on Female sexual function index questionnaire
Timepoint
Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day, After starting the oil based on black seed.
Method of measurement
Female sexual function index questionnaire
5
Description
Score of maintain vaginal lubrication until completion of intercourse based on Female sexual function index questionnaire
Timepoint
Measurement of sexual function at the time of entering the study (before intervention), on the seventh day, and on the 14th day, After starting the oil based on black seed.
Method of measurement
Female sexual function index questionnaire
Secondary outcomes
1
Description
Skin itching
Timepoint
On the seventh day, and on the 14th day, After starting the oil based on black seed
Method of measurement
Observation
2
Description
Skin irritation
Timepoint
On the seventh day, and on the 14th day, After starting the oil based on black seed
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: The study consists of one group and the intervention is the same for all. 40 women with an age range of 18- 35 years with sexual dysfunction are selected for the study, according to inclusion and non-inclusion criteria. The duration of the intervention period is 14 days. In order to evaluate the patients, the female sexual function index (FSFI) is completed during each examination session. in the first and second stage, they will receive medication. the name of the medicinal product: olibanum oil. product description: a topical product based on black seed oil containing olibanum and olive oil. Company Name: Amir herbal medicine. Medication instructions for use: The medication is used locally every night before bedtime, and once before intercourse in the area of the sex organs, inguinal area, low back, and soles. Time of drug use: from the 14th day of the menstrual bleeding cycle, the nights before bedtime for 14 days and, once before any Sexual Intercourse.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadieh Iranian Medicine Health Center in Tehran University of Medical Sciences.
Full name of responsible person
Tabarrai Malihe
Street address
No. 27, Tbriz Line, North Sarparast Ave., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8839 2558
Fax
+98 21 8899 1829
Email
spm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Noori Sepehr Mohammad
Street address
Assistant Professor of Research and Technology,Alborz University of Medical Sciences, Saffarian Line, 45 Yards Golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3464 4255
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Tehran University of Medical Sciences
Full name of responsible person
Leila Ghanbaryan
Position
PHD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 68, Milad Line, Edalat Ave.,
City
Behbahan
Province
Khouzestan
Postal code
6361778538
Phone
+98 61 5283 2978
Email
lghanbaryan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirzad Meysam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Sarparast Ave., Taleghni St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4535
Email
shirzadmd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Shirbeigi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Ahmadieh Clinic, Sarparast ave., Taleghni ave.,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8801 0446
Email
l.shirbeigi@yahoo.com
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 potential data can be shared after being unidentified.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
Data will only be available for use in research articles and will not be publicly available in any other way.
From where data/document is obtainable
Please refer to the Faculty of Traditional Medicine of Tehran University of Medical Sciences for documentation and data.
Dr. Meysam Shirzad, Assistant Professor, Department of Iranian Medicine.
address: no 27., Sarparast Ave., taleghni Ave.
Contact number: 02188974535
Electric mail: shirzadmd@gmail.com
What processes are involved for a request to access data/document
The data will be available from the time the application is filed to the person responsible for the scientific evidence of the person requesting that the researcher working in the university and the study of the relevant study.