Determining of the Effect of Iranian Carrot Syrup (Parsnip) on Female Sexual Dysfunction
Design
This clinical trial study was triple blind and 72patients who have enclusion criteria will divide two grops (intervention and placebo) by Block random sampling ,by factorial manner.
Settings and conduct
The target population includes all women with sexual dysfunction referred to public health clinics affiliated to Arak University of Medical Sciences.
In this study, 72 patients who have enclusion criteria will divide two grops (intervention and placebo) by Block random sampling.patients with severe depression, they will be excluded from the study by completing the Persian form of Beck Depression Inventory at the beginning of the study. Afterthat, interviews with patients and after completing the FSFI questionnaire, they randomly receive the drug / placebo.The drug is given at 10 cc in the morning and 10 cc in the nighting and the placebo is given in the same way for 4 weeks.For placebo, Stevia syrup is used. After regular use of the medication, the sexual function status of patients is again determined by the aforementioned questionnaire.The study is three-blind, and the patient, researcher and information analyst are not aware of the use of drugs or placebo .
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
-Sexual dysfunction in 6 independent areas,Age range 18 to 40 years,Married , sexually active:
Non-inclusion criteria: Severe depression in the patient, pregnancy, history of skin sensitivity to herbs in the family of Chattan, use of a drug affecting desire or sexual function , consuming energy drinks and consuming Drugs,..
Intervention groups
Parsynip syrup is given at 10 cc in the morning and 10 cc in the nighting and the placebo is given in the same way for 4 weeks.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20161004030131N2
Registration date:2019-04-28, 1398/02/08
Registration timing:prospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3524
Email address
f.shabani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-14, 1398/02/24
Expected recruitment end date
2020-01-14, 1398/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the Effect of Iranian Carrot Syrup (Parsnip) on Female Sexual Dysfunction: A Triple Blind Clinical Trial
Public title
Effect of Iranian Carrot Syrup (Parsnip) on Female Sexual Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sexual dysfunction in 6 independent areas ( desire, mental stimulation, lubrication, orgasm, satisfaction and pain)
Age range 18 to 40 years
Married
Sexually active
Exclusion criteria:
Severe depression in the patient
Pregnancy
History of skin sensitivity to herbs in the family of Chattan
Use of a drug affecting desire or sexual function such as serotonergic drugs (including citalopram fluoxetine, etc.)
Consuming energy drinks and consuming Drugs
Consuming blood diluent such as aspirin, warfarin, heparin or low molecular weight heparins
Chronic diseases such as diabetes, hormonal disorders such as thyroid, prolactin
Family problems and marital conflicts
Rape history
Wife's sexual problem
Consumption Anti hypertensive drugs
Menopause
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
By Block random sampling divide two grops intervention and placebo
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is three-blind, and the patient, researcher and information analyst are not aware of the use of drugs or placebo .
Placebo
Used
Assignment
Factorial
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Iran, Arak,sardasht, Basij Square, Arak University of Medical Sciences, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.ARAKMU.REC.1397.193
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52/9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Overall sexual performance score for women with sexual dysfunction
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Female Sexual Function Index questionnaire
2
Description
Average score for each sexual function areas ( desire, mental stimulation, lubrication, orgasm, satisfaction and pain) in women with sexual dysfunction
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Female Sexual Function Index questionnaire
3
Description
Depression
Timepoint
Before intervention
Method of measurement
Beck Depression Inventory questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Iranian Carrot Syrup (Parsnip) is a combination of 7 Iranian Pastinaca sativa L,Pimpinella anisum , honey, Elettaria cardamomum, Crocus sativus(saffron), Dianthus Caryophyllus (cloves )and Valeriana officinalis and Is prescribed 10 cc in the morning and 10 cc in the nighting for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: For placebo, stevia syrup is prescribed at 10 cc in the morning and 10 cc in the nighting for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Governmental Clinics of Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shabani
Street address
Arak University of Medicnces., Sardasht., Basij squal Scieare., Arak., Iran
City
Arak
Province
Markazi
Postal code
3819663345
Phone
+98 86 3417 3502
Fax
+98 86 3417 3524
Email
fatemeshabani46897@yahoo.com
Web page address
http://www.arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Arak University of Medical Sciences, Sardasht, Basij square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Fax
+98 86 3417 3524
Email
mmatinam81@yahoo.com
Web page address
http://www.arakmu.ac.ir
Grant name
-------
Grant code / Reference number
------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shabani
Position
M.S.C.in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Arak University of Medical Sciences, Sardasht, Basij square, . Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3502
Fax
+98 86 3417 3524
Email
f.shabani@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nejatbakhsh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine Faculty, . Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21886990837
Email
nejatbakhsh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shabani
Position
M.S.C.in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Arak University of Medical Sciences., Sardasht Ave., Basij square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 864173502
Email
fatemeshabani46897@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
Main outcome information
When the data will become available and for how long
Start the access period after published the results
To whom data/document is available
Academic and Scientific and industrial Institutions
Under which criteria data/document could be used
Original outcome information used in other research