Evaluation of the effectiveness of carrot seeds in women with Hypoactive sexual desire disorder(HSDD) during reproductive age : double- bind clinical trial
Effectiveness of carrot seeds in women with reduced libido during fertility period
Design
Two arm parallel group trial with double blinded randomization
Settings and conduct
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 of the study . Subsequently they fill FSFI (Female Sexual Function Index) questionnaire . They fill the same questionnaire after being on treatment for 6 weeks and 12 weeks. In this study, the researchers and individuals involved in the design and individual data analysis are blind.Faculty of Iranian Medicine, Iran University Of Medical Science and sexology department of Imam Khomeini hospital, are location of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:Reduced libido according to DSM-4; 18-45 years old; Normal Pap smear; Normal pelvic exam.
Exclusion criteria: Presence of serious medical or psychological diseases; Menopause; Divorce intent; Pregnancy; Lactation;
Intervention groups
Intervention group: 30 people take 500mg of carrot seeds three times daily.Control group: 30 people take 500mg of placebo three times daily
Main outcome variables
This study evaluate the effect of our herbal remedy Daucus carrota, on desire; arousal; satisfaction; orgasm; dysparonia; lubrication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180224038847N1
Registration date:2018-05-01, 1397/02/11
Registration timing:prospective
Last update:2018-05-01, 1397/02/11
Update count:0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Rosita Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3280 8025
Email address
rositabahrami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of carrot seeds in women with Hypoactive sexual desire disorder(HSDD) during reproductive age : double- bind clinical trial
Public title
Effectiveness of carrot seeds in female with decreased libido
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Loss or decrease in sexual desire according to DSM-4 criteria
18-45 years old
Having a spouse who spends at least half a month with his family
Normal pelvic exam
Normal Pap smear
At least 6 month duration of marriage
Exclusion criteria:
Serious medical or chronic disease
Sever depression, suicidal, psychotic disease
Menopause
Divorce intent
Pregnancy
Lactation
Skin allergy to Umbelliferac
Familial problem
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a quadrilateral random blocks manner
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researchers and individuals involved in the design and individual data analysis are blind. After randomization and splitting into two groups, a group of products from carrot eggs was given as 500 mg capsules three times a day, and simultaneously the control group received placebo, which was received as a completely similar capsule containing placebo. The prescriptive form is similar in the two groups and is administered in a blind, randomized manner.That is, taking the drug based on the sequences of the random blocks determined by the statistician and the associate pharmacist on the envelopes in letters, in such a way that the patient, the pharmacist and the interviewer are not aware of the contents of the envelope. The letter insert on the envelope is recorded on the questionnaire sheet
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.IUMS.REC.1396.9321309007
Health conditions studied
1
Description of health condition studied
Lack or loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Libido
Timepoint
At beginning of the trial, 6 weeks and 12weeks after starting drug or placebo
Method of measurement
FSFI questionaire
Secondary outcomes
1
Description
Arousal
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
2
Description
Dysparonia
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
3
Description
Satisfaction
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
4
Description
Orgasm
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
5
Description
Lubrication
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
6
Description
Total sexual function
Timepoint
At beginning of the trial, 6 weeks and 12 weeks after starting drug or placebo
Method of measurement
FSFI questonnaire
7
Description
Frequency of probable adverse effect of the drug
Timepoint
Weekly after starting the drug
Method of measurement
Phone report by patient
8
Description
Depression
Timepoint
At beginning and after finishing of the intervention
Method of measurement
Beck Deppression Inventory test(BDI)
Intervention groups
1
Description
Intervention group: Capsule contains 500mg carrot seeds three times daily
Category
Treatment - Drugs
2
Description
Control group: Capsule contains 500mg of the placebo three times daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Iranian Medicine, Iran University Of Medical Science
Full name of responsible person
Rosita Bahrami
Street address
Faculty of Iranian Medicine,Behesht Street,Hassan Abad Square,Tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9723
Email
rositabahrami@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Rosita Bahrami
Street address
Qarib street, Azadi street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2756
Email
rositabahrami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakoti
Street address
Iran University of Medical Sciences,Besides Milad Tower,Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
rositabahrami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Rosita Bahrami
Position
Student of PHD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine,Behesht St,Tehran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5515 2191
Email
rositabahrami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rosita Bahrami
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
N.358, Shomali Blvd, Banafshe Town
City
Karaj
Province
Alborz
Postal code
3174878444
Phone
+98 26 3280 8025
Fax
Email
rositabahrami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rosita Bahrami
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
N.358, Shomali Blvd, Banafshe Town
City
Karaj
Province
Alborz
Postal code
3174878444
Phone
+98 26 3280 8025
Fax
Email
rositabahrami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available