Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2025-04-21, 1404/02/01
2028-04-20, 1407/02/01
20252028-04-2120 00:00:00
empty
Unfortunately, due to the specific family circumstances of some patients, including the lack of consent of the patients' spouses, as well as changes in the project's clinical specialist colleagues due to immigration, the patient recruitment was not completed on time, and the researchers were forced to extend the sampling period for this project.
Unfortunately, due to the specific family circumstances of some patients, including the lack of consent of the patients' spouses, as well as changes in the project's clinical specialist colleagues due to immigration, the patient recruitment was not completed on time, and the researchers were forced to extend the sampling period for this project.
empty
متاسفانه با توجه به شرایط خاص خانوادگی برخی بیماران من جمله عدم موافقت همسر بیماران و همچنین تغییر در همکاران متخصص بالینی طرح بعلت مهاجرت، بیمارگیری در موعد مقرر به اتمام نرسید و محققین مجبور شدند تا زمان نمونه گیری این طرح را تمدید نمایند.
متاسفانه با توجه به شرایط خاص خانوادگی برخی بیماران من جمله عدم موافقت همسر بیماران و همچنین تغییر در همکاران متخصص بالینی طرح بعلت مهاجرت، بیمارگیری در موعد مقرر به اتمام نرسید و محققین مجبور شدند تا زمان نمونه گیری این طرح را تمدید نمایند.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Majid Ghayour-Mobarhan
Full name of responsible person - Persian: دکتر مجید غیور مبرهن
Street address - English: Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: ramresearch@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohsen Tafaghodi
Full name of responsible person - Persian: دکتر محسن تفقدی
Street address - English: Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: ramresearch@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Majid Ghayour-MobarhanMohsen Tafaghodi Full name of responsible person - Persian: دکتر مجید غیور مبرهنمحسن تفقدی Street address - English: Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 2081 Fax: Email: ramresearch@mums.ac.ir Web page address:
Protocol summary
Study aim
Investigating the effect of carrot (Daucus carota) seed capsules on the sexual desire of female patients with multiple sclerosis
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 40 patients
Randomization using Randomaization.com
Settings and conduct
Ghaeem hospital MS clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women; suffering from multiple sclerosis; Age between 18-45 years; complaining of lack or absence of sexual desire; more than 6 months have passed since their marriage; Normal pelvic examination findings; Have a normal pap smear in the past 3 years; Have access to having sex with a partner monthly for at least 15 days.
Exclusion criteria: Pregnancy or breastfeeding; Menopause; Disability or serious medical problem that requires constant care and treatment; Suffering from major depressive disorder and other psychiatric disorders; Husband's sexual problems; Divorce.
Intervention groups
Intervention group: Women suffering from multiple sclerosis who use 500 mg capsules containing carrot seed powder 3 times a day for 12 weeks.
Placebo group: Women suffering from multiple sclerosis who use placebo capsules similar to carrot seed capsules three times a day for 12 weeks.
Main outcome variables
The overall score of the FSFI questionnaire, which is evaluated at the beginning of the study and every 4 weeks until the 12th week.
General information
Reason for update
Unfortunately, due to the specific family circumstances of some patients, including the lack of consent of the patients' spouses, as well as changes in the project's clinical specialist colleagues due to immigration, the patient recruitment was not completed on time, and the researchers were forced to extend the sampling period for this project.
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N14
Registration date:2023-03-14, 1401/12/23
Registration timing:prospective
Last update:2025-12-16, 1404/09/25
Update count:1
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2028-04-20, 1407/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of carrot (Daucus carota) seed capsules on the sexual desire of female patients with multiple sclerosis
Public title
Investigating the effect of carrot seed capsules on the sexual desire of female patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with multiple sclerosis
Age between 18-45
With complaints of lack or absence of sexual desire
More than 6 months have passed since their marriage
Normal pelvic examination findings
Have a normal pap smear in the last 3 years
Have access to having sex with a partner monthly for at least 15 days
Exclusion criteria:
Pregnancy or breastfeeding
Menopause
Any disability or serious medical problem that requires constant care and treatment
Suffering from major depressive disorder and other psychiatric disorders
Husband's sexual problems
Divorce
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 10 blocks according to the sample size of 40. Then random numbers between 1 and 10 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
School of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.429
Health conditions studied
1
Description of health condition studied
Women suffering from multiple sclerosis complaining of lack or absence of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Overall score of the FSFI questionnaire
Timepoint
At the beginning of the study and then every 4 weeks until week 12
Method of measurement
FSFI Questionnaire
Secondary outcomes
1
Description
Fatigue rate
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
MFIS fatigue assessment questionnaire
2
Description
The level of anxiety and depression
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Spielberger anxiety questionnaire
3
Description
LH levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
4
Description
FSH levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
5
Description
Prolactin levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
6
Description
Testosterone levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
7
Description
CBC diff levels
Timepoint
At the beginning of the study and after 6 and 12 weeks of treatment
Method of measurement
Laboratory kit
8
Description
Interleukin-6 levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
9
Description
TNF-a levels
Timepoint
At the beginning of the study and after 12 weeks of treatment
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg capsules containing carrot seed powder 3 times a day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Women suffering from multiple sclerosis with complaints of lack or absence of sexual desire use 500 mg placebo capsules similar to carrot seed capsules 3 times a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital MS clinic- Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vahid Reza Askari
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2000
Email
askariv@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
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
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
Dr. Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
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