Protocol summary
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Study aim
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Investigating the effect of carrot (Daucus carota) seed capsules on the sexual desire of female patients with multiple sclerosis
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Design
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Phase 2 randomized double-blinded placebo parallel clinical trial on 40 patients
Randomization using Randomaization.com
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Settings and conduct
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Ghaeem hospital MS clinic
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-03-14, 1401/12/23
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2023-04-21, 1402/02/01
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Expected recruitment end date
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2028-04-20, 1407/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of carrot (Daucus carota) seed capsules on the sexual desire of female patients with multiple sclerosis
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Public title
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Investigating the effect of carrot seed capsules on the sexual desire of female patients with multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-06, 1401/06/15
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1401.429
Health conditions studied
1
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Description of health condition studied
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Women suffering from multiple sclerosis complaining of lack or absence of sexual desire
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ICD-10 code
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F52.0
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ICD-10 code description
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Hypoactive sexual desire disorder
Primary outcomes
1
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Description
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Overall score of the FSFI questionnaire
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Timepoint
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At the beginning of the study and then every 4 weeks until week 12
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Method of measurement
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FSFI Questionnaire
Secondary outcomes
1
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Description
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Fatigue rate
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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MFIS fatigue assessment questionnaire
2
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Description
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The level of anxiety and depression
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Spielberger anxiety questionnaire
3
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Description
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LH levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
4
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Description
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FSH levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
5
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Description
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Prolactin levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
6
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Description
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Testosterone levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
7
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Description
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CBC diff levels
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Timepoint
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At the beginning of the study and after 6 and 12 weeks of treatment
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Method of measurement
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Laboratory kit
8
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Description
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Interleukin-6 levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
9
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Description
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TNF-a levels
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Timepoint
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At the beginning of the study and after 12 weeks of treatment
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Method of measurement
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Laboratory kit
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available