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IRCT20160913029802N5 IRCT 2026-04-22 Mazandaran University of Medical Sciences Investigation of the Effect of Oral Consumption of Cress Seed on Sexual Dysfunction in Female Patients with Multiple Sclerosis Investigation of the effects of oral consumption of Lepidium sativum L. seed on sexual dysfunction in female patients with multiple sclerosis: A randomized double-blind placebo-control clinical trial 2026-06-05 anticipated 68 Recruiting https://irct.ir/trial/89197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For the allocation of participants into two groups, a randomized block method will be used. For this purpose, participants will be randomly assigned numbers from 1 to 68. The randomization unit will be individual, using blocks of four. The group assignment for each participant will be determined using the statistical software Random Allocation 2. To generate the random sequence, codes A and B will be produced by the software. The codes will then be placed in sealed envelopes, with each envelope labeled with the participant’s number. The research team will open the envelopes, and if the code is A, the participant will be assigned to the drug group; if the code is B, the participant will be assigned to the placebo group, Blinding description: The visual similarity between the drug-containing capsules and the placebo will be ensured, and both will be placed in identical, coded drug packages according to the randomization table. Each code will correspond to a specific participant. Neither the patients receiving the medication, the pharmacy student assessing the study variables, nor the prescribing neurologist will be aware of the type of drug administered. In the event of any serious adverse effect following the prescribed product, the participant’s code will be unblinded. It should be noted that the principal investigator of the study is aware of the randomization codes. 2-3 Condition 1: Multiple Sclerosis. Condition 2: Sexual dysfunction associated with multiple sclerosis. Intervention 1: Intervention group: Participants receiving the oral product containing powdered cress seeds prepared in the Pharmacognosy and Pharmaceutics laboratories of the Faculty of Pharmacy, Sari. The product will be administered twice daily at a dose of 1 gram per dose. The duration of treatment will be 12 weeks. Intervention 2: Control group: The control group will receive capsules containing starch, prepared in the Pharmaceutics Laboratory of the Faculty of Pharmacy, Sari. The product will be administered twice daily at a dose of 1 gram per dose. The duration of treatment will be 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to ethical considerations and the confidentiality of participant information, there is no plan to share individual participant data.
public Monireh Ghazaeian
Faculty of Pharmacy, Mazandaran University of Medical Sciences, , Farahabad Road
sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3082 ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Somayeh Shahani
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Farahabad Road
sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3082 so.shahani@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 years and older diagnosed with multiple sclerosis, according to the 2015 McDonald criteria, with an EDSS score of less than 5.5. Sexually active in the past six months and experiencing sexual problems, with an MSISQ-19 score above 27. 18 years no limit Female Severe depression assessed using the HADS questionnaire (score of 11 or higher) Hypothyroidism Untreated anemia History of seizures Diabetes History of bulimia nervosa or anorexia nervosa Presence of a known severe psychiatric disorder Pregnancy or breastfeeding Exposure to major crises, such as the death of close relatives, in the past six months Genitourinary environmental problems G35 F66 Multiple sclerosis Other sexual disorders Lifestyle Placebo Intervention group: Participants receiving the oral product containing powdered cress seeds prepared in the Pharmacognosy and Pharmaceutics laboratories of the Faculty of Pharmacy, Sari. The product will be administered twice daily at a dose of 1 gram per dose. The duration of treatment will be 12 weeks. Control group: The control group will receive capsules containing starch, prepared in the Pharmaceutics Laboratory of the Faculty of Pharmacy, Sari. The product will be administered twice daily at a dose of 1 gram per dose. The duration of treatment will be 12 weeks. Sexual dysfunction. Timepoint: At baseline, and at 6 and 12 weeks after the start of treatment. Method of measurement: The 19-item Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19). Multiple Sclerosis Quality Of Life. Timepoint: At baseline, and at 6 and 12 weeks after initiation of treatment. Method of measurement: Multiple Sclerosis Quality Of Life 54(MSQOL-54) score. Mazandaran University of Medical Sciences Approved 2026-02-21 Ethics committee of Mazandaran University of Medical Sciences Vice Chancellor for Research and Technology, Moallem Square Sari Mazandaran Iran (Islamic Republic of)