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

Determination of the Effectiveness of an Oral Product Containing Cress Seeds on Improving Sexual Dysfunction in Female Patients with Multiple Sclerosis (MS) as a Clinical Trial Study.

This is a phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial involving 68 patients. Randomization will be performed using the 'Random Allocation 2' statistical software.

One gram capsule is prepared from Cress seed powder. Standardization and physicochemical control of the product is done in the Faculty of Pharmacy. Subsequently, a double-blind randomized clinical trial will be performed at the MS clinic of Bu-Ali Sina Sari Educational Center involving 34 patients over the age of 18 in each group called the intervention group (capsules containing Cress seed) and control (capsules containing starch); Patients meeting the MCDonald 2017 criteria with an EDSS score of less than 5.5 and an MSISQ-19 score higher than 27 after MS Fellowship and obtaining consent are entered into the study. By observing the apparent similarity of the drug products, the patient receiving the drug and the researcher evaluating the study variables and the prescribing neurologist are not aware of the type of drug received.

Inclusion Criteria: Patients with multiple sclerosis aged over 18 years, presenting with an EDSS score of less than 5.5 and sexual dysfunction indicated by an MSISQ-19 score greater than 27. Exclusion Criteria: Patients with severe depression, hypothyroidism, diabetes, history of seizures

Patients will be block‑randomized to receive either oral capsules containing powdered cress seeds or a placebo for a period of 12 weeks. The study medication will be administered as 1‑gram capsules taken twice daily.

Patients quality of life, sexual function status

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.

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.