MS or Multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: During the two-month period, they will receive oral capsules containing a combination of 7.5 mg crocin and 150 mg curcumin twice daily (BID), totaling 15 mg crocin
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Definite diagnosis of multiple sclerosis confirmed by the neurologist, based on the McDonald criteria, with a minimum of 6 months since diagnosis and a disease duration of no more than 10 years. Patients with relapsing-remitting multiple sclerosis (RRMS) receiving first-line and second-line disease-modifying therapies. Absence of relapse one month prior to study enrollment. Willingness to participate in the study. Expanded Disability Status Scale (EDSS) score of 0 to 5. Fatigue Severity Scale (FSS) score equal to or greater than 4. Presence of chronic pain in at least one limb and a Numerical Rating Scale (NRS) pain intensity score greater than 4. Patients with multiple sclerosis receiving first-line and second-line disease-modifying therapies (dimethyl fumarate, reciGen, Betaferon, teriflunomide, fingolimod, glatiramer acetate). Absence of underlying comorbidities such as diabetes, cardiovascular diseases, and genetic disorders. Patient compliance: ability to participate in interviews and communicate feelings and experiences.
Exclusion criteria
Exclusion criteria: Presence of other underlying comorbidities (chronic diseases, cardiovascular, endocrine, respiratory, hepatic, renal, musculoskeletal disabilities), mental disorders, and severe depression. Addiction to alcohol, narcotics, and psychotropic substances. History of saffron or turmeric allergy. Pregnancy and lactation. Presence of severe infection and inflammation, varicose veins, active thrombosis, limb injuries such as fractures. Expanded Disability Status Scale (EDSS) score greater than 6. New onset of any other serious illness such as cardiac, hepatic, and renal diseases during treatment. Performance of strenuous daily exercise. Any use of anti-inflammatory and antioxidant drugs as supplements, or amantadine as an anti-fatigue medication. Unwillingness to participate in the study or continue the treatment process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: Before and two months after the intervention. Method of measurement: VAS or visual analog scale questionnaire.;Quality of life. Timepoint: Before and two months after the intervention. Method of measurement: Quality of Life Questionnaire Multiple Sclerosis Impact Scale (MSIS-29).;Fatigue. Timepoint: Before and two months after the intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) fatigue assessment questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual function. Timepoint: Before and two months after the intervention. Method of measurement: Men (International Index of Erectile Function ) and women's (Female Sexual Function Index ) sexual health questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. seyed Ahmad Mohajeri
Mashhad University of Medical Sciences
Outcome results
None listed