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Investigating the effect of crocin in multiple sclerosis patients

Investigating the effect of crocin on the severity of fatigue, pain and quality of life in patients with multiple sclerosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130418013058N17
Enrollment
40
Registered
2023-08-02
Start date
2023-10-12
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS or multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: who receive one 15 mg crocin tablet daily for two months. Intervention 2: Control group: Placebo recipients (placebo), who receive one placebo tablets daily for two

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of MS with neurologist visit, based on the McDonald diagnostic criteria, at least 6 months have passed since the diagnosis. Patients with relapsing-remitting MS or RRMS receiving first- and second-line MS disease therapy. No relapse attacks one month before of the study. Expression of willingness to participate in the study. 0 to 5 points based on expanded disability status scale. ?a fatigue intensity score equal to or higher than 4 according to the Fatigue severity scale Having a feeling of chronic pain in at least one of the body organs and a score higher than 4 based on Numerical rating scale. MS patients who take first and second line drugs (dimethyl fumarate, Resigen, Betaferon, Triflunomide, Fingolimido Cinomer).

Exclusion criteria

Exclusion criteria: Suffering from other diseases such as (chronic diseases, heart failure, glands, breathing, liver, kidney, skeletal-muscular) and mental diseases and severe depression. Addiction to alcohol, drugs and psychedelics History of allergy to saffron Pregnancy and breastfeeding The presence of severe infection and inflammation, varicose veins, active thrombosis, damage to organs such as fractures. Motor disability score higher than 6 Getting any other serious diseases such as heart, liver and kidney diseases during treatment Do heavy exercise daily Any use of anti-inflammatory and antioxidant drugs as a supplement or Amantadine as an anti-fatigue drug Unwillingness to participate in the study or continue the treatment process

Design outcomes

Primary

MeasureTime frame
Fatigue. Timepoint: Before and two months after the intervention. Method of measurement: MFIS fatigue assessment questionnaire.;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).

Secondary

MeasureTime frame
Sexual desire. 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

mohajeria@mums.ac.ir+98 51 3882 3251

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026