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Investigating the effect of crocin on patients with multiple sclerosis

Investigating the effect of crocin on quality life, anxiety and depression in patients with multiple sclerosis in a placebo-controlled randomized double blind clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221109056447N1
Enrollment
40
Registered
2023-11-29
Start date
2023-11-22
Completion date
Unknown
Last updated
2024-01-22

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. According to the diagnosis of a specialist doctor, for the treatment of anxiety and depression in these pa

Sponsors

Oroumia 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. Patients with MS aged 18 to 50 (relapsing-remitting MS or RRMS). No relapse attacks one month before t the study. Obtaining 0 to 5.5 points based on the disability scale. Patients who take first and second line drugs in oral and injectable form (dimethyl fumarate, Resigen, Betaferon, Triflunomide, Fingolimido Sinomer). According to the specialist doctor, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs for the treatment of anxiety and depression in these patients. Expression of willingness to participate in the study.

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. 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

Design outcomes

Primary

MeasureTime frame
The effect of crocin on the anxiety intensity. Timepoint: Measuring anxiety intensity at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Beck's anxiety questionnaire.;The effect of crocin on the depression Intensity. Timepoint: Measuring depression severity at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Beck's depression questionnaire.;Effect of crocin on quality of life. Timepoint: Measuring quality of life at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Questionnaire of quality of life of MS patients MsQoL-54 (Multiple Sclerosis Quality of Life-54).

Secondary

MeasureTime frame
Investigating the effect of crocin on periodic pain assessments. Timepoint: Examining periodic pain assessments at the beginning of the study (before the study) and two months after the intervention. Method of measurement: Examining periodic pain assessments from the McGill Pain Questionnaire (MPQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Samaneh Sepahi

Oroumia University of Medical Sciences

sepahi.s@umsu.ac.ir009832234897

Outcome results

None listed

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