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Effect of nano formulation of saffron crocin in patients with multiple sclerosis

Effect of nano formulation of saffron crocin on depression symptoms and cognitive impairment in patients with multiple sclerosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120227009157N7
Enrollment
40
Registered
2018-02-16
Start date
2018-04-22
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: intervention group will receive two nano-crocin capsules which contain 0.27 mg of nano-crocin every day for 12 weeks. Intervention 2: Control group: placebo group w

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: • Willingness to participate in the study• Age range between 18 to 60 years old Diagnosis of relapse remission multiple sclerosis according to the McDonalds 2010 criteria and taking B-interferon as treatment Diagnosis of mild to moderate according to DSM V(Diagnostic and Statistical Manual of Mental Disorders, 5th edition) by a neurologist and Beck Depression Inventory (BDI-II) (score from 11 to 20) EDSS lower than 5.5

Exclusion criteria

Exclusion criteria: Pregnancy (or having a planned pregnancy) or Lactation Allergy or sensibility to the drugs at the beginning of their treatments History of allergy or sensibility to Saffron or its components Receiving IVIG during the last six months of treatment Increase of liver enzymes three times more than normal value Stop taking drugs for more than forth months

Design outcomes

Primary

MeasureTime frame
Minimal Assessment of Cognitive Function in MS (MACFIMS) total score. Timepoint: baseline. Method of measurement: after 12-week intervention.

Secondary

MeasureTime frame
Total score of beck's depression inventory. Timepoint: baseline. Method of measurement: after 12-week intervention.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Soodeh Razeghi Jahromi

Shahid Beheshti University of Medical Sciences

razeghi@sina.tums.ac.ir+98 21 22357

Outcome results

None listed

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