An effectiveness and safety comparison study of N-acetylcysteine and amantadine on fatigue and Disability and quality of life of multiple sclerotic patients

Phase 3

Recruiting

Conditions: Multiple sclerosis.
Multiple sclerosis

Registration Number: IRCT20201216049736N1

Lead Sponsor: Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 112

Inclusion Criteria

Patients with definitive diagnosis of MS aged 18 to 50 years
Be in the offensive phase (at least one month after the attack)
Disability rate according to EDSS criteria is between 1 to 5.5.
Fatigue is 4 or higher according to the FSS criteria.
If interferon is used to treat multiple sclerosis, at least 6 months have passed since the start of this drug.

Exclusion Criteria

History of corticosteroid use during the month before treatment
Taking supplements or drugs with antioxidant properties such as vitamins E and C, zinc, melatonin
Taking medications that cause fatigue and drowsiness (such as benzodiazepines, tricyclic antidepressants,sedatives, anticonvulsants)
Taking stimulant drugs, amantadine, dopaminergic drugs
Pregnancy and lactation
History of NAC allergy or any side effects
Existence of depression (according to Beck questionnaire)
Accompanying medical conditions that can cause fatigue, such as: sleep disorders, heart failure, anemia, hypothyroidism and ....

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Fatigue questionnaire according to Fatigue severity scale.

Secondary Outcome Measures

Name	Time	Method
Degree of disability. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Expanded Disability Status Scale.;Quality of Life. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Multiple Sclerosis Quality of Life-54 Questionnaire.