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

Clinical trial comparing the efficacy and safety of N-acetylcysteine and amantadine on fatigue and disability and quality of life of patients with MS

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201216049736N1

Enrollment

112

Registered

2020-12-31

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-01-05

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: The first group will be treated with N-acetylcysteine tablets (Exir Company) at a dose of 600 mg every 12 hours. Intervention 2: Intervention group: The second grou

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

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

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 ....

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Ghasemi

Ahvaz University of Medical Sciences

fatemeh.ghasemi@gmail.com+98 61 3374 3012

Outcome results

None listed

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