Evaluation of the Effects of Glutathione on Cognitive and Motor Functions and Clinical Progression Indicators in Patients with Multiple Sclerosis.

To evaluate the effect of glutathione on motor function, cognitive function, fatigue severity, and disease progression in patients with multiple sclerosis.

A randomized, double-blind, controlled clinical trial with 60 participants. Randomization was performed using the RAND function in Microsoft Excel. The study includes an intervention group and a control group.

Randomized, double-blind, placebo-controlled trial in 60 RRMS patients. Participants receive glutathione 500 mg or placebo for 12 weeks. EDSS, Fatigue Scale, SSST, 9-HPT, and TMT are assessed at baseline and study end. Patients and assessors are blinded

Inclusion Criteria: "Confirmed diagnosis of Multiple Sclerosis according to the 2023 McDonald criteria Age 18–50 years Expanded Disability Status Scale (EDSS) score ≤ 6.5 Provision of written informed consent for participation in the study Exclusion criteria: "History of infection or hospitalization within the previous two weeks "History of a multiple sclerosis relapse within the previous two weeks "Severe cognitive impairment or psychosis

Sixty patients with relapsing-remitting multiple sclerosis will be randomly assigned to two groups. The intervention group (n=30) will receive oral glutathione 500 mg daily for 12 weeks in addition to routine treatment, while the control group (n=30) will receive a matching placebo for 12 weeks in addition to routine treatment.

Change in EDSS score; Change in Fatigue Scale score; Change in Six Spot Step Test (SSST) performance; Change in Nine-Hole Peg Test (9-HPT) performance; Change in Trail Making Test (TMT) performance

Block randomization

This study will be conducted as a double-blind clinical trial. Neither the participants nor the investigators/outcome assessors will be aware of the treatment allocation. Glutathione and placebo will be prepared in identical formulations, packaging, appearance, and labeling. Treatment codes will be kept confidential by an independent third party and will not be disclosed until completion of data collection and analysis, except in cases of medical emergency."

Title: Research Data on the Effects of Glutathione on Cognitive Function, Motor Function, and Clinical Progression in Patients with Multiple Sclerosis Details: De-identified participant data, including EDSS scores, Fatigue Scale scores, and results of the Trail Making Test (TMT), Nine-Hole Peg Test (9-HPT), and Six Spot Step Test (SSST) at baseline and after 12 weeks of treatment, will be collected. The data may be made available after publication of the study results in accordance with research ethics regulations and while maintaining participant confidentiality.

De-identified study data will be available after publication of the study results without a time limit, subject to research ethics regulations and participant confidentiality.

Qualified researchers upon reasonable request and approval by the principal investigator

The de-identified data may be used for scientific research, secondary analyses, systematic reviews, and meta-analyses related to multiple sclerosis. Access to the data will be granted upon reasonable request, approval by the principal investigator, and compliance with research ethics regulations and participant confidentiality requirements.

Requests for access to study data and related documents should be directed to the principal investigator Department of Neurology Ahvaz Jundishapur University of Medical Sciences Ahvaz Iran.

Requests for access to study data and related documents should be submitted in writing to the principal investigator. Requests will be reviewed by the research team, and access may be granted upon approval while ensuring participant confidentiality and data protection.