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IRCT20260520069465N1 IRCT 2026-06-01 Ahvaz University of Medical Sciences Effect of Glutathione on patients with Multiple Sclerosis. Evaluation of the Effects of Glutathione on Cognitive and Motor Functions and Clinical Progression Indicators in Patients with Multiple Sclerosis. 2026-08-27 anticipated 60 Recruiting https://irct.ir/trial/90467 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Block randomization, Blinding description: 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.". 3 Multiple Sclerosis. Intervention Group: Thirty patients with relapsing-remitting multiple sclerosis will receive oral glutathione 500 mg once daily for 12 weeks in addition to their routine treatment.Control Group: Thirty patients with relapsing-remitting multiple sclerosis will receive a placebo identical in appearance and packaging to glutathione once daily for 12 weeks in addition to their routine treatment.. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: Qualified researchers upon reasonable request and approval by the principal investigator Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Esmat Ramezanirad
Neurology Ward.Gogestan Hospital.Golestan Ave
Ahvaz Iran (Islamic Republic of) 6135733117 +98 61 3320 4501 golestan_hospital@ajums.ac.ir Ahvaz University of Medical Sciences scientific Esmat Ramezanirad
Neurology Ward.Gplestan Hospital.Golestan.Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733117 009861332045016 ramazanirad-e@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Multiple Sclerosis Provision of written informed consent by the patient for participation in the study 18 years 50 years Both Patients with severe cognitive impairment or psychosis. Acute or chronic infection or inflammation during the two weeks prior to study enrollment. History of head trauma within the previous two weeks. History of hospitalization within the previous two weeks. History of a multiple sclerosis relapse within the previous two weeks. Pregnancy Breast feeding Treatment - Drugs Intervention Group: Thirty patients with relapsing-remitting multiple sclerosis will receive oral glutathione 500 mg once daily for 12 weeks in addition to their routine treatment.Control Group: Thirty patients with relapsing-remitting multiple sclerosis will receive a placebo identical in appearance and packaging to glutathione once daily for 12 weeks in addition to their routine treatment. Change in Expanded Disability Status Scale (EDSS) score. Timepoint: At the baseline and at the end of study(after 12 weeks of study). Method of measurement: Disease disability progression will be assessed using the Expanded Disability Status Scale (EDSS). EDSS scores will be recorded at baseline and after 12 weeks of treatment by a neurologist, and changes will be compared between the two groups. Change in Fatigue Scale score. Timepoint: from baseline to the end of the 12-week treatment period. Method of measurement: Fatigue severity will be measured using the Fatigue Scale questionnaire. 2. Change in completion time of the Six Spot Step Test (SSST). Timepoint: from baseline to the end of the 12-week treatment period. Method of measurement: Lower extremity motor function will be assessed by recording the completion time of the Six Spot Step Test (SSST). Change in completion time of the Nine-Hole Peg Test (9-HPT) as a measure of upper extremity motor function. Timepoint: from baseline to the end of the 12-week treatment period. Method of measurement: Upper extremity motor function will be assessed by recording the completion time of the Nine-Hole Peg Test (9-HPT). Change in completion time of the Trail Making Test (TMT) as a measure of cognitive function. Timepoint: from baseline to the end of the 12-week treatment period. Method of measurement: Cognitive function will be assessed by recording the completion time of the Trail Making Test (TMT). Vice Chancellor for Research and Technology.Ahvaz Jundishapur University of Medical Sciences Approved 2026-02-23 Ethics committee of Ahvaz University of Medical Sciences Neurology Ward, Golestan Hospital,Golestan Blv.,Ahvazd Ahvaz Khouzestan Iran (Islamic Republic of)