]>
IRCT20251006067522N1 IRCT 2025-10-29 Qazvin University of Medical Sciences Effect of Melatonin on Memory in Multiple Sclerosis Patients Investigating the Effect of Melatonin on Memory in Multiple Sclerosis Patients: A Clinical Trial 2025-11-22 anticipated 50 Complete https://irct.ir/trial/86667 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 Multiple Sclerosis (Relapsing-Remitting Type). Intervention group: Melatonin administration: Patients receive 5 mg of melatonin daily, one hour before sleep, for 12 weeks.. Yes - There is a plan to make this available What will be shared: The data within the document includes aggregated study design information, inclusion/exclusion criteria, primary outcome variables, and initial IRCT registration details. Due to ethical considerations and privacy concerns, individual participant data (e.g., memory test results or personal details) cannot be fully shared; only de-identified data related to primary outcomes (e.g., Colour Wheel Test results) can be provided after receiving approval from the Qazvin University of Medical Sciences Ethics Committee and complying with institutional policies. The document also contains a CRS system link and preliminary IRCT registration information, indicating the clinical trial registration process. When: The access period for the data/document will begin 6 months after the publication of the study results, anticipated to be around mid-April 2026, and will remain available for 5 years thereafter. To whom: Access to the data or document is allowed for researchers affiliated with accredited academic or scientific institutions. These individuals must submit a formal request with identification documents and a description of their research aims, while following ethical guidelines and privacy laws. Conditions: The data or document may only be used for academic research purposes, including statistical analysis, replication studies, and scientific investigations related to the effect of melatonin on memory in patients with multiple sclerosis. Usage conditions include obtaining ethical approval from the Qazvin University of Medical Sciences Ethics Committee, signing a confidentiality and data use agreement, and ensuring that no participant can be re-identified. Applicants must submit a written request outlining their research objectives, analysis. Where to obtain: Applicants seeking access to the data or documents should first contact the Principal Investigator, Dr. Hossein Mozhdehipanah, via email (hmozhdehipanah@qums.ac.ir) or phone (09123040087). If there is no response, they are advised to reach out to the Research Deputy of Qazvin University of Medical Sciences through the website or by phone (028-33336001). Additionally, the IRCT support system can be contacted via email (irct@iums.ac.ir) if necessary. Priority is given to official email communication, and a written request with the necessary documentation must be submitted. How to obtain: The process for requesting data/documents is as follows: The applicant must submit a written request, including research objectives, analysis methods, and identification documents, to the Principal Investigator’s email (hmozhdehipanah@qums.ac.ir). The request will be reviewed by the Principal Investigator and referred to the Qazvin University of Medical Sciences Ethics Committee for ethical approval (approximate duration: 1-2 weeks). Upon ethical approval, the applicant must sign a confidentiality and data use agreement. After completing the agreement, the de-identified data will be provided securely (e.g., encrypted file) via email or the university’s secure platform. In case of issues, the applicant may contact the Research Deputy or IRCT support (irct@iums.ac.ir). The entire process typically takes 2-3 weeks, contingent on complete documentation and compliance with regulations. Comments:
public Kavosh Ansari Dezfoli
Building No. 12, Bu-Ali Street, Qazvin, Qazvin Province, 34197, Iran
Qazvin Iran (Islamic Republic of) 1531534199 +98 937 538 6185 k.ansaridezfoli@qums.ac.ir Qazvin University of Medical Sciences scientific Kavosh Ansari Dezfoli
Building No. 12, Bu-Ali Street, Qazvin, Qazvin Province, 34197, Iran
Qazvin Iran (Islamic Republic of) 1531534199 +98 937 538 6185 k.ansaridezfoli@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of MS based on McDonald criteria and confirmed by a specialist physician. Age between 18 and 60 years. Diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS). Suffering from short-term memory disorders detectable by pre-test assessment. 18 years 60 years Both Age less than 18 years or more than 60 years. Lack of written patient consent to participate in the study. Diagnosis of MS types other than Relapsing-Remitting MS (RRMS). Use of other medications that may affect memory or sleep. History of allergy or sensitivity to melatonin. Presence of other chronic conditions such as uncontrolled diabetes or kidney failure. Alcohol or drug use in the past 6 months. Pregnancy or breastfeeding G35 Multiple sclerosis Treatment - Drugs Intervention group: Melatonin administration: Patients receive 5 mg of melatonin daily, one hour before sleep, for 12 weeks. Short-term visual memory Description: Short-term visual memory is measured using the Colour Wheel Test. This variable refers to the patients' ability to recall and reproduce colours within a short time frame (a few seconds to a few minutes), with evaluation criteria including error rate, response time, and confidence in colour selection. Timepoint: Measurement of outcome variables will be conducted at two time points: initially, before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Short-term visual memory: Measured using the Colour Wheel Test, which involves selecting colours on a simulated display screen, with criteria including error rate, response time, and confidence in selection. Potential side effects of melatonin are recorded through patient reports and clinical examinations by healthcare staff. This variable includes any physical or psychological symptoms reported by patients during the intervention period. Timepoint: Measurement of outcome variables will be conducted at two time points: initially, before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Recorded through patient verbal reports and clinical examinations by healthcare staff. Changes in quality of life are assessed using standard questionnaires (such as health-related quality of life questionnaires). This variable reflects improvements or reductions in general well-being, daily functioning, and patient satisfaction with life. Timepoint: Measurement of outcome variables will be conducted at two time points: initially before the intervention (pre-test) and then 12 weeks after the start of melatonin use (post-test). Method of measurement: Changes in quality of life: Assessed using standard health-related quality of life questionnaires (e.g., SF-36). Qazvin University of Medical Sciences Approved 2025-08-26 Qazvin University of Medical Sciences Building No. 12, Bu-Ali Street, Qazvin, Qazvin Province, 34197, Iran Qazvin Qazvin Iran (Islamic Republic of)