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The effect of melatonin on the severity of sleep symptoms in patients with restless leg syndrome

Investigating the effect of melatonin on the severity of signs and sleep quality of patients with restless leg syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191104045328N26
Enrollment
60
Registered
2024-08-27
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless leg syndrome. Restless legs syndrome

Interventions

Intervention 1: Intervention group: In the melatonin group, one 3 mg melatonin tablet produced by Razak company will be prescribed daily for 2 months for each patient. Intervention 2: Control group: I

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients with restless leg syndrome who visited Amir al-Momenin Arak Hospital. Aged 18-65 years old A history of illness for at least three months Consent to participate in the study

Exclusion criteria

Exclusion criteria: The presence of an underlying neurological disorder Having a history of spinal cord injury disorders or cerebral sensory and motor disorders The presence of chronic kidney and liver disease through the tests of patients in the file, which are evaluated in terms of routine liver and kidney tests at the beginning of the visit. pregnancy Taking drugs that interfere with melatonin, such as anti-epileptic drugs

Design outcomes

Primary

MeasureTime frame
Severity of the disease. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: International Restless Legs Syndrome questionnaire.;Sleep quality score. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Pittsburgh Sleep Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Rezaei Ashtiani

Arak University of Medical Sciences

dr.ashtiani@arakmu.ac.ir+98 86 3417 3601

Outcome results

None listed

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