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Comparative study of therapeutic effects of Gabapentin versus Levodopa-c on Restless legs syndrome in hemodialysis patientes

Comparative study of therapeutic effects of Gabapentin versus Levodopa-c on Restless legs syndrome in hemodialysis patientes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112078323N1
Enrollment
Unknown
Registered
2012-01-15
Start date
2011-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

RLS: Restless Legs syndrome.. Other specified extrapyramidal and movement disorders

Interventions

Intervention 1: capsules of gabapentin 200 mg after evry hemodialysis for 4wks 2hours befor sleep. Intervention 2: tablet levodopa -c 110mg nightly 2 hours befor sleep for 4 wks.
Treatment - Drugs
capsules of gabapentin 200 mg after evry hemodialysis for 4wks 2hours befor sleep
tablet levodopa -c 110mg nightly 2 hours befor sleep for 4 wks

Sponsors

Sponsor name 1 Vice-chancellor of Research and Technology of Kermanshah University of Medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria :minimal time of hemodialysis : 3 mount ?IRLSSG scale more than 10? Patient`s age more than 15 years Exclusion criteria: Under treatment with psychotropic agents during recent 2 weeks?presence of another neurologic disease comorbid with ESRD for example CVA, MS and etc.?Iron deficiency anemia?Pregnancy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of RLS. Timepoint: At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study). Method of measurement: with IRLSSG scale.;Severity of sleep disorder. Timepoint: At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study). Method of measurement: with pittsburg sleep quality index.;Quality of life. Timepoint: At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study). Method of measurement: with SF-36 (scale of quality of life).;Day time sleepiness. Timepoint: At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study). Method of measurement: Epworth sleepiness scale.

Secondary

MeasureTime frame
Drug advers reaction. Timepoint: At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study). Method of measurement: with question from patients.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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