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Determining the effect of FamiLact probiotic on improving the symptoms of restless leg syndrome

Determining the effect of FamiLact probiotic on improving the symptoms of restless leg syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240819062807N1
Enrollment
70
Registered
2024-10-18
Start date
2024-09-05
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Restless leg syndrome and sleep disorder. Restless legs syndrome

Interventions

Intervention 1: Intervention group: In addition to common treatments, which is pramipexole, the intervention group will receive one 500 mg tablet of Familact probiotic (from Zist takhmir Pharmaceutica

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 55 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of restless legs syndrome based on the opinion of the attending physician and the criteria of the International Restless Legs Syndrome Association A history of at least three months of illness Consent to participate in the study

Exclusion criteria

Exclusion criteria: Not taking drugs other than prescribed drugs (psychoactive and sedative) Not suffering from other chronic diseases (kidney failure, diabetes, uremia) Not being pregnant

Design outcomes

Primary

MeasureTime frame
Severity of the RLS disease. Timepoint: The severity of the disease (restless leg syndrome) of the patients are checked once before the intervention and once after two months after the drug treatment. Method of measurement: IRLS Questionnaire.

Secondary

MeasureTime frame
Sleep quality. Timepoint: The sleep quality of the patients is checked once before the intervention and once after two months after drug therapy. Method of measurement: Pittsburgh Sleep – PSQI Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Haghighat Khah

Arak University of Medical Sciences

mhkq77@gmail.com+98 25 3784 8681

Outcome results

None listed

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