Cannabidiol in Restless Leg Syndrome

Phase 2

Recruiting

• Conditions: Restless Leg syndrome.; Restless legs syndrome; G25.81

• Registration Number: IRCT20210901052359N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Fulfill RLS criteria based on International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria 2014
Normal CBC, serum AST, ALT, Alp, BUN, Cr
Serum ferritin level above 50 ng/ml
Informed consent

Exclusion Criteria

Taking drugs that have a hepatic metabolism such as warfarin, anticonvulsants, antibiotics
Taking dopamine antagonist drugs and other RLS treatment drugs during the past month
History of drug abuses and impulse control disorders
History of other sleep disorders
History of other diseases related to the peripheral and central nervous systems
History of cardiovascular, liver, kidney diseases and arrhythmia
Pregnancy, lactation and patients using unsafe contraceptive methods
Soy allergy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restless Legs Syndrome Rating Scale. Timepoint: before intervention, 4 and 8 weeks after intervention. Method of measurement: Restless Legs Syndrome Rating Scale.